diff --git a/Paper/Main.tex b/Paper/Main.tex index 836e309..ba77a1b 100644 --- a/Paper/Main.tex +++ b/Paper/Main.tex @@ -46,13 +46,13 @@ completion of clinical trials\\ \small{Preliminary Draft}} %--------------------------------------------------------------- \subfile{sections/11_intro_and_lit} +%TODO: Remove this lit review section. +% \subfile{sections/05_LitReview} %--------------------------------------------------------------- -\section{Literature Review}\label{SEC:LiteratureReview} -%--------------------------------------------------------------- -\subfile{sections/05_LitReview} \section{Clincal Trial Background}\label{SEC:ClinicalTrials} +%--------------------------------------------------------------- \subfile{sections/12_clinical_trial_background} diff --git a/Paper/sections/10_CausalStory.tex b/Paper/sections/10_CausalStory.tex index 5ce5883..9fd97f7 100644 --- a/Paper/sections/10_CausalStory.tex +++ b/Paper/sections/10_CausalStory.tex @@ -50,7 +50,8 @@ safety and efficacy standards that the drug will be held too. For example, if a particular cancer is very deadly and does not respond well to current treatments, Phase I trials will enroll patients with that cancer, as opposed to the standard of enrolling healthy volunteers -\cite{commissioner_DrugDevelopment_2020} to establish safe dosages. +\cite{commissioner_drugdevelopmentprocess_2020} +to establish safe dosages. The trial is more likely to be terminated early if the drug is unsafe or has no discernabile effect, therefore termination depends in part on a compound-disease interaction. @@ -74,7 +75,7 @@ help the sponsor judge whether or not to continue the trial. Since Sep 27th, 2007 those who conduct clinical trials of FDA controlled drugs or devices on human subjects must register their trial at \url{ClinicalTrials.gov} -(\cite{noauthor_fdaaa_nodate}). +(\cite{anderson_fdadrugapproval_2022}). This involves submitting information on the expected enrollment and duration of trials, drugs or devices that will be used, treatment protocols and study arms, as well as contact information the trial sponsor and treatment sites. @@ -84,13 +85,13 @@ When starting a new trial, the required information must be submitted After the initial submission, the data is briefly reviewed for quality and then the trial record is published and the trial is assigned a National Clinical Trial (NCT) identifier. -\cite{noauthor_fdaaa_nodate}. +(\cite{anderson_fdadrugapproval_2022}). Each trial's record is updated periodically, including a final update that must occur within a year of completing the primary objective, although exceptions are available for trials related to drug approvals or for trials with secondary objectives that require further observation\footnote{This rule came into effect in 2017} -\cite{noauthor_fdaaa_nodate}. +(\cite{anderson_fdadrugapproval_2022}). Other than the requirements for the the first and last submissions, all other updates occur at the discresion of the trial sponsor. Because the ClinicalTrials.gov website serves as a central point of information diff --git a/Paper/sections/12_clinical_trial_background.tex b/Paper/sections/12_clinical_trial_background.tex index 7016d35..c750a2e 100644 --- a/Paper/sections/12_clinical_trial_background.tex +++ b/Paper/sections/12_clinical_trial_background.tex @@ -51,7 +51,9 @@ marked as ``Terminated'' on Note the information we obtain about the trial from the final status: ``Withdrawn'', ``Terminated'', or ``Completed''. -Although \cite{khm} describes a clinical failure due to safety or efficacy as a +Although +\cite{khmelnitskaya_competitionattritiondrug_2021} +describes a clinical failure due to safety or efficacy as a \textit{scientific} failure, it is better described as a compound failure. Discovering that a compound doesn't work as hoped is not a failure but the whole purpose of the clinical trials process.