From 635cfe42d97573126068fe040c1f00ee904d92fa Mon Sep 17 00:00:00 2001 From: will king Date: Mon, 7 Oct 2024 11:29:48 -0700 Subject: [PATCH] added new data on reasons for terminating trials --- .../reasons_why_stopped.csv | 1002 ++ .../reasons_why_stopped.fods | 11473 ++++++++++++++++ 2 files changed, 12475 insertions(+) create mode 100644 other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.csv create mode 100644 other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.fods diff --git a/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.csv b/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.csv new file mode 100644 index 0000000..9d66391 --- /dev/null +++ b/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.csv @@ -0,0 +1,1002 @@ +"why_stopped" +IDMC recommendation +Recruitment was below expectation +delay +New Related Protocol to be submitted +See termination reason in detailed description. +"Due to the end of the ARVI and influenza season, it has been suspended until approximately October 01, 2022" +"Unable to fulfill intention of study, lost investigators." +Due to Covid-19 +Terminated early for insufficient evidence of clinical efficacy +Low enrollment +The primary investigator moved. +early termination due to Sponsor decision (slow recruitment) +Lack of financial support +Lack of accrual +Organizational issues and slow inclusion rate +See termination reason in detailed description. +Due to a low recruitment rate since start of recruitment period. +Recent similar studies have been completed and published showing no benefit to the intervention. +Study terminated due to sponsor decision +inclusion difficulties +Inability to recruit eligible subjects +budgetary reason +Therapy shown effective by larger studies +lack of enrollment +Study was never opened due to lack of funding +Lack of accrual +Results were obtained in another project. +Withdrawn due to business reasons +not enough recruitment +Study halted prematurely during COVID-19 outbreak (only 1 participant) +Primary objective of the trial was not met and so there was no benefit in collecting further information +enrollment problem +Halted Prematurely +Slow enrollment and due to personnel change there was no viable way to quantify glycine levels through imaging +Low patient accrual +"Current program is on hold, not for safety reason" +company prioritization reasons +Company decision has been taken in light of recent demands by certain national health authorities +Clinical trial was cancelled +Never recruited any patients. +"low recruitment, end of COVID-19 pandemic" +Obtained results were not good. Protocol was proved ineffective. +Department chair choose not to participate +Low Recruitment +Slow patient enrollment and study discontinued after 14 patients enrolled +The planned recruitment number of 180 Patient could not been achieved. +No participants enrolled +"Unfortunately, Deciphera management decided to not move forward with the rebastinib program and are terminating early." +The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol +Requested by PI during yearly Continuing Review +Termination of study due to low enrollment. There were no safety issues. +No funding available. +No participants enrolled into study and protocol has been superseded +Funding +poor recruitment and an unexpected low treatment rate +Investigator left institution. +Corporate decision +Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided. +An interim analysis showed no difference in major outcomes (n=35 glycine and n=24 control participants) +Terminated as marketing of this product will be discontinued +Difficulty enrolling eligible subjects +Technical issues with RSA at main site and departure of Principal Investigator +The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004 +Covid-19 Closures & Lockdown +Research Cancelled +Administratively complete. +Low accrual +There were not patients that meet inclusion/exclusion criteria. Site decided to close study. +unable to reach enrollment goal +safety +Study not funded. +Because of technical problems (researcher moved to different city). +Study terminated because unable to obtain access to study drug for study population. +Funding ceased +Study was terminated because of conflicting results from intermediate analysis. +Sponsor determined that it must be terminated +"Recommendation of DSMB for safety issue, increased mortality with study drug." +The device was withdrawn from clinical use +This study was cancelled. +the research sponsors stopped further funding due to a planning of a multi-center trial +funding +no participants enrolled +COVID epidemic +The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies] +The study was stopped due to futility +Study ended after review +Difficulty recruiting +The study treminated early according to DSMB recommendantions +A decision was made to discontinue the study due to a change in the strategic direction of the company. +Based on newly available preclinical data we changed the CAR construct to a more effective version and will now study that product on a different protocol. +Study was terminated due to low accrual. +Due to the product being discontinued +compound no longer available +Study never initiated in Cambodia +"Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed." +Safety of patients : CSI recommandation and promotor decision +Lack of effect in Cohort 1 +lack of enrollment +Terminated due to COVID-19 +Amgen decision following interim review of efficacy and safety data from the AMG 337 program. +The study was combined with our Urine and Stool Study (NCT01637506). +Due to company resource constraints +Company Decision +due to celecoxib safety issues +Poor recruitment +New data: The study was terminated based on new efficacy data from another study +"Poor enrollment, inability to achieve required number of subjects" +Due to operational changes at the participating agency. +COVID-19 +The study was not started due to the lack of funding. +Due to the business issues. Manufacturer has been acquired by other company. +Delayed subject enrollment +Awaiting additional safety data +"Based on results of another phase II study with bintrafusp alfa in combination with gemcitabine plus cisplatin, that was discontinued as it was unlikely to meet the primary endpoint of OS, the recruitment for this study was stopped prematurely." +Lack of enrollment +Annual accrual goal not met +early discontinuation based on strategic sponsor decision not driven by any safety concerns +Low accrual rate +Not meeting primary objective of the study +because of lack of funding and recruitment problems the study has been closed. +Funding for project was withdrawn +PI left hospital +Study was terminated after unplanned interim analysis of single centre data and results were reported +lack of funding +Results from other studies did not support continuation of this trial +Funding obtained to do a larger placebo-controlled trial +At interim analysis insufficient benefit was observed to continu the study +Study suspended +Due to out-of-date design and non-compliance. +COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants. +Study was withdrawn prior to R&D approval +Issues w/ sponsor and recruitment +IRB approval expired +"Due to staffing changes in the hospital, we will be unable to complete this study for the requested 84 subjects. As such, we have decided to close this study." +Lack of funding/support +Unable to accrue to the study. Original PI no longer with the institute. +Request of Health Canada after publication of https://doi.org/10.7326/M20-4207 +Decision of independent monitoring committee: Risk of non-response to treatment significantly higher in midodrine group than in terlipressin group. +low recruitment +Study halted at interim analysis to allow the sponsor to focus on a new study with different design. +COVID-19 +Sponsor cancelled the study +The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation. +Interim analysis of data failed to meet primary endpoint. +COVID-19 protocols have curtailed recruitment. We anticipate resuming the study when safe to do so. +In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure +The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study +Company withdrew interest +Withdrawn due to transfer of Investigator +no patient accruals +"STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE" +protocol withdrawn +technical problems +Study design was inadequate and would not achieve study endpoints +PI left +few delirious patients were enrolled. +The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit. +Inability to recruit subjects +slow enrollment +"The trial has terminated due to changes in standard of care since its activation, which has led to poor accrual." +Terminated because sample size achieved +We did not found voluntary subjects +As a result of COVID-19 pandemics +Lack of participants +This study is withdrawn due to feasibility issues. +"No participant enrollment, funding withdrawn." +Per sponsor's decision +The study was discontinued prematurely due to early stopping rules. +Insufficient eligible patients +Difficult recruitment +Pending FDA approval +toxicities were worse than expected +New funding required +Slow accrual +Both the sponsors and collaborator are considering terminating the study +Terminated due to inefficacy of the tested method +Award not yet received and PI is transferring to a different institution +Terminated after completion of Part 1 due to a change in research plan. +withdrawn before IRB approval +Poor accrual +Material sponsor withdrew support +The trial was terminated because of deviations from the protocol. +low incidence +The decision to stop enrollment was due to strategic considerations and not due to any specific safety reasons or request from a regulatory authority. +Sponsor has decided to not proceed with this study. +The study was discontinued after the first pre-planned interim analysis due to insufficient response rates. +Lack of enrollment +Principal Investigator no longer with university. +The study was withdrawn due to difficult recruitment of patients for the study; No participants were enrolled in the study. +Change of location for Investigators +This study has been terminated due to meeting protocol defined futility. +Change of MRI mode +The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program. +See Detailed Description. +Biochemical measurement techniques were deemed insufficient to continue research +Data collection was terminated due to unavailability of additional participants. +Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression. +Failure to enroll sufficient patients by expected deadline. +did not have resources to continue this study +Business Reasons +Sponsor to focus on hospitalised patients +no longer recruiting or studying +The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product. +Changing study design. Will replace with a different protocol. +According to Sponsor decision. +Discontinued due to incomplete recruitment +unable to enroll +Poor recruitment +Safety concerns (IgM Flare) +Sponsor suspension and not due to safety or site-related matters. +Study withdrawn by funding organization with no participants enrolled +Conflicting interim data +"Business decision, insufficient enrollment, no safety or efficacy concerns." +the study never started +Withdrawn due to lack of accrual +No patient accrual +Enrolling 8 more patients would be statistically unlikely that the primary endpoint would be reached (reduce day 180 grade II-IV GVHD rates to 20% or less) +COVID-19 pandemic +The company DNage is in receivership and no longer functional +Sponsor terminated study early to start a larger feasability study +"Funding problems, slow recruitment, PI location change" +No longer practical to deliver treatment +Business Decision; No Safety Or Efficacy Concerns +Executive committee determined to close study after interim analysis. +Evidence that the dose is insufficient. +decided by the sponsor +prototype catheter never delivered +The PI moved to another city and position +Nonapplicable clinical trial +The study closed due to poor accrual and difficulty with participant compliance. +Difficulties with recruitment +Requested by PI during yearly Continuing Review +none enrolled per PI +Company no longer operational +Slow recruitment +Poor recruitment rate. +company decision to terminate +PI no longer at institution +Project moved to new university +Based upon results of interim data analysis +PI left the institution +Due to slow accrual +The study team was unable to secure sufficient funding and administrative support. +Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution +recruiting or enrolling participants has halted prematurely and will not resume +lack of recruitment +Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU. +PI has left the institution +Funding not enough to complete the study +PI is leaving the institution +The study was terminated prematurely because of difficulty with recruiting. +Low enrollment rates +Low accrual. +Failed funding application. +Investigator left institution and did not retain the study +Due to lack of funding +drug no longer available in canada +Sponsor cancelled study +The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine. +due to difficulties with recruiting +"Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%." +Due to administrative reasons +Sponsor's decision of the Early Termination of the study. +Poor enrollment +insufficient efficacy +Lower enrollment rate than expected +"By DSMB on October 18, 2013 due to increased incidence of ARDS. See modified protocol [NCT02175225" +The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP. +recruitments issues +Sub-investigator left facility prior to study initiation +The study was not started and prematurely closed. +PI on an extended leave of absence. +Grant projects were revised in response to COVID-19. +Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns. +Insufficient Resources +accrual of evaluable subjects too low +Administratively terminated. +Funding expired +"Late approval by the Secretariat of Health, and expiration of vaccine" +"grant was not approved, no subjects enrolled" +Negativity of the first results of in vivo binding of 18F-PBR06 +"The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576." +Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described. +Recruitment halted prematurely due to competitive landscape for lung cancer therapies +Lack of funding +difficulties in including patients +The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years). +Study team was unable to effectively conduct the study. +The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox. +The study was terminated due to program discontinuation. +Lead investigator moved to a new medical center; study was stopped when he left. +The study was terminated early as it failed to recruit. +Study suspended for safety reasons. +Grant application was not funded +lack of funding +Clinical study terminated due to preclinical safety findings in non-human primates. +recruitment difficulties +Closed by CHUM REB for incomplete documentation of research activities. +No safety issues. Need to rewrite protocol +the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded. +Low enrollment +Inadequate recruitment due to COVID-19 +as of 4/23/97 +Difficulty to continue follow-up during the coronavirus epidemic +Protocol procedure did not adequately meet data needs for the study. +"Terminated in lieu of similar,competing large, multi-site study." +An interim analysis did not warrant to continue enrollment +Funding +Study temporarily suspended by NIMH +Resource Constraints +Study halted by sponsor due to slow enrollment. +"Final analysis done, follow-up of patients no more necessary" +Due to the COVID-19 pandemic +Unable to recruit necessary sample size +"Enrollement target could not be achieved, study will not resume" +Trials was stopped early due to lack of funding. +Business decision to stop the program +NIH funding ended prior to full enrollment in the clinical study +"Accrual goal met, pending new cohort activation" +Loss of funding. +Withdrawn due to slow accrual +unable to replace Fellow conducting the study who left institution in 2007 +Enrollment is temporarily paused to allow other studies to be conducted and may resume in the future. This is not a suspension of IRB approval. +Research cancelled +"Study is withdrawn due to no enrollment, due to COVID pandemic." +No IND submitted to the FDA +Not approved by CMS +Funding ended +Sponsor the return rights of the compound to the collaboration partner for further clinical development +classified by the IRB as non human subjects research +The principal investigator left the center in 2016. +Very slow recruitment - only 3 patients randomised +No longer pursuing study at our site. +No recruitment was achievable +By recommendation from the Data and safety monitoring board +Failure to recruit sufficient numbers due to the pandemic +Study terminated due to potential safety concerns in combination with platinum-based therapies +The intervention (PulsePoint application) could not be implemented in Toronto as planned +This study was suspended because there is no more funds to complete the study. +Clinical workflow was too high +no participants enrolled +Awaiting results from sub analysis to decide if study continuesé +There was a delay in getting protocol approvals and hence the study would not be completed in time. +MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years. +For business reasons +The app was not completed in time to conduct a clinical trial on it within the funding grant's award period +Pending COVID-19 pandemic; pending product development +Change in staffing and not able to do study +Funding +lack of viability +COVID shutdown +Termination due to lack of adequate enrollment +Decision to not proceed with study. +Technical problems +We will not be pursuing this study. +Principle Investigator as left government service +Terminated for lack of enrollment +Poor recruitment +"Because the investigator's workplace and department have been changed, this study cannot be carried out." +No adequate funding +This study is terminated due to COVID-19 pandemic +Study was conducted to fulfill a post marketing commitment (PMC 6). FDA acknowledged fulfillment of PMC. +Low patient recruitment +PI leaving institution: Will not continue study. +Business Decision; No Safety Or Efficacy Concerns. (See below) +Study not started +Medication removed from the U.S. market by the The Food and Drug Administration +no funding to purchase study device +Preliminary analyses of data indicated study should be terminated for futility +"Face-to-face appointments, which were required by the IRB for suicide risk evaluation, were suspended by the IRB during the COVID-19 pandemic. During this pause, the PI left the institution. Thus, all study activities were terminated." +Other - Stage 1 has met accrual +Lack of funds +Lack of funding +low recruitment rate +toxicity +Short of supply of fibrin glue +terminated due to lack of enrollment +Could not find interested researchers/clinicians to complete study protocol. +Changes in availability of study personnel +Study withdrawn. No participants enrolled. +No patients +At interim analysis the study did not meet the response criteria to continue +The study did not receive anticipated funding and therefore never opened to enrollment. The study was never submitted to the IRB for approval since the funding failed. +for inability to enroll subjects. +DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates +No study population in Mexico (H1N1). Study withdrawn from IRB consideration. +"Administrative reasons, and did not meet sample size requirements" +Never started enrollment due to logistics. +No accrual. +Lack of recruitment due to low acceptance of the control arm. +Sponsor decision based on portfolio prioritization +"Difficult enrollment, no subjects identified to enroll" +"Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency" +The study was not able to enroll any eligible subjects. +This study was canceled for operational reasons. +Slow accrual +This is not a human subject's study. Protocol registered in error. This protocol studied nursing homes as a unit. +Lack of recruitment +administrative hurdles +FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds +"Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial" +Insufficient Accrual +Study closed due to lack of enrollment +No patient has never been included in the trial +Lack of funding +no recruitment on time +FDA will not authorize COVID-19 Ab tests for use over-the-counter. +Sponsor is focusing on studies which can enable registration of duvelisib +"Problems recruiting patients (not willing, travel time, no respons)" +lack of inclusions +Pending needed additional funding/resources +Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible. +insufficient recruitment +Not able to find enough eligible patients (200) in last 4 years. +"Slow recruitment, lack of continued funding" +Toxicity +low recruitment rate +Slow/insufficient accrual and investigators have left the study. +Corporate Decision +Very slow recruitment of patients and the current COVID-19 pandemic situation. +Drug development suspended by current holder of IND +Withdrawn by PI +Subject Recruitment +"If 1 year of inactivity. +Slow accrual +We planed to study later +Recruitment and feasability issues +No patients enrolled due to change in standard practice +pending expiration of the supply of study agent. +Interim futility analyses identified a lack of SYNB1020 efficacy. +No more potentiel patients for study +Study withdrawn due to lack of available patients meeting entry criteria +Business decision +Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant +Unable to enroll eligible participants +No enrollment +Practice patterns with pemetrexed have evolved. +IND has been closed. +Lack of funding +Replaced by another protocol +Reformulation of study drug to help reduce the pill burden as higher doses are evaluated. +It became unlikely to achieve the study objective of 50% reduction over published inhibitor rates. The Data Monitoring Committee supported this decision. +the chosen intervention was obviously ineffective +Recruitment not satisfactory +Low accrual +Change in referral pattern changed the population we were studying +"New departmental administration, loss of key study faculty" +Funding withdrawn due to delay in FDA IND submission +Funding +COVID-19 Pandemic interfered with Pt recruitment +Study never approved by IRB or initiated +an interim analysis was provided for in the protocol. The results are unsatisfactory +Could not be completed due to technology problems and cost constraints +The PI left the university +Design of the study device will be modified +safety issues (toxicity) +Sponsor terminated the study. +Interim analysis found study had achieved primary objective +Use of bupropion with counseling works better to help patients quit smoking. +funding unavailable +Never funded +"Study was terminated due to lack of interest from subjects and no funding, only 1 subject signed consent but did not participate." +Unable to recruit subjects - unworkable +Business Decision +Sponsor's decision +Study was closed and reopened as NCT01717391 +Business decision to end study due to limited enrollment and study population +Study was withdrawn due issuses related to the science +Person working on the trial left +Slow recruitment +low accrual +lack of recruitment +Business Decision +Large and sustained difference in pregnancy rate +insufficient recruitment +PI has requested for this study be closed due to technical issues +The study never started +Stopped for one complication event (arterial occlusion) +COVID-19 pandemic +Treatment Ineffective +Problem with drug supply +Inadequate recruitment +The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile. +Researchers left institution +Study never initiated +PI no longer at facility. +Due to low enrollment. +Study objectives met +Site did not want to pursue study +Study terminated by the Sponsor +Investigator's decision +Appropriate devices for fetal heart rate monitoring were not available. +Lacking of funding +Limitaiotn of financial support +"Infusion reactions during re-induction cycles after a period of no treatment. Please see ""Purpose"" section." +Lack of budget +competing protocol +Poor accrual +FDA recommendation +Business decision +The investigators were not able to get grant funding for this study. +Difficulty with recruiting +IRB not approved +Terminated: Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint. +This study has closed to accrual early due to slow accrual. +Vaccines safe but not immunogenic in 8 participants; trial closed to further recruitment by the protocol steering committee & DSMB. +Study classified as out of scope by the Ethics Committee (not a project involving human person). +Slow Enrollment +Scheduled Interim Monitoring +Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place. +Enrollment held for toxicity evaluation; then closed due to competing trial +P. I. left the Institution. Study never opened +Failure to recruit people with very late onset schizophrenia like psychosis +See statement in Detailed Description. +Funding +It's no longer feasible to continue to recruit patients into the study as severe recruitment difficulties have been experienced since the study start +No participaints enrolled +Terminated early by Sponsor for business reasons unrelated to safety. +PI leaving +recruitment problem +"Slow to accrue, lack of qualified participants" +no sponsor support +Study halted prematurely and will not resume. Subjects were seen until February 2017 +Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study. +Poor enrollment +Resource and time constraints were encountered by product manufacturer and study team. +prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ +"Our study stopped before it could begin because of the Covid-19 pandemic. We revised the study so that it could be performed virtually, but the revised study isn't a clinical trial." +Lack of approval and funding from company +Replaced by another study. +Problems recruiting and retaining volunteer research personnel to assist with the recruitment of subjects and the study procedures +no funding +Due to the low rate of primary endpoint events experienced in the study to date +Closed by PI prior to approval +PI no longer wanted to do the study +No significant change for the primary objective at 12 months +Lower recruitment rate than expected +recruitment +PI +lack of accrual +lack of funding +insufficient enrollment +The study was closed due to poor accrual and because of competing protocols. +"The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time." +Specimens are now collected through the BRS protocol. +No funding for the project +Resource constraints at participating sites +Alternative data published +insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased. +Trial funding no longer available. +"This Phase I study was permanently closed to patient accrual on February 23, 2011, due to the discontinuation of support from MERCK." +Lack of enrollment +COVID-19 Impacted Service Delivery and Research Infrastructure +Other - Clinical development of the agent has been discontinued +Based on preliminary parent study results +lack of effectiveness +Novartis terminated all projects involving aliskiren. Findings of the DMC overseeing the ALTITUDE clinical trial found a higher incidence of adverse events. +Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app. +Trial closed due to low accrual +low inclusion rate +"Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out" +The IND was withdrawn. +no longer interested in doing the study +no participants enrolled +no need to include more patients for analysis. 40 patients initially (36 actual) +Due to slow recruitment and recent new published data +Sponsor decision for business purposes +Principal Investigator Left Institution +Lack of time to enroll due to additional responsibilities of the PI and research coordinator. +Unable to recruit participants for this study +Due to recruiting issues +Company suspended development of product. +lack of funding +Difficulty in purchasing reagents and receiving consent from the subject +funding +Manufacturer will not be supporting this study +recruitment failure +Failure to recruit +Study was closed to enrollment before dose level one was completed. +Subject recruitment unable to be completed due to study feasibility issues. +No study population. No subjects enrolled. +Sponsor terminated. No longer needed to support business need +No patients were enrolled +Sponsor decision +Administratively complete. +unable to recruit participants due to political issues +Recruitment challenging: lack of suitable pts; recruiting so soon after diagnosis; competing studies. Funding ended despite extensions to grant. +Administrative barriers +not sufficiency recruitment +Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility +Unable to commence study due to closure of hospital department. +"Seton IRB administratively closed this study on January 6, 2017" +Temporarily suspended due to equipment issues +Strategic considerations +Study terminated due to low subject enrollment. Safety results consistent with product label. +No inclusion +"PI left institution. Protocol not submitted to IRB, contract not executed, and study was not done." +Study did not meet its primary objective +Changes to study personnel. +Unable to find eligible subjects- study closed +low accrual +"The DSMB committee recommended closing the trial because of the COVID-19 risk in this ""at-risk"" oGVHD population if they came for study visits." +unable to enroll participants who meet the criteria +Terminated: higher rate of acute rejection in the Cyclosporin A group +No enrollment. +Lack of funding +The trial was terminated due to investigator's decision +Sponsor's decision +This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns. +The study was terminated approximately 6 months earlier than planned because 227 subjects (59% more than anticipated) had already completed 10-Year Visits due to lower than expected attrition +"Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms." +Challenges with recruitment +No funding obtained +Early termination due to a suspension of financial support +the PI is no longer work at Hadassah +Enrollment challenges +Due to slow accrual +Low recruitment +funding was not secured +Terminated due to a distribution issue with the trial medication +Slow Accrual +- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia. +"Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases." +Lack of support staff +End in funding +poor accrual +"The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated." +no fund +The study was prematurely terminated due to insufficient recruitment. +the trial was discontinued for legislative reasons. +loss of funding +Sponsor withdrew funding +Product discontinued in November 2014 +"Study complexity, low study recruitment" +The study was terminated for business reasons. +recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated +Study not feasible-Not able to enroll the patient population +Original PI left institution. +Common comorbidities of Veterans precluded sufficient recruitment and enrollment. +Principal Investigator withdrew from the study. +Sponsor decision. +Lack of patient enrollment +May 2007: No annual renewal +recruitment efforts did not result in a sufficient number of patients +Low recruitment rates and timeline viability analysis. +Not feasible to recruit and follow-up subjects due to the pandemic +Study site has terminated the study due to the complexity of the study +We found out that there is another study on the same issue +Slow Enrolling +No funding available. +did not apply for ethics renewal +Replaced by new study in progress +Limited participants for enrollment +FDA released from conducting +Funding ended +"Principal Investigator moved to Jacksonville, FL campus." +Zero Patients met criteria +The study was terminated early on 03/09/2022 due to low accrual during the COVID-19 pandemic. +inability to meet enrollment goals in this subject population +Strategic decision +Planned interim analysis demonstrated futility of intervention +no one enrolled; PI left institution +"Study was not able to be completed, no results analyzed." +Awaiting verification of assay +It was difficult to recruit patients to get the appropriate sample size. +PI has left the study institution. +Lack of Funding +Study ended due to difficulties in recruitment and low enrollment. +Injection site reaction met protocol-defined stopping criteria. +Other - Protocol moved to Disapproved +The researchers were unable to answer the study question by utilizing the insurance claims database. +The sponsor terminated funding for the study. +Unable to find adequate funding +Lack of accrual. We were unable to enroll enough participants to have meaningful results. +Lack of funding +Study not funded +The Sponsor's decision to terminate the SBC-103 program was reached after review of the data from all interventional clinical studies of SBC-103. +Lack of Accrual +Trial was stopped due to difficult enrolment +"Study was not conducted, no subjects recruited." +Pentostatin/alemtuzumab regimen had greater risk of graft failure. +did not receive funding +insufficient number of inclusion +Enrollment closed +Futility boundary at interim analysis not met +issue concerning safety of elastography during pregnancy +CHU Lyon will join as a participating center (and as national French coordinator) as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14. +The preliminary result didn't show any benefit. +slow accrual and financial resource limitation +Study design is not reasonable and sponsor decided to terminate the study. No patient enrolled by now +physician decision to stop study early due to low enrollment +"Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time." +The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods +because of low rate recruitment and the inability to reach the target expected +Not enough patients +Low recruitment in intervention study. Baseline data published. +Study stopped due to product discontinuation by manufacturer +Lack of enrollment +Funding unavailable +Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants. +Designed a new modified/simplified protocol see NCT 03180489 +Not enough inclusions. +participants are no longer being examined or receiving intervention +Per memo from study team +Sponsor's clinical development strategy adjustment +Business Decision +"There has been no unanimous approval by the investigators regarding the approval of the study protocol. Therefore, by mutual agreement, sponsor and investigators have taken the decision to withdraw the clinical study." +Due to an imbalance in graft infections between groups. +The study is out of date +difficulty in recruiting subjects +Study suspended because of safety reasons +Low recruitment of participants for the study +Due to COVID pandemic +Primary Investigator left UT Southwestern and was not replaced. +Administrative +key investigator relocated. + diff --git a/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.fods b/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.fods new file mode 100644 index 0000000..02805d3 --- /dev/null +++ b/other_data/RandomSample_AACT_reasons_why_stopped/reasons_why_stopped.fods @@ -0,0 +1,11473 @@ + + + + 2024-10-07T11:28:18.152837946P3DT14H58M40S3LibreOffice/6.4.7.2$Linux_X86_64 LibreOffice_project/40$Build-2 + + + 0 + 0 + 42490 + 519920 + + + view1 + + + 3 + 2 + 0 + 0 + 0 + 0 + 2 + 0 + 0 + 0 + 0 + 0 + 100 + 60 + true + false + + + 2 + 192 + 0 + 2 + 0 + 1 + 2 + 0 + 0 + 0 + 180 + 0 + 100 + 60 + true + false + + + reasons_why_stopped + 1900 + 0 + 100 + 60 + false + true + true + true + 12632256 + true + true + true + true + false + false + false + 1270 + 1270 + 1 + 1 + true + false + + + + + true + true + true + false + 1270 + true + 1 + 12632256 + true + true + true + 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 + 1270 + 7 + false + true + true + 1 + true + + + en + US + + + + + + false + true + false + true + true + Brother-HL-L2350DW + false + 0 + 3 + true + false + false + false + true + false + true + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + % + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + ??? + + + + Page 1 + + + + + + + ???(???) + + + 00/00/0000, 00:00:00 + + + + + Page 1/ 99 + + + + + + + + + + + + + + + + + + + why_stopped + + + Safety/Efficacy issues + + + Enrollement/Accrual problems, + + + Pandemic/COVID19, + + + Funding problems, + + + Issue with sponsor/Principle Investigator/Company, + + + protocol change + + + Other operational challeng + + + Other challenge + + + Other study + + + Marked + + + + + + IDMC recommendation + + + 1 + + + + 1 + + + + + + Recruitment was below expectation + + + + 1 + + + + 1 + + + + + + delay + + + + 1 + + + + 1 + + + + + + New Related Protocol to be submitted + + + + 1 + + + + 1 + + + + + + See termination reason in detailed description. + + + + 1 + + + + 1 + + + + + + Due to the end of the ARVI and influenza season, it has been suspended until approximately October 01, 2022 + + + + 1 + + + + 1 + + + + + + Unable to fulfill intention of study, lost investigators. + + + + 1 + + + + 1 + + + + + + Due to Covid-19 + + + + 1 + + + + 1 + + + + + + Terminated early for insufficient evidence of clinical efficacy + + + 1 + + + + 1 + + + + + + Low enrollment + + + + 1 + + + + 1 + + + + + + The primary investigator moved. + + + + 1 + + + + 1 + + + + + + early termination due to Sponsor decision (slow recruitment) + + + + 1 + + + + 1 + + + + + + Lack of financial support + + + + 1 + + + + 1 + + + + + + Lack of accrual + + + + 1 + + + + 1 + + + + + + Organizational issues and slow inclusion rate + + + + 1 + + + + 1 + + + + 2 + + + + + + See termination reason in detailed description. + + + + 1 + + + + 1 + + + + + + Due to a low recruitment rate since start of recruitment period. + + + + 1 + + + + 1 + + + + + + Recent similar studies have been completed and published showing no benefit to the intervention. + + + 1 + + + + 1 + + + + + + Study terminated due to sponsor decision + + + + 1 + + + + 1 + + + + + + inclusion difficulties + + + + 1 + + + + 1 + + + + + + Inability to recruit eligible subjects + + + + 1 + + + + 1 + + + + + + budgetary reason + + + + 1 + + + + 1 + + + + + + Therapy shown effective by larger studies + + + + 1 + + + 1 + + + + + + lack of enrollment + + + + 1 + + + + 1 + + + + + + Study was never opened due to lack of funding + + + + 1 + + + + 1 + + + + + + Lack of accrual + + + + 1 + + + + 1 + + + + + + Results were obtained in another project. + + + + 1 + + + 1 + + + + + + Withdrawn due to business reasons + + + + 1 + + + + 1 + + + + + + not enough recruitment + + + + 1 + + + + 1 + + + + + + Study halted prematurely during COVID-19 outbreak (only 1 participant) + + + + 1 + + + + 2 + + + + + + Primary objective of the trial was not met and so there was no benefit in collecting further information + + + + 1 + + + + 1 + + + + + + enrollment problem + + + + 1 + + + + 1 + + + + + + Halted Prematurely + + + + 1 + + + + 1 + + + + + + Slow enrollment and due to personnel change there was no viable way to quantify glycine levels through imaging + + + + 1 + + + + 1 + + + + 2 + + + + + + Low patient accrual + + + + 1 + + + + 1 + + + + + + Current program is on hold, not for safety reason + + + + 1 + + + + 1 + + + + + + company prioritization reasons + + + + 1 + + + + 1 + + + + + + Company decision has been taken in light of recent demands by certain national health authorities + + + + 1 + + + + 1 + + + + + + Clinical trial was cancelled + + + + 1 + + + + 1 + + + + + + Never recruited any patients. + + + + 1 + + + + 1 + + + + + + low recruitment, end of COVID-19 pandemic + + + + 1 + + + + 2 + + + + + + Obtained results were not good. Protocol was proved ineffective. + + + 1 + + + + 1 + + + + + + Department chair choose not to participate + + + + 1 + + + + 1 + + + + + + Low Recruitment + + + + 1 + + + + 1 + + + + + + Slow patient enrollment and study discontinued after 14 patients enrolled + + + + 1 + + + + 1 + + + + + + The planned recruitment number of 180 Patient could not been achieved. + + + + 1 + + + + 1 + + + + + + No participants enrolled + + + + 1 + + + + 1 + + + + + + Unfortunately, Deciphera management decided to not move forward with the rebastinib program and are terminating early. + + + + 1 + + + + 1 + + + + + + The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol + + + + 1 + + + + 1 + + + + + + Requested by PI during yearly Continuing Review + + + + 1 + + + + 1 + + + + + + Termination of study due to low enrollment. There were no safety issues. + + + + 1 + + + + 1 + + + + + + No funding available. + + + + 1 + + + + 1 + + + + + + No participants enrolled into study and protocol has been superseded + + + + 1 + + + + 1 + + + + 2 + + + + + + Funding + + + + 1 + + + + 1 + + + + + + poor recruitment and an unexpected low treatment rate + + + + 1 + + + + 1 + + + + + + Investigator left institution. + + + + 1 + + + + 1 + + + + + + Corporate decision + + + + 1 + + + + 1 + + + + + + Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided. + + + + 1 + + + + 1 + + + + + + An interim analysis showed no difference in major outcomes (n=35 glycine and n=24 control participants) + + + 1 + + + + 1 + + + + + + Terminated as marketing of this product will be discontinued + + + + 1 + + + + 1 + + + + + + Difficulty enrolling eligible subjects + + + + 1 + + + + 1 + + + + + + Technical issues with RSA at main site and departure of Principal Investigator + + + + 1 + + + + 1 + + + + + + The company decided to cancel this study in conformity with Philippines FDA Circular 2013-004 + + + + 1 + + + + 1 + + + + + + Covid-19 Closures & Lockdown + + + + 1 + + + + 1 + + + + + + Research Cancelled + + + + 1 + + + + 1 + + + + + + Administratively complete. + + + + 1 + + + 1 + + + + + + Low accrual + + + + 1 + + + + 1 + + + + + + There were not patients that meet inclusion/exclusion criteria. Site decided to close study. + + + + 1 + + + + 1 + + + + + + unable to reach enrollment goal + + + + 1 + + + + 1 + + + + + + safety + + + 1 + + + + 1 + + + + + + Study not funded. + + + + 1 + + + + 1 + + + + + + Because of technical problems (researcher moved to different city). + + + + 1 + + + + 1 + + + + + + Study terminated because unable to obtain access to study drug for study population. + + + + 1 + + + + 1 + + + + + + Funding ceased + + + + 1 + + + + 1 + + + + + + Study was terminated because of conflicting results from intermediate analysis. + + + 1 + + + + 1 + + + + + + Sponsor determined that it must be terminated + + + + 1 + + + + 1 + + + + + + Recommendation of DSMB for safety issue, increased mortality with study drug. + + + 1 + + + + 1 + + + + + + The device was withdrawn from clinical use + + + 1 + + + + 1 + + + + + + This study was cancelled. + + + + 1 + + + + 1 + + + + + + the research sponsors stopped further funding due to a planning of a multi-center trial + + + + 1 + + + + 1 + + + + + + funding + + + + 1 + + + + 1 + + + + + + no participants enrolled + + + + 1 + + + + 1 + + + + + + COVID epidemic + + + + 1 + + + + 1 + + + + + + The decision to terminate the trial was based on the slow rate of recruitment across the programme of studies] + + + + 1 + + + + 1 + + + + + + The study was stopped due to futility + + + + 1 + + + + 1 + + + + + + Study ended after review + + + 1 + + + + 1 + + + + + + Difficulty recruiting + + + + 1 + + + + 1 + + + + + + The study treminated early according to DSMB recommendantions + + + 1 + + + + 1 + + + + + + A decision was made to discontinue the study due to a change in the strategic direction of the company. + + + + 1 + + + + 1 + + + + + + Based on newly available preclinical data we changed the CAR construct to a more effective version and will now study that product on a different protocol. + + + + 1 + + + + 1 + + + + + + Study was terminated due to low accrual. + + + + 1 + + + + 1 + + + + + + Due to the product being discontinued + + + + 1 + + + + 1 + + + + + + compound no longer available + + + + + + + + + + Study never initiated in Cambodia + + + + + + + + + + Investigators and Ethic Committee endorsed early suspension of the protocol because of superiority and safety. For the interim analysys, the statistical methodology presented by Pocock was followed. + + + 1 + + + + 1 + + + + + + Safety of patients : CSI recommandation and promotor decision + + + 1 + + + + 1 + + + + + + Lack of effect in Cohort 1 + + + 1 + + + + 1 + + + + + + lack of enrollment + + + + 1 + + + + 1 + + + + + + Terminated due to COVID-19 + + + + 1 + + + + 1 + + + + + + Amgen decision following interim review of efficacy and safety data from the AMG 337 program. + + + 1 + + + + 1 + + + + + + The study was combined with our Urine and Stool Study (NCT01637506). + + + + 1 + + + + 1 + + + + + + Due to company resource constraints + + + + 1 + + + + 1 + + + + + + Company Decision + + + + 1 + + + + 1 + + + + + + due to celecoxib safety issues + + + 1 + + + + 1 + + + + + + Poor recruitment + + + + 1 + + + + 1 + + + + + + New data: The study was terminated based on new efficacy data from another study + + + + 1 + + + 1 + + + + + + Poor enrollment, inability to achieve required number of subjects + + + + + + + + + + Due to operational changes at the participating agency. + + + + 1 + + + + 1 + + + + + + COVID-19 + + + + 1 + + + + 1 + + + + + + The study was not started due to the lack of funding. + + + + 1 + + + + 1 + + + + + + Due to the business issues. Manufacturer has been acquired by other company. + + + + 1 + + + + 1 + + + + + + Delayed subject enrollment + + + + 1 + + + + 1 + + + + + + Awaiting additional safety data + + + 1 + + + + 1 + + + + + + Based on results of another phase II study with bintrafusp alfa in combination with gemcitabine plus cisplatin, that was discontinued as it was unlikely to meet the primary endpoint of OS, the recruitment for this study was stopped prematurely. + + + 1 + + + + 1 + + + + + + Lack of enrollment + + + + 1 + + + + 1 + + + + + + Annual accrual goal not met + + + + 1 + + + + 1 + + + + + + early discontinuation based on strategic sponsor decision not driven by any safety concerns + + + + 1 + + + + 1 + + + + + + Low accrual rate + + + + 1 + + + + 1 + + + + + + Not meeting primary objective of the study + + + 1 + + + + 1 + + + + + + because of lack of funding and recruitment problems the study has been closed. + + + + 1 + + + + 1 + + + + 2 + + + + + + Funding for project was withdrawn + + + + 1 + + + + 1 + + + + + + PI left hospital + + + + 1 + + + + 1 + + + + + + Study was terminated after unplanned interim analysis of single centre data and results were reported + + + + 1 + + + + 1 + + + + + + lack of funding + + + + 1 + + + + 1 + + + + + + Results from other studies did not support continuation of this trial + + + + 1 + + + 1 + + + + + + Funding obtained to do a larger placebo-controlled trial + + + + 1 + + + + 1 + + + + + + At interim analysis insufficient benefit was observed to continu the study + + + 1 + + + + 1 + + + + + + Study suspended + + + + 1 + + + + 1 + + + + + + Due to out-of-date design and non-compliance. + + + + 1 + + + + 1 + + + + + + COVID 19 resulted in cancellation of all elective surgery therefore we need to terminate the trial with 95 participants. + + + + 1 + + + + 1 + + + + + + Study was withdrawn prior to R&D approval + + + + 1 + + + + 1 + + + + + + Issues w/ sponsor and recruitment + + + + 1 + + + + 1 + + + + 2 + + + + + + IRB approval expired + + + + 1 + + + + 1 + + + + + + Due to staffing changes in the hospital, we will be unable to complete this study for the requested 84 subjects. As such, we have decided to close this study. + + + + 1 + + + + 1 + + + + + + Lack of funding/support + + + + 1 + + + + 1 + + + + + + Unable to accrue to the study. Original PI no longer with the institute. + + + + 1 + + + + 1 + + + + 2 + + + + + + Request of Health Canada after publication of https://doi.org/10.7326/M20-4207 + + + + 1 + + + + 1 + + + + + + Decision of independent monitoring committee: Risk of non-response to treatment significantly higher in midodrine group than in terlipressin group. + + + 1 + + + + 1 + + + + + + low recruitment + + + + 1 + + + + 1 + + + + + + Study halted at interim analysis to allow the sponsor to focus on a new study with different design. + + + + 1 + + + + 1 + + + + + + COVID-19 + + + + 1 + + + + 1 + + + + + + Sponsor cancelled the study + + + + 1 + + + + 1 + + + + + + The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation. + + + + 1 + + + + 1 + + + + + + Interim analysis of data failed to meet primary endpoint. + + + 1 + + + + 1 + + + + + + COVID-19 protocols have curtailed recruitment. We anticipate resuming the study when safe to do so. + + + + 1 + + + + 2 + + + + + + In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure + + + 1 + + + + 1 + + + 2 + + + + + + The study was terminated for business planning purposes. Assessments of APOCIIIRx in this population will be explored in a larger efficacy study + + + + 1 + + + + 1 + + + + + + Company withdrew interest + + + + 1 + + + + 1 + + + + + + Withdrawn due to transfer of Investigator + + + + 1 + + + + 1 + + + + + + no patient accruals + + + + 1 + + + + 1 + + + + + + STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE + + + + 1 + + + + 1 + + + + + + protocol withdrawn + + + + 1 + + + + 1 + + + + + + technical problems + + + + 1 + + + + 1 + + + + + + Study design was inadequate and would not achieve study endpoints + + + + 1 + + + + 1 + + + + + + PI left + + + + 1 + + + + 1 + + + + + + few delirious patients were enrolled. + + + + 1 + + + + 1 + + + + + + The recruitment site (Rush University Medical Center Collaborative Care Program) redefined their service objectives such that IntelliCare was no longer a good fit. + + + + 1 + + + + 1 + + + + + + Inability to recruit subjects + + + + 1 + + + + 1 + + + + + + slow enrollment + + + + 1 + + + + 1 + + + + + + The trial has terminated due to changes in standard of care since its activation, which has led to poor accrual. + + + + 1 + + + + 1 + + + + + + Terminated because sample size achieved + + + + 1 + + + + 1 + + + + + + We did not found voluntary subjects + + + + 1 + + + + 1 + + + + + + As a result of COVID-19 pandemics + + + + 1 + + + + 1 + + + + + + Lack of participants + + + + 1 + + + + 1 + + + + + + This study is withdrawn due to feasibility issues. + + + + 1 + + + + 1 + + + + + + No participant enrollment, funding withdrawn. + + + + 1 + + + + 1 + + + + 2 + + + + + + Per sponsor's decision + + + + 1 + + + + 1 + + + + + + The study was discontinued prematurely due to early stopping rules. + + + 1 + + + + 1 + + + + + + Insufficient eligible patients + + + + 1 + + + + 1 + + + + + + Difficult recruitment + + + + 1 + + + + 1 + + + + + + Pending FDA approval + + + + 1 + + + + 1 + + + + + + toxicities were worse than expected + + + 1 + + + + 1 + + + + + + New funding required + + + + 1 + + + + 1 + + + + + + Slow accrual + + + + 1 + + + + 1 + + + + + + Both the sponsors and collaborator are considering terminating the study + + + + 1 + + + + 1 + + + + + + Terminated due to inefficacy of the tested method + + + + 1 + + + + 1 + + + + + + Award not yet received and PI is transferring to a different institution + + + + 1 + + + + 2 + + + + + + Terminated after completion of Part 1 due to a change in research plan. + + + + 1 + + + + 1 + + + + + + withdrawn before IRB approval + + + + 1 + + + + 1 + + + + + + Poor accrual + + + + 1 + + + + 1 + + + + + + Material sponsor withdrew support + + + + 1 + + + + 2 + + + + + + The trial was terminated because of deviations from the protocol. + + + 1 + + + + 1 + + + + + + low incidence + + + + 1 + + + + 1 + + + + + + The decision to stop enrollment was due to strategic considerations and not due to any specific safety reasons or request from a regulatory authority. + + + + 1 + + + + 1 + + + + + + Sponsor has decided to not proceed with this study. + + + + 1 + + + + 1 + + + + + + The study was discontinued after the first pre-planned interim analysis due to insufficient response rates. + + + 1 + + + + 1 + + + + + + Lack of enrollment + + + + 1 + + + + 1 + + + + + + Principal Investigator no longer with university. + + + + 1 + + + + 1 + + + + + + The study was withdrawn due to difficult recruitment of patients for the study No participants were enrolled in the study. + + + + 1 + + + + 1 + + + + + + Change of location for Investigators + + + + 1 + + + + 1 + + + + + + This study has been terminated due to meeting protocol defined futility. + + + 1 + + + + 1 + + + + + + Change of MRI mode + + + + 1 + + + + 1 + + + + + + The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program. + + + + 1 + + + + 1 + + + + + + See Detailed Description. + + + + 1 + + + 1 + + + + + + Biochemical measurement techniques were deemed insufficient to continue research + + + + 1 + + + + 1 + + + + + + Data collection was terminated due to unavailability of additional participants. + + + + 1 + + + + 1 + + + + + + Enrollment suspended based upon interim analysis subjects allowed to stay on study until disease progression. + + + 1 + + + + 1 + + + + + + Failure to enroll sufficient patients by expected deadline. + + + + 1 + + + + 1 + + + + + + did not have resources to continue this study + + + + 1 + + + + 1 + + + + + + Business Reasons + + + + 1 + + + + 1 + + + + + + Sponsor to focus on hospitalised patients + + + + 1 + + + + 1 + + + + + + no longer recruiting or studying + + + + 1 + + + + 1 + + + + + + The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product. + + + + 1 + + + + 1 + + + + + + Changing study design. Will replace with a different protocol. + + + + 1 + + + + 1 + + + + + + According to Sponsor decision. + + + + 1 + + + + 1 + + + + + + Discontinued due to incomplete recruitment + + + + 1 + + + + 1 + + + + + + unable to enroll + + + + 1 + + + + 1 + + + + + + Poor recruitment + + + + 1 + + + + 1 + + + + + + Safety concerns (IgM Flare) + + + 1 + + + + 1 + + + + + + Sponsor suspension and not due to safety or site-related matters. + + + + 1 + + + + 1 + + + + + + Study withdrawn by funding organization with no participants enrolled + + + + 1 + + + + 1 + + + + 2 + + + + + + Conflicting interim data + + + + + + + + + + Business decision, insufficient enrollment, no safety or efficacy concerns. + + + + + + + + + + the study never started + + + + + + + + + + Withdrawn due to lack of accrual + + + + + + + + + + No patient accrual + + + + + + + + + + Enrolling 8 more patients would be statistically unlikely that the primary endpoint would be reached (reduce day 180 grade II-IV GVHD rates to 20% or less) + + + + + + + + + + COVID-19 pandemic + + + + + + + + + + The company DNage is in receivership and no longer functional + + + + + + + + + + Sponsor terminated study early to start a larger feasability study + + + + + + + + + + Funding problems, slow recruitment, PI location change + + + + + + + + + + No longer practical to deliver treatment + + + + + + + + + + Business Decision No Safety Or Efficacy Concerns + + + + + + + + + + Executive committee determined to close study after interim analysis. + + + + + + + + + + Evidence that the dose is insufficient. + + + + + + + + + + decided by the sponsor + + + + + + + + + + prototype catheter never delivered + + + + + + + + + + The PI moved to another city and position + + + + + + + + + + Nonapplicable clinical trial + + + + + + + + + + The study closed due to poor accrual and difficulty with participant compliance. + + + + + + + + + + Difficulties with recruitment + + + + + + + + + + Requested by PI during yearly Continuing Review + + + + + + + + + + none enrolled per PI + + + + + + + + + + Company no longer operational + + + + + + + + + + Slow recruitment + + + + + + + + + + Poor recruitment rate. + + + + + + + + + + company decision to terminate + + + + + + + + + + PI no longer at institution + + + + + + + + + + Project moved to new university + + + + + + + + + + Based upon results of interim data analysis + + + + + + + + + + PI left the institution + + + + + + + + + + Due to slow accrual + + + + + + + + + + The study team was unable to secure sufficient funding and administrative support. + + + + + + + + + + Study halted prematurely and will not resume participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution + + + + + + + + + + recruiting or enrolling participants has halted prematurely and will not resume + + + + + + + + + + lack of recruitment + + + + + + + + + + Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU. + + + + + + + + + + PI has left the institution + + + + + + + + + + Funding not enough to complete the study + + + + + + + + + + PI is leaving the institution + + + + + + + + + + The study was terminated prematurely because of difficulty with recruiting. + + + + + + + + + + Low enrollment rates + + + + + + + + + + Low accrual. + + + + + + + + + + Failed funding application. + + + + + + + + + + Investigator left institution and did not retain the study + + + + + + + + + + Due to lack of funding + + + + + + + + + + drug no longer available in canada + + + + + + + + + + Sponsor cancelled study + + + + + + + + + + The study was cancelled for scientifically legitimate reasons not related to safety or efficacy of the vaccine. + + + + + + + + + + due to difficulties with recruiting + + + + + + + + + + Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%. + + + + + + + + + + Due to administrative reasons + + + + + + + + + + Sponsor's decision of the Early Termination of the study. + + + + + + + + + + Poor enrollment + + + + + + + + + + insufficient efficacy + + + + + + + + + + Lower enrollment rate than expected + + + + + + + + + + By DSMB on October 18, 2013 due to increased incidence of ARDS. See modified protocol [NCT02175225 + + + + + + + + + + The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP. + + + + + + + + + + recruitments issues + + + + + + + + + + Sub-investigator left facility prior to study initiation + + + + + + + + + + The study was not started and prematurely closed. + + + + + + + + + + PI on an extended leave of absence. + + + + + + + + + + Grant projects were revised in response to COVID-19. + + + + + + + + + + Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns. + + + + + + + + + + Insufficient Resources + + + + + + + + + + accrual of evaluable subjects too low + + + + + + + + + + Administratively terminated. + + + + + + + + + + Funding expired + + + + + + + + + + Late approval by the Secretariat of Health, and expiration of vaccine + + + + + + + + + + grant was not approved, no subjects enrolled + + + + + + + + + + Negativity of the first results of in vivo binding of 18F-PBR06 + + + + + + + + + + The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576. + + + + + + + + + + Modification of the care habits. We believe today that we are no longer able to carry out this study as initially described. + + + + + + + + + + Recruitment halted prematurely due to competitive landscape for lung cancer therapies + + + + + + + + + + Lack of funding + + + + + + + + + + difficulties in including patients + + + + + + + + + + The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years). + + + + + + + + + + Study team was unable to effectively conduct the study. + + + + + + + + + + The immune monitoring data failed to demonstrate an improvement in any biologic endpoint with denileukin diftitox. + + + + + + + + + + The study was terminated due to program discontinuation. + + + + + + + + + + Lead investigator moved to a new medical center study was stopped when he left. + + + + + + + + + + The study was terminated early as it failed to recruit. + + + + + + + + + + Study suspended for safety reasons. + + + + + + + + + + Grant application was not funded + + + + + + + + + + lack of funding + + + + + + + + + + Clinical study terminated due to preclinical safety findings in non-human primates. + + + + + + + + + + recruitment difficulties + + + + + + + + + + Closed by CHUM REB for incomplete documentation of research activities. + + + + + + + + + + No safety issues. Need to rewrite protocol + + + + + + + + + + the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded. + + + + + + + + + + Low enrollment + + + + + + + + + + Inadequate recruitment due to COVID-19 + + + + + + + + + + as of 4/23/97 + + + + + + + + + + Difficulty to continue follow-up during the coronavirus epidemic + + + + + + + + + + Protocol procedure did not adequately meet data needs for the study. + + + + + + + + + + Terminated in lieu of similar,competing large, multi-site study. + + + + + + + + + + An interim analysis did not warrant to continue enrollment + + + + + + + + + + Funding + + + + + + + + + + Study temporarily suspended by NIMH + + + + + + + + + + Resource Constraints + + + + + + + + + + Study halted by sponsor due to slow enrollment. + + + + + + + + + + Final analysis done, follow-up of patients no more necessary + + + + + + + + + + Due to the COVID-19 pandemic + + + + + + + + + + Unable to recruit necessary sample size + + + + + + + + + + Enrollement target could not be achieved, study will not resume + + + + + + + + + + Trials was stopped early due to lack of funding. + + + + + + + + + + Business decision to stop the program + + + + + + + + + + NIH funding ended prior to full enrollment in the clinical study + + + + + + + + + + Accrual goal met, pending new cohort activation + + + + + + + + + + Loss of funding. + + + + + + + + + + Withdrawn due to slow accrual + + + + + + + + + + unable to replace Fellow conducting the study who left institution in 2007 + + + + + + + + + + Enrollment is temporarily paused to allow other studies to be conducted and may resume in the future. This is not a suspension of IRB approval. + + + + + + + + + + Research cancelled + + + + + + + + + + Study is withdrawn due to no enrollment, due to COVID pandemic. + + + + + + + + + + No IND submitted to the FDA + + + + + + + + + + Not approved by CMS + + + + + + + + + + Funding ended + + + + + + + + + + Sponsor the return rights of the compound to the collaboration partner for further clinical development + + + + + + + + + + classified by the IRB as non human subjects research + + + + + + + + + + The principal investigator left the center in 2016. + + + + + + + + + + Very slow recruitment - only 3 patients randomised + + + + + + + + + + No longer pursuing study at our site. + + + + + + + + + + No recruitment was achievable + + + + + + + + + + By recommendation from the Data and safety monitoring board + + + + + + + + + + Failure to recruit sufficient numbers due to the pandemic + + + + + + + + + + Study terminated due to potential safety concerns in combination with platinum-based therapies + + + + + + + + + + The intervention (PulsePoint application) could not be implemented in Toronto as planned + + + + + + + + + + This study was suspended because there is no more funds to complete the study. + + + + + + + + + + Clinical workflow was too high + + + + + + + + + + no participants enrolled + + + + + + + + + + Awaiting results from sub analysis to decide if study continuesé + + + + + + + + + + There was a delay in getting protocol approvals and hence the study would not be completed in time. + + + + + + + + + + MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years. + + + + + + + + + + For business reasons + + + + + + + + + + The app was not completed in time to conduct a clinical trial on it within the funding grant's award period + + + + + + + + + + Pending COVID-19 pandemic pending product development + + + + + + + + + + Change in staffing and not able to do study + + + + + + + + + + Funding + + + + + + + + + + lack of viability + + + + + + + + + + COVID shutdown + + + + + + + + + + Termination due to lack of adequate enrollment + + + + + + + + + + Decision to not proceed with study. + + + + + + + + + + Technical problems + + + + + + + + + + We will not be pursuing this study. + + + + + + + + + + Principle Investigator as left government service + + + + + + + + + + Terminated for lack of enrollment + + + + + + + + + + Poor recruitment + + + + + + + + + + Because the investigator's workplace and department have been changed, this study cannot be carried out. + + + + + + + + + + No adequate funding + + + + + + + + + + This study is terminated due to COVID-19 pandemic + + + + + + + + + + Study was conducted to fulfill a post marketing commitment (PMC 6). FDA acknowledged fulfillment of PMC. + + + + + + + + + + Low patient recruitment + + + + + + + + + + PI leaving institution: Will not continue study. + + + + + + + + + + Business Decision No Safety Or Efficacy Concerns. (See below) + + + + + + + + + + Study not started + + + + + + + + + + Medication removed from the U.S. market by the The Food and Drug Administration + + + + + + + + + + no funding to purchase study device + + + + + + + + + + Preliminary analyses of data indicated study should be terminated for futility + + + + + + + + + + Face-to-face appointments, which were required by the IRB for suicide risk evaluation, were suspended by the IRB during the COVID-19 pandemic. During this pause, the PI left the institution. Thus, all study activities were terminated. + + + + + + + + + + Other - Stage 1 has met accrual + + + + + + + + + + Lack of funds + + + + + + + + + + Lack of funding + + + + + + + + + + low recruitment rate + + + + + + + + + + toxicity + + + + + + + + + + Short of supply of fibrin glue + + + + + + + + + + terminated due to lack of enrollment + + + + + + + + + + Could not find interested researchers/clinicians to complete study protocol. + + + + + + + + + + Changes in availability of study personnel + + + + + + + + + + Study withdrawn. No participants enrolled. + + + + + + + + + + No patients + + + + + + + + + + At interim analysis the study did not meet the response criteria to continue + + + + + + + + + + The study did not receive anticipated funding and therefore never opened to enrollment. The study was never submitted to the IRB for approval since the funding failed. + + + + + + + + + + for inability to enroll subjects. + + + + + + + + + + DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates + + + + + + + + + + No study population in Mexico (H1N1). Study withdrawn from IRB consideration. + + + + + + + + + + Administrative reasons, and did not meet sample size requirements + + + + + + + + + + Never started enrollment due to logistics. + + + + + + + + + + No accrual. + + + + + + + + + + Lack of recruitment due to low acceptance of the control arm. + + + + + + + + + + Sponsor decision based on portfolio prioritization + + + + + + + + + + Difficult enrollment, no subjects identified to enroll + + + + + + + + + + Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency + + + + + + + + + + The study was not able to enroll any eligible subjects. + + + + + + + + + + This study was canceled for operational reasons. + + + + + + + + + + Slow accrual + + + + + + + + + + This is not a human subject's study. Protocol registered in error. This protocol studied nursing homes as a unit. + + + + + + + + + + Lack of recruitment + + + + + + + + + + administrative hurdles + + + + + + + + + + FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds + + + + + + + + + + Due to a pre-specified imbalance of deaths between treatment groups, the DSMB recommended early termination of the trial + + + + + + + + + + Insufficient Accrual + + + + + + + + + + Study closed due to lack of enrollment + + + + + + + + + + No patient has never been included in the trial + + + + + + + + + + Lack of funding + + + + + + + + + + no recruitment on time + + + + + + + + + + FDA will not authorize COVID-19 Ab tests for use over-the-counter. + + + + + + + + + + Sponsor is focusing on studies which can enable registration of duvelisib + + + + + + + + + + Problems recruiting patients (not willing, travel time, no respons) + + + + + + + + + + lack of inclusions + + + + + + + + + + Pending needed additional funding/resources + + + + + + + + + + Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible. + + + + + + + + + + insufficient recruitment + + + + + + + + + + Not able to find enough eligible patients (200) in last 4 years. + + + + + + + + + + Slow recruitment, lack of continued funding + + + + + + + + + + Toxicity + + + + + + + + + + low recruitment rate + + + + + + + + + + Slow/insufficient accrual and investigators have left the study. + + + + + + + + + + Corporate Decision + + + + + + + + + + Very slow recruitment of patients and the current COVID-19 pandemic situation. + + + + + + + + + + Drug development suspended by current holder of IND + + + + + + + + + + Withdrawn by PI + + + + + + + + + + Subject Recruitment + + + + + + + + + + If </= 5 of the initial 18 patients had a CR, the study would be stopped. Only 5 patients (21%) of 24 enrolled patients had a CR so the study was terminated. + + + + + + + + + + We did not get funding to develop the clinical trial. + + + + + + + + + + Pairing D-Cycloserine with Clozapine was found to worsen negative side effects in patients with Schizophrenia, so the study was suspended. + + + + + + + + + + Slow recruitment + + + + + + + + + + Terminated by Sponsor: see details below + + + + + + + + + + Recruitment problems (especially for chronic migraine patients) + + + + + + + + + + PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed + + + + + + + + + + Study was completed + + + + + + + + + + Development of BAY1000394 has been terminated by Bayer. + + + + + + + + + + A pilot study was negative. + + + + + + + + + + Update to clinical strategy - COVID impact + + + + + + + + + + Not enough patient + + + + + + + + + + No participants enrolled + + + + + + + + + + Study terminated due to low accrual and change in research focus. + + + + + + + + + + Insufficient funding to complete total projected enrollment + + + + + + + + + + Harvard University dining workers went on strike, we hope to relaunch in Fall 2017. + + + + + + + + + + due to sample problem + + + + + + + + + + Insufficient recruited participants due to a lack of collaborating study centers + + + + + + + + + + No recruitment + + + + + + + + + + Key personnel moving out + + + + + + + + + + we didn't have any patient + + + + + + + + + + Study conduct does not meet corporate objectives of sponsor + + + + + + + + + + Sequencing completed early + + + + + + + + + + Difficulty in enrolling subjects and transporting scope for sterilization + + + + + + + + + + Lack of MR scanning capacity + + + + + + + + + + stopped for futility + + + + + + + + + + lack of activity, Primary researcher moved to another institution + + + + + + + + + + Part1,double blind portion of the trial did not meet the primary end points + + + + + + + + + + DePuy discontinued this product in 4Q 2009.At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study. + + + + + + + + + + Due to a change in the development program, the study was closed prematurely. + + + + + + + + + + Study was terminated prior to full enrollment + + + + + + + + + + Study has been cancelled and it has not been initiated. + + + + + + + + + + Company focused on other clinical programs + + + + + + + + + + Phase I completed. Phase II is cancelled. + + + + + + + + + + Interim data analysis indicated too many variables prevented the ability to drawn conclusive evidence the devices affected falls. + + + + + + + + + + Study suspended and subsequently terminated due to Pandemic + + + + + + + + + + COVID pandemic + + + + + + + + + + Interim analysis also showed a lack of benefit in the experimental arm. + + + + + + + + + + Accrual too slow grant renewal unlikely AAI as effective as BiV in Phase III + + + + + + + + + + Slow recruitment + + + + + + + + + + Not able to get enough participants + + + + + + + + + + Interim Assessment: Lack of Efficacy + + + + + + + + + + no enrollment + + + + + + + + + + IDSMB recommendation + + + + + + + + + + Slow accrual + + + + + + + + + + Technical issues preventing recruitment. + + + + + + + + + + Low enrolment + + + + + + + + + + Study stopped due to early stopping rule + + + + + + + + + + PI change, hospital change and covid -19 caused lost-to-follow up of most of the subjects + + + + + + + + + + Study terminated due to insufficient enrollment + + + + + + + + + + No more funding support for additional procedures + + + + + + + + + + Life shirt technology no longer available + + + + + + + + + + Funding terminated + + + + + + + + + + We will not initiate recruitment for this protocol due to lack of funding to support this placebo-controlled trial. + + + + + + + + + + Due to concern for high systemic drug levels that could exceed levels in toxicology studies. + + + + + + + + + + Trial Logistics + + + + + + + + + + The study has been terminated due to difficulties in gathering the patient samples. + + + + + + + + + + low enrollment r/t requirement of prior treatment with denileukin diftitox + + + + + + + + + + Study is on hold until pilot study is completed + + + + + + + + + + The study was terminated early as the goal of determining a safe and efficacious dose for further development for the treatment of VMS was not met + + + + + + + + + + The study was not IRB approved and there were anticipated challenges in recruiting participants. + + + + + + + + + + Lack of enrollment + + + + + + + + + + Due to recent findings relating MRI contrast to nephrogenic systemic fibrosis + + + + + + + + + + Initiating a new study with revised Statistics. + + + + + + + + + + covid + + + + + + + + + + The trial was terminated because of inability to recruit the needed number of participants + + + + + + + + + + primary endpoint missed + + + + + + + + + + Study completed + + + + + + + + + + Intermediate analysis + + + + + + + + + + Administratively complete. + + + + + + + + + + Doxil Shortage + + + + + + + + + + Due to Low Accrual + + + + + + + + + + Slow accrual + + + + + + + + + + The study was discontinued prematurely by the sponsor due to a lack of recruitment. + + + + + + + + + + Study was stopped to pursue a new treatment plan with a new study. + + + + + + + + + + Difficulty enrolling patients as patients wanted articulating spacers. + + + + + + + + + + Study was stopped because of ineffectiveness of one investigated Drug + + + + + + + + + + Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame. + + + + + + + + + + Adverse event + + + + + + + + + + The cytokines in the samples were undetectable. + + + + + + + + + + Due to insurance non-payment, no subjects were enrolled. + + + + + + + + + + Insufficient clinical activity + + + + + + + + + + Treatment standard has changed. + + + + + + + + + + Business objectives have changed. + + + + + + + + + + The principal investigator left the hospital + + + + + + + + + + slow accrual + + + + + + + + + + Currently revieweing slow inclusion rate due to patients operated before intervention is implementable + + + + + + + + + + Support funding of the regional health authority stopped + + + + + + + + + + Investigator discretion due to lack of efficacy in three subjects enrolled + + + + + + + + + + Closed due to funding and never enrolled a subject + + + + + + + + + + Study objectives met + + + + + + + + + + The complexity of the study and the recent slow down situation hampered the ability to recruit CAD patients therefore the study has been terminated. + + + + + + + + + + slow recruitment + + + + + + + + + + Funding + + + + + + + + + + See termination reason in detailed description. + + + + + + + + + + Due to slow accrual + + + + + + + + + + Low inclusion rate + + + + + + + + + + Lack of patient availability and expiration of study drug + + + + + + + + + + Change in company priorities + + + + + + + + + + slow accrual + + + + + + + + + + Difficulty with patient recruitment + + + + + + + + + + Low enrollment due to the stringent enrollment criteria. Unable to answer study questions + + + + + + + + + + Insufficient staff for measurement assessments + + + + + + + + + + Logistic reasons, financial contrastraints + + + + + + + + + + Inability to enroll subjects. + + + + + + + + + + The trial was prematurely terminated due to low recruitment + + + + + + + + + + Data difficult to collect due to the COVID-19 pandemic. + + + + + + + + + + Terminated due to lack of funding + + + + + + + + + + Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation + + + + + + + + + + Recruitment difficulties + + + + + + + + + + Lack of enrollment and commercial availability of drug + + + + + + + + + + With 2078 patients, a statistical stopping boundary has now been crossed + + + + + + + + + + The study was stopped early due to successfully meeting the primary endpoint + + + + + + + + + + this is an observational project and doesn't not meet any of the four criteria required for listing on clinical trials.gov + + + + + + + + + + Low/inadequate rate of accrual. + + + + + + + + + + Lead Investigator no longer at Institution + + + + + + + + + + Principal Investigator decided not to move forward with the study + + + + + + + + + + No participants met eligibility requirements + + + + + + + + + + "Tapering doses" protocol arm was not effective for treatment retention outcome. + + + + + + + + + + Gathering information from the PI records to provide this response. + + + + + + + + + + per sponsor decision + + + + + + + + + + PI left institution + + + + + + + + + + Study is replaced by MI-CP198 per CPM. + + + + + + + + + + This application needs further attention in terms of FDA approval and will be reassigned under a different trial number later. + + + + + + + + + + it was not possible to recruit any patient in the study + + + + + + + + + + Because it seemed not of interest based on the current literature + + + + + + + + + + Lack of funding + + + + + + + + + + Did not want to enroll and proceed with this study concept. + + + + + + + + + + Vaccine sponsor ceased operations. + + + + + + + + + + Sponsor elected not to continue with study. + + + + + + + + + + Poor recruiting + + + + + + + + + + Lack of funding. Changed design. + + + + + + + + + + DSMB + + + + + + + + + + low accrual + + + + + + + + + + New studies were reporting that sutures are beneficial, hindering the possibility of enrollment. + + + + + + + + + + Study follow-up activities affected by COVID-19 + + + + + + + + + + Nexis Vision was unable to provide the shields to continue with the study. + + + + + + + + + + Logistically recruitment was not applicable after trial of a few patients + + + + + + + + + + Study experienced delays due to site recruitment. Funder terminated contract. + + + + + + + + + + It is difficult to recruit partcipants under COVID-19. + + + + + + + + + + Lead Investigator no longer with institution + + + + + + + + + + This study did not receive funding + + + + + + + + + + not funded + + + + + + + + + + Emergence of FOLFIRINOX and slow recruitment + + + + + + + + + + Slow accrual + + + + + + + + + + 1. enrollment slower than anticipated; 2. FDA approval of droxidopa so no longer need to treat patients on research basis; 3. personnel who were primarily responsible for the study are no longer at Vanderbilt. + + + + + + + + + + Modifying the clinnicaltrials + + + + + + + + + + COVID + + + + + + + + + + Business decision + + + + + + + + + + At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data. + + + + + + + + + + Administratively terminated. + + + + + + + + + + logistic problems + + + + + + + + + + Covid-19 Pandemic + + + + + + + + + + Due to slow recruitment and a delay in reaching the recruitment target. + + + + + + + + + + Most potential subjects had already been prescribed Cymbalta. + + + + + + + + + + Funding source unavailable + + + + + + + + + + IRB approval withheld + + + + + + + + + + See termination reason in detailed description. + + + + + + + + + + The decision of terminate the study was reached due to difficulties surrounding recruitment and enrollment of subjects since the inception of the study. + + + + + + + + + + Lack of funding + + + + + + + + + + PI left institution + + + + + + + + + + Preclinical finding + + + + + + + + + + Due to significant changes in investigational and clinical practice landscape of frontline advanced gastric cancer, which challenged viability of trial and increased use of modified chemotherapeutic triplets led to slow participant accrual in study. + + + + + + + + + + Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169. + + + + + + + + + + Did not meet interim stopping criteria for continuation to the second stage. + + + + + + + + + + slow accrual + + + + + + + + + + No patient accrual + + + + + + + + + + Canceled + + + + + + + + + + Protocol was stopped due to the safety issue in Global + + + + + + + + + + Change in staffing and budget due to Covid-19 + + + + + + + + + + The computer is crushed and all data is lost (IT was not able to recover it. Last data was collected 6.17.14) + + + + + + + + + + Insufficient patient accrual + + + + + + + + + + Negative Efficacy Results from the recently completed Phase 3 study 104-201506 + + + + + + + + + + No subjects were enrolled in this study. Funding ran out. + + + + + + + + + + difficult to enroll, Pi decision to closed + + + + + + + + + + low incidence of primary endpoint + + + + + + + + + + Insufficient recruitment, too much selective inclusion criteria, feasibility problems + + + + + + + + + + 1) A delay in obtaining immunoassays to measure serum neopterin 2)altered relevance of the expected experimental results to clinical practice + + + + + + + + + + Recommended by DMEC. Poor recruitment, changes in current clinical management of Vit D deficiency. Research question no longer relevant + + + + + + + + + + We were unable to secure funding for the triaging experiment. The participatory design process ran its course as intended. + + + + + + + + + + Business decision. + + + + + + + + + + Slow accrual + + + + + + + + + + Closed per Data Monitoring Committee due to lack of efficacy + + + + + + + + + + Amgen Administrative Decision - termination of LTFU + + + + + + + + + + The study was terminated per PI decision. + + + + + + + + + + Slow Accrual + + + + + + + + + + Due to the outbreak of the SARS-CoV-2 pandemic in Argentina and the lack of information about the potential risks of contamination from extubation and aerosolization, we stopped recruiting patients before achieving the predefined sample size. + + + + + + + + + + Strategy change + + + + + + + + + + termination of the study due to the slowness of the recruitment activity, according to the contract signed with the Sponsor + + + + + + + + + + Project was withdrawn and never began at Loyola University Medical Center. + + + + + + + + + + Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape + + + + + + + + + + Inadequate number of patients, lack of funding + + + + + + + + + + Due to insufficient patient recruitment and lack of funding + + + + + + + + + + Incyte has suspended development of the compound. + + + + + + + + + + Did not achieve enrollment goal and decided to terminate early + + + + + + + + + + Study is withdrawn before recruting participants, new trial will be multi centre, sponsored by different organisation. + + + + + + + + + + Due to SARS-CoV-2 pandemic research restrictions placed by university, unable to collect data at this time + + + + + + + + + + Inadequate eligible subjects to expect sufficient numbers to analyse outcomes. + + + + + + + + + + Terminated (halted prematurely) due to COVID-19. + + + + + + + + + + PI LEFT THE DEPARTMENT + + + + + + + + + + The total number of patients has been reached. + + + + + + + + + + Nitric Oxide analyzer not functioning properly + + + + + + + + + + Study design has changed. + + + + + + + + + + Recruitment was at a standstill. We are currently preparing our results for publication. + + + + + + + + + + Early termination due to lesser accrual, and data analysis not done. + + + + + + + + + + The study was terminated early based on the results of a planned interim analysis. + + + + + + + + + + Main bedrest study moved to Texas. No enrollment at Cleveland Clinic. + + + + + + + + + + Enrollment + + + + + + + + + + No enrollement and covid + + + + + + + + + + Low accrual/Loss of funding + + + + + + + + + + Study C11-01 started + + + + + + + + + + Funding ended + + + + + + + + + + Technical difficulties + + + + + + + + + + Lack of funds + + + + + + + + + + Per Group Chair: This study will not move forward. + + + + + + + + + + Co-PI left institution, PI not pursuing + + + + + + + + + + No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients. + + + + + + + + + + This was never a clinical trial and should never have been approved. + + + + + + + + + + Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.) + + + + + + + + + + The company will design a new study + + + + + + + + + + Lack of available patients + + + + + + + + + + Stopping rule-acute rejection threshold-was met based on local biopsy results + + + + + + + + + + Administratively complete. + + + + + + + + + + Study did not meet pre-specified objectives. + + + + + + + + + + Study terminated because of COVID19 pandemics. + + + + + + + + + + lack of inclusion and prophylaxy plateform being free to use for everyone in septembre 2016 + + + + + + + + + + A conflicting project required the same sample for a different purpose. + + + + + + + + + + Due to on-going enrollment challenges + + + + + + + + + + French Agency for the Safety of Health Products refusal + + + + + + + + + + unable to recruit patients + + + + + + + + + + Poor enrollment + + + + + + + + + + Funding issues + + + + + + + + + + Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation. + + + + + + + + + + Re-prioritization lead to study cancellation. + + + + + + + + + + Development in prostate cancer indication halted + + + + + + + + + + No funding at the current time. + + + + + + + + + + Investigator Decision due to insufficient accrual. + + + + + + + + + + New department chairman instructed PI to discontinue study. + + + + + + + + + + This potential study was held up at the level of the FDA as they wouldn't approve and IND for the dose of vitamin C we wanted to use. + + + + + + + + + + IDMC recommendation + + + + + + + + + + Protocol transitioned to standard of care, no funding available to support research work + + + + + + + + + + 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns. + + + + + + + + + + Insufficient number of patient records met inclusion criteria + + + + + + + + + + Due to limited population of research participants. + + + + + + + + + + lack of recruitment/patient population + + + + + + + + + + Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early. + + + + + + + + + + Investigator decided not to pursue. + + + + + + + + + + The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn. + + + + + + + + + + Higher then expected Gr3 GU/GI toxicity + + + + + + + + + + No patients recruited + + + + + + + + + + This study was terminated early due to futility. + + + + + + + + + + Study was stopped for slow enrollment - only 2 patients, no evaluable results + + + + + + + + + + Funding source was terminated before enrollment of first subject + + + + + + + + + + Inability to safely recruit subjects during Covid pandemic + + + + + + + + + + study never started due to funding issues + + + + + + + + + + funding pending + + + + + + + + + + Study enrollment was halted due to slow accrual. + + + + + + + + + + No actual DM + + + + + + + + + + Study halted prematurely, prior to enrollment of first participant, for strategic reasons + + + + + + + + + + Lack of patients + + + + + + + + + + Study never started, no subjects enrolled + + + + + + + + + + Interim analysis recommended terminating the study + + + + + + + + + + PI no longer at site. Data was not collected + + + + + + + + + + Due to Sorafenib became first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue to support + + + + + + + + + + not a required sutudy to be posted + + + + + + + + + + Poorly recruiting + + + + + + + + + + Company decision + + + + + + + + + + Saliva testing was not sensitive enough to correctly identify high risk patients + + + + + + + + + + PI Left Institution prior to reaching accrual goal and analyzing data. + + + + + + + + + + Financial reason + + + + + + + + + + This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151. + + + + + + + + + + Lack of enrollment + + + + + + + + + + insufficient recruitment + + + + + + + + + + paused because of Covid + + + + + + + + + + Slow accrual + + + + + + + + + + Project Cancelled + + + + + + + + + + B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study B5301012 was terminated in 1/6/2015. No safety concerns identified. + + + + + + + + + + Clinical evaluation plan outdated and obsolete due to altered clinical routine + + + + + + + + + + See termination reason in detailed description. + + + + + + + + + + Prematurely closed due to ongoing challenging enrollment requirements. + + + + + + + + + + The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study. + + + + + + + + + + PI Left Institution + + + + + + + + + + This study was stopped before any subjects were treated, consequently there are no results for the study. + + + + + + + + + + Terminated for futility by sponsor after a pre-planned interim review of data + + + + + + + + + + The study was closed after > 1 year of inactivity. + + + + + + + + + + Slow accrual + + + + + + + + + + We planed to study later + + + + + + + + + + Recruitment and feasability issues + + + + + + + + + + No patients enrolled due to change in standard practice + + + + + + + + + + pending expiration of the supply of study agent. + + + + + + + + + + Interim futility analyses identified a lack of SYNB1020 efficacy. + + + + + + + + + + No more potentiel patients for study + + + + + + + + + + Study withdrawn due to lack of available patients meeting entry criteria + + + + + + + + + + Business decision + + + + + + + + + + Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant + + + + + + + + + + Unable to enroll eligible participants + + + + + + + + + + No enrollment + + + + + + + + + + Practice patterns with pemetrexed have evolved. + + + + + + + + + + IND has been closed. + + + + + + + + + + Lack of funding + + + + + + + + + + Replaced by another protocol + + + + + + + + + + Reformulation of study drug to help reduce the pill burden as higher doses are evaluated. + + + + + + + + + + It became unlikely to achieve the study objective of 50% reduction over published inhibitor rates. The Data Monitoring Committee supported this decision. + + + + + + + + + + the chosen intervention was obviously ineffective + + + + + + + + + + Recruitment not satisfactory + + + + + + + + + + Low accrual + + + + + + + + + + Change in referral pattern changed the population we were studying + + + + + + + + + + New departmental administration, loss of key study faculty + + + + + + + + + + Funding withdrawn due to delay in FDA IND submission + + + + + + + + + + Funding + + + + + + + + + + COVID-19 Pandemic interfered with Pt recruitment + + + + + + + + + + Study never approved by IRB or initiated + + + + + + + + + + an interim analysis was provided for in the protocol. The results are unsatisfactory + + + + + + + + + + Could not be completed due to technology problems and cost constraints + + + + + + + + + + The PI left the university + + + + + + + + + + Design of the study device will be modified + + + + + + + + + + safety issues (toxicity) + + + + + + + + + + Sponsor terminated the study. + + + + + + + + + + Interim analysis found study had achieved primary objective + + + + + + + + + + Use of bupropion with counseling works better to help patients quit smoking. + + + + + + + + + + funding unavailable + + + + + + + + + + Never funded + + + + + + + + + + Study was terminated due to lack of interest from subjects and no funding, only 1 subject signed consent but did not participate. + + + + + + + + + + Unable to recruit subjects - unworkable + + + + + + + + + + Business Decision + + + + + + + + + + Sponsor's decision + + + + + + + + + + Study was closed and reopened as NCT01717391 + + + + + + + + + + Business decision to end study due to limited enrollment and study population + + + + + + + + + + Study was withdrawn due issuses related to the science + + + + + + + + + + Person working on the trial left + + + + + + + + + + Slow recruitment + + + + + + + + + + low accrual + + + + + + + + + + lack of recruitment + + + + + + + + + + Business Decision + + + + + + + + + + Large and sustained difference in pregnancy rate + + + + + + + + + + insufficient recruitment + + + + + + + + + + PI has requested for this study be closed due to technical issues + + + + + + + + + + The study never started + + + + + + + + + + Stopped for one complication event (arterial occlusion) + + + + + + + + + + COVID-19 pandemic + + + + + + + + + + Treatment Ineffective + + + + + + + + + + Problem with drug supply + + + + + + + + + + Inadequate recruitment + + + + + + + + + + The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile. + + + + + + + + + + Researchers left institution + + + + + + + + + + Study never initiated + + + + + + + + + + PI no longer at facility. + + + + + + + + + + Due to low enrollment. + + + + + + + + + + Study objectives met + + + + + + + + + + Site did not want to pursue study + + + + + + + + + + Study terminated by the Sponsor + + + + + + + + + + Investigator's decision + + + + + + + + + + Appropriate devices for fetal heart rate monitoring were not available. + + + + + + + + + + Lacking of funding + + + + + + + + + + Limitaiotn of financial support + + + + + + + + + + Infusion reactions during re-induction cycles after a period of no treatment. Please see "Purpose" section. + + + + + + + + + + Lack of budget + + + + + + + + + + competing protocol + + + + + + + + + + Poor accrual + + + + + + + + + + FDA recommendation + + + + + + + + + + Business decision + + + + + + + + + + The investigators were not able to get grant funding for this study. + + + + + + + + + + Difficulty with recruiting + + + + + + + + + + IRB not approved + + + + + + + + + + Terminated: Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint. + + + + + + + + + + This study has closed to accrual early due to slow accrual. + + + + + + + + + + Vaccines safe but not immunogenic in 8 participants trial closed to further recruitment by the protocol steering committee & DSMB. + + + + + + + + + + Study classified as out of scope by the Ethics Committee (not a project involving human person). + + + + + + + + + + Slow Enrollment + + + + + + + + + + Scheduled Interim Monitoring + + + + + + + + + + Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place. + + + + + + + + + + Enrollment held for toxicity evaluation then closed due to competing trial + + + + + + + + + + P. I. left the Institution. Study never opened + + + + + + + + + + Failure to recruit people with very late onset schizophrenia like psychosis + + + + + + + + + + See statement in Detailed Description. + + + + + + + + + + Funding + + + + + + + + + + It's no longer feasible to continue to recruit patients into the study as severe recruitment difficulties have been experienced since the study start + + + + + + + + + + No participaints enrolled + + + + + + + + + + Terminated early by Sponsor for business reasons unrelated to safety. + + + + + + + + + + PI leaving + + + + + + + + + + recruitment problem + + + + + + + + + + Slow to accrue, lack of qualified participants + + + + + + + + + + no sponsor support + + + + + + + + + + Study halted prematurely and will not resume. Subjects were seen until February 2017 + + + + + + + + + + Therapy for carotid disease has recently changed. Carotid stenting is now restricted to high risk patients that are not eligible for the study. + + + + + + + + + + Poor enrollment + + + + + + + + + + Resource and time constraints were encountered by product manufacturer and study team. + + + + + + + + + + prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ + + + + + + + + + + Our study stopped before it could begin because of the Covid-19 pandemic. We revised the study so that it could be performed virtually, but the revised study isn't a clinical trial. + + + + + + + + + + Lack of approval and funding from company + + + + + + + + + + Replaced by another study. + + + + + + + + + + Problems recruiting and retaining volunteer research personnel to assist with the recruitment of subjects and the study procedures + + + + + + + + + + no funding + + + + + + + + + + Due to the low rate of primary endpoint events experienced in the study to date + + + + + + + + + + Closed by PI prior to approval + + + + + + + + + + PI no longer wanted to do the study + + + + + + + + + + No significant change for the primary objective at 12 months + + + + + + + + + + Lower recruitment rate than expected + + + + + + + + + + recruitment + + + + + + + + + + PI + + + + + + + + + + lack of accrual + + + + + + + + + + lack of funding + + + + + + + + + + insufficient enrollment + + + + + + + + + + The study was closed due to poor accrual and because of competing protocols. + + + + + + + + + + The quality of study was seriously affected by the COVID-19, so it was decided to suspend the trial and restart it at the right time. + + + + + + + + + + Specimens are now collected through the BRS protocol. + + + + + + + + + + No funding for the project + + + + + + + + + + Resource constraints at participating sites + + + + + + + + + + Alternative data published + + + + + + + + + + insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased. + + + + + + + + + + Trial funding no longer available. + + + + + + + + + + This Phase I study was permanently closed to patient accrual on February 23, 2011, due to the discontinuation of support from MERCK. + + + + + + + + + + Lack of enrollment + + + + + + + + + + COVID-19 Impacted Service Delivery and Research Infrastructure + + + + + + + + + + Other - Clinical development of the agent has been discontinued + + + + + + + + + + Based on preliminary parent study results + + + + + + + + + + lack of effectiveness + + + + + + + + + + Novartis terminated all projects involving aliskiren. Findings of the DMC overseeing the ALTITUDE clinical trial found a higher incidence of adverse events. + + + + + + + + + + Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app. + + + + + + + + + + Trial closed due to low accrual + + + + + + + + + + low inclusion rate + + + + + + + + + + Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out + + + + + + + + + + The IND was withdrawn. + + + + + + + + + + no longer interested in doing the study + + + + + + + + + + no participants enrolled + + + + + + + + + + no need to include more patients for analysis. 40 patients initially (36 actual) + + + + + + + + + + Due to slow recruitment and recent new published data + + + + + + + + + + Sponsor decision for business purposes + + + + + + + + + + Principal Investigator Left Institution + + + + + + + + + + Lack of time to enroll due to additional responsibilities of the PI and research coordinator. + + + + + + + + + + Unable to recruit participants for this study + + + + + + + + + + Due to recruiting issues + + + + + + + + + + Company suspended development of product. + + + + + + + + + + lack of funding + + + + + + + + + + Difficulty in purchasing reagents and receiving consent from the subject + + + + + + + + + + funding + + + + + + + + + + Manufacturer will not be supporting this study + + + + + + + + + + recruitment failure + + + + + + + + + + Failure to recruit + + + + + + + + + + Study was closed to enrollment before dose level one was completed. + + + + + + + + + + Subject recruitment unable to be completed due to study feasibility issues. + + + + + + + + + + No study population. No subjects enrolled. + + + + + + + + + + Sponsor terminated. No longer needed to support business need + + + + + + + + + + No patients were enrolled + + + + + + + + + + Sponsor decision + + + + + + + + + + Administratively complete. + + + + + + + + + + unable to recruit participants due to political issues + + + + + + + + + + Recruitment challenging: lack of suitable pts recruiting so soon after diagnosis competing studies. Funding ended despite extensions to grant. + + + + + + + + + + Administrative barriers + + + + + + + + + + not sufficiency recruitment + + + + + + + + + + Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility + + + + + + + + + + Unable to commence study due to closure of hospital department. + + + + + + + + + + Seton IRB administratively closed this study on January 6, 2017 + + + + + + + + + + Temporarily suspended due to equipment issues + + + + + + + + + + Strategic considerations + + + + + + + + + + Study terminated due to low subject enrollment. Safety results consistent with product label. + + + + + + + + + + No inclusion + + + + + + + + + + PI left institution. Protocol not submitted to IRB, contract not executed, and study was not done. + + + + + + + + + + Study did not meet its primary objective + + + + + + + + + + Changes to study personnel. + + + + + + + + + + Unable to find eligible subjects- study closed + + + + + + + + + + low accrual + + + + + + + + + + The DSMB committee recommended closing the trial because of the COVID-19 risk in this "at-risk" oGVHD population if they came for study visits. + + + + + + + + + + unable to enroll participants who meet the criteria + + + + + + + + + + Terminated: higher rate of acute rejection in the Cyclosporin A group + + + + + + + + + + No enrollment. + + + + + + + + + + Lack of funding + + + + + + + + + + The trial was terminated due to investigator's decision + + + + + + + + + + Sponsor's decision + + + + + + + + + + This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns. + + + + + + + + + + The study was terminated approximately 6 months earlier than planned because 227 subjects (59% more than anticipated) had already completed 10-Year Visits due to lower than expected attrition + + + + + + + + + + Laproscopic procedure not offered at this time; will not be offered for the foreseeable, thus we are unable to randomize participants between the two arms. + + + + + + + + + + Challenges with recruitment + + + + + + + + + + No funding obtained + + + + + + + + + + Early termination due to a suspension of financial support + + + + + + + + + + the PI is no longer work at Hadassah + + + + + + + + + + Enrollment challenges + + + + + + + + + + Due to slow accrual + + + + + + + + + + Low recruitment + + + + + + + + + + funding was not secured + + + + + + + + + + Terminated due to a distribution issue with the trial medication + + + + + + + + + + Slow Accrual + + + + + + + + + + - Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia. + + + + + + + + + + Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases. + + + + + + + + + + Lack of support staff + + + + + + + + + + End in funding + + + + + + + + + + poor accrual + + + + + + + + + + The COVID-19 pandemic increased hospital pressure and suspended hospital visits, making it impossible to continue with recruitment. The project has been terminated. + + + + + + + + + + no fund + + + + + + + + + + The study was prematurely terminated due to insufficient recruitment. + + + + + + + + + + the trial was discontinued for legislative reasons. + + + + + + + + + + loss of funding + + + + + + + + + + Sponsor withdrew funding + + + + + + + + + + Product discontinued in November 2014 + + + + + + + + + + Study complexity, low study recruitment + + + + + + + + + + The study was terminated for business reasons. + + + + + + + + + + recruiting or enrolling participants has halted prematurely and will not resume participants are no longer being examined or treated + + + + + + + + + + Study not feasible-Not able to enroll the patient population + + + + + + + + + + Original PI left institution. + + + + + + + + + + Common comorbidities of Veterans precluded sufficient recruitment and enrollment. + + + + + + + + + + Principal Investigator withdrew from the study. + + + + + + + + + + Sponsor decision. + + + + + + + + + + Lack of patient enrollment + + + + + + + + + + May 2007: No annual renewal + + + + + + + + + + recruitment efforts did not result in a sufficient number of patients + + + + + + + + + + Low recruitment rates and timeline viability analysis. + + + + + + + + + + Not feasible to recruit and follow-up subjects due to the pandemic + + + + + + + + + + Study site has terminated the study due to the complexity of the study + + + + + + + + + + We found out that there is another study on the same issue + + + + + + + + + + Slow Enrolling + + + + + + + + + + No funding available. + + + + + + + + + + did not apply for ethics renewal + + + + + + + + + + Replaced by new study in progress + + + + + + + + + + Limited participants for enrollment + + + + + + + + + + FDA released from conducting + + + + + + + + + + Funding ended + + + + + + + + + + Principal Investigator moved to Jacksonville, FL campus. + + + + + + + + + + Zero Patients met criteria + + + + + + + + + + The study was terminated early on 03/09/2022 due to low accrual during the COVID-19 pandemic. + + + + + + + + + + inability to meet enrollment goals in this subject population + + + + + + + + + + Strategic decision + + + + + + + + + + Planned interim analysis demonstrated futility of intervention + + + + + + + + + + no one enrolled PI left institution + + + + + + + + + + Study was not able to be completed, no results analyzed. + + + + + + + + + + Awaiting verification of assay + + + + + + + + + + It was difficult to recruit patients to get the appropriate sample size. + + + + + + + + + + PI has left the study institution. + + + + + + + + + + Lack of Funding + + + + + + + + + + Study ended due to difficulties in recruitment and low enrollment. + + + + + + + + + + Injection site reaction met protocol-defined stopping criteria. + + + + + + + + + + Other - Protocol moved to Disapproved + + + + + + + + + + The researchers were unable to answer the study question by utilizing the insurance claims database. + + + + + + + + + + The sponsor terminated funding for the study. + + + + + + + + + + Unable to find adequate funding + + + + + + + + + + Lack of accrual. We were unable to enroll enough participants to have meaningful results. + + + + + + + + + + Lack of funding + + + + + + + + + + Study not funded + + + + + + + + + + The Sponsor's decision to terminate the SBC-103 program was reached after review of the data from all interventional clinical studies of SBC-103. + + + + + + + + + + Lack of Accrual + + + + + + + + + + Trial was stopped due to difficult enrolment + + + + + + + + + + Study was not conducted, no subjects recruited. + + + + + + + + + + Pentostatin/alemtuzumab regimen had greater risk of graft failure. + + + + + + + + + + did not receive funding + + + + + + + + + + insufficient number of inclusion + + + + + + + + + + Enrollment closed + + + + + + + + + + Futility boundary at interim analysis not met + + + + + + + + + + issue concerning safety of elastography during pregnancy + + + + + + + + + + CHU Lyon will join as a participating center (and as national French coordinator) as a part of the BEV-IP study ongoing study EudraCT-number 2014-004257-14. + + + + + + + + + + The preliminary result didn't show any benefit. + + + + + + + + + + slow accrual and financial resource limitation + + + + + + + + + + Study design is not reasonable and sponsor decided to terminate the study. No patient enrolled by now + + + + + + + + + + physician decision to stop study early due to low enrollment + + + + + + + + + + Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time. + + + + + + + + + + The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods + + + + + + + + + + because of low rate recruitment and the inability to reach the target expected + + + + + + + + + + Not enough patients + + + + + + + + + + Low recruitment in intervention study. Baseline data published. + + + + + + + + + + Study stopped due to product discontinuation by manufacturer + + + + + + + + + + Lack of enrollment + + + + + + + + + + Funding unavailable + + + + + + + + + + Study was terminated early do to a business decision by sponsor and lack of ability to recruit the needed number of participants. + + + + + + + + + + Designed a new modified/simplified protocol see NCT 03180489 + + + + + + + + + + Not enough inclusions. + + + + + + + + + + participants are no longer being examined or receiving intervention + + + + + + + + + + Per memo from study team + + + + + + + + + + Sponsor's clinical development strategy adjustment + + + + + + + + + + Business Decision + + + + + + + + + + There has been no unanimous approval by the investigators regarding the approval of the study protocol. Therefore, by mutual agreement, sponsor and investigators have taken the decision to withdraw the clinical study. + + + + + + + + + + Due to an imbalance in graft infections between groups. + + + + + + + + + + The study is out of date + + + + + + + + + + difficulty in recruiting subjects + + + + + + + + + + Study suspended because of safety reasons + + + + + + + + + + Low recruitment of participants for the study + + + + + + + + + + Due to COVID pandemic + + + + + + + + + + Primary Investigator left UT Southwestern and was not replaced. + + + + + + + + + + Administrative + + + + + + + + + + key investigator relocated. + + + + + + + + + + + + + + + + + + + + + + Data + + + + + + Sum - Safety/Efficacy issues + + + Sum - Enrollement/Accrual problems, + + + Sum - Pandemic/COVID19, + + + Sum - Funding problems, + + + Sum - Issue with sponsor/Principle Investigator/Company, + + + Sum - protocol change + + + Sum - Other operational challeng + + + Sum - Other study + + + Sum - Other challenge + + + Count - Marked + + + + + 29 + + + 62 + + + 11 + + + 18 + + + 39 + + + 8 + + + 17 + + + 7 + + + 21 + + + 199 + + + + + 14.57% + + + 31.16% + + + 5.53% + + + 9.05% + + + 19.60% + + + 4.02% + + + 8.54% + + + 3.52% + + + 10.55% + + + 100.00% + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + \ No newline at end of file