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@ -196,7 +196,7 @@ Washington State University \\ % Your institution for the title page
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\item current status
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\item current status
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\end{itemize}
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\end{itemize}
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ClinicalTrials.gov also reports the ``history'' from previous
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ClinicalTrials.gov also reports the history from previous
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updates.
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updates.
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\end{frame}
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\end{frame}
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@ -216,7 +216,111 @@ Washington State University \\ % Your institution for the title page
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% - Introduce backdoor criterion
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% - Introduce backdoor criterion
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%--------------------------------
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%--------------------------------
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%-------------------------------
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\begin{frame}
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\frametitle{Framing my Questions}
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Two potential causes of trial termination include
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\begin{enumerate}
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\item Alternative (competitor) treatments exist
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\begin{itemize}
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\item reduces future profitability.
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\item reduces incentives to enroll as participants.
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\end{itemize}
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\item It can be difficult to recruit patients
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\begin{itemize}
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\item Are there few patients?
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\item Are potential participants choosing other alternatives?
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\end{itemize}
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\end{enumerate}
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Overall this can be described graphically as:
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INSERT IMAGE OF 4 NODES HERE
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Causal Identification: Backdoor Criterion}
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%Discuss the two different effects: total effect, direct effects
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\begin{columns}
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\begin{column}{0.5\textwidth}
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Total Effect of Competitors
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INSERT TOTAL EFFECT GRAPH
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\end{column}
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\begin{column}{0.5\textwidth}
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Direct Effects of Competitors and Enrollment
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INSERT DIRECT EFFECT GRAPH
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\end{column}
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\end{columns}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Rephrasing Questions}
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To rephrase my questions
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\begin{enumerate}
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\item How large is the total effect of increasing the number of competing drugs on completing clinical trials?
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\item How large is the direct effect of increasing the number of competing drugs on completing clincial trials?
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\end{enumerate}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Additional Concerns}
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%Confounders
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Of course, there are other confounding relationships
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\begin{enumerate}
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\item Population Effects
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\item Fundamental Safety and Efficacy of compound/dosage/route
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\end{enumerate}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Complete graph}
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%introduce backdoor criterion
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INSERT COMPLETE GRAPH HERE
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Causal Identification: Backdoor Criterion}
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%introduce backdoor criterion
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\cite{PEARLYYYY} developed a method of verifying causal identification from DAGs like the one I presented.
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Of particular interest is the rule called the Backdoor criterion:
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INSERT DESCRIPTION OF THE BACK DOOR CRITERION
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Sufficent Adjustment Set}
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%introduce backdoor criterion
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INSERT COMPLETE GRAPH HERE with adjustment set highlighted
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Sufficent Adjustment Set}
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%introduce backdoor criterion
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Thus the required adjustment set includes:
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\begin{itemize}
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\item Population Measures
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\item Safety and Efficacy Measures
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\item INSERT MORE
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\end{itemize}
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\end{frame}
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%-------------------------------
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%-------------------------------
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\begin{frame}
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\begin{frame}
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\frametitle{Questions?}
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\frametitle{Questions?}
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@ -236,6 +340,84 @@ Washington State University \\ % Your institution for the title page
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% - Data Sizes
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% - Data Sizes
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%--------------------------------
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%--------------------------------
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%-------------------------------
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\begin{frame}
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\frametitle{Data Sources}
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%TODO: add citations
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Data sources
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\begin{itemize}
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\item ClinicalTrials.gov
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\begin{itemize}
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\item AACT-CTTI
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\item Scraping historical snapshots
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\end{itemize}
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\item ICD-10 (CMS and WHO)
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\item IHME Global Burden of Disease
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\item Structured Product Labels
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\item USP Drug Classification
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\item Drugs@FDA: RxNav / RxNorm / MeSH
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\end{itemize}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Linking data}
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%
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The following linking process was used:
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\begin{enumerate}
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\item AACT trials to snapshots (internal ID)
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\item AACT trials to ICD-10 (hand match)
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\item ICD-10 to IHME (IHME)
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\item Snapshots to drug brands (RxNorm/RxNav/MeSh, SPL)
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\item AACT to USP DC alternates (RxNorm, USP DC, hand match)
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\end{enumerate}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Measures of Causes and Effects}
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\begin{itemize}
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\item Final Status: Measured from AACT - status when trial is over.
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\item Competitors on Market: Measured by the number of drugs
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\begin{itemize}
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\item with same active ingredients (at the time of the snapshot)
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\item sharing the USP DC category and class (in 2023)
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\end{itemize}
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\item Enrollment: Measured by enrollment status at the snapshot level.
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\end{itemize}
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Adjustment set}
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\begin{itemize}
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\item Population Measures
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\begin{itemize}
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\item IHME Global Disease Burden: QUALYs, spread over 5 levels of the Social Development Index
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\end{itemize}
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\item Beliefs about safety \& efficacy: Restricted to Phase 3 trials.
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\item Disease Type: Hierarchal parameters in model
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\end{itemize}
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Note the implicit conditioning on trials treating diseases with IHME data\footnote{
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IHME does not track data for W61.62XD: Struck by duck, subsequent encounter
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}.
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\end{frame}
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%-------------------------------
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\begin{frame}
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\frametitle{Other Details}
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Other Trial Selection Criteria
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\begin{itemize}
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\item Interventional Study
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\item Involved an FDA Regulated Drug
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\item Phase 3 trial
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\item Started after 2010-01-01
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\item Ended before 2022-01-01
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\end{itemize}
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\end{frame}
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%-------------------------------
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%-------------------------------
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\begin{frame}
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\begin{frame}
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\frametitle{Questions?}
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\frametitle{Questions?}
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