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117 lines
5.0 KiB
TeX
117 lines
5.0 KiB
TeX
\documentclass[../Main.tex]{subfiles}
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\graphicspath{{\subfix{Assets/img/}}}
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\begin{document}
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% Clinical Trials Background Outline
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% - ClinicalTrials.gov
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% - Clincial trial progression
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% -
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% -
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% -
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% -
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% -
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% -
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% -
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To understand how my administrative clinical trial is obtained,
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let's take a look at how trial investigators record data on
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\url{ClinicalTrials.gov} operate.
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Figure \ref{Fig:Stages} illuistrates the process I describe below.
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During the Pre-Trial period the trial investigators will design the trial,
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choose primary and secondary objectives,
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and decide on how many participants they need to enroll.
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Once they have decided on these details, they post the trial to \url{ClinicalTrials.com}
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and decide on a date to begin enrolling trial participants.
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If the investigators decide to not continue with the trial before enrolling any participants,
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the trial is marked as ``Withdrawn''.
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On the other hand, if they begin enrolling participants, there are two methods to do so.
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The first is to enter a general ``Recruiting'' state, where patients attempt to enroll.
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The second is to enter an "Enrollment by invitation only" state.
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After a trial has enrolled their participants, they wil typically move to an
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"Active, not recruiting" state to inform potential participants that they are
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not recruiting.
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Finally, when the investigators have obtained enough data to achieve their primary
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objective, the clinical trial will be closed, and marked as ``Completed'' in
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\url{ClinicalTrials.gov}
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If the trial is closed before achieving the primary objective, the trial is
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marked as ``Terminated'' on
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\url{ClinicalTrials.gov}.
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\begin{figure}[H] %use [H] to fix the figure here.
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\includegraphics[width=\textwidth]{../assets/img/ClinicalTrialStagesAndStatuses}
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\par \small
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Diamonds represent decision points while
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Squares represent states of the clinical trial and Rhombuses represend data obtained by the trial.
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\caption[Clinical Trial Stages and Progression]{Clinical Trial Stages and Progression}
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\label{Fig:Stages}
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\end{figure}
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Note the information we obtain about the trial from the final status:
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``Withdrawn'', ``Terminated'', or ``Completed''.
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Although \cite{khm} describes a clinical failure due to safety or efficacy as a
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\textit{scientific} failure, it is better described as a compound failure.
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Discovering that a compound doesn't work as hoped is not a failure but the whole
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purpose of the clinical trials process.
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On the other hand, when a trial terminates early due to reasons
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other than safety or efficacy concerns, the trial operator does not learn
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if the drug is effective or safe.
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This is a true failure in that we did not learn if the drug was effective or not.
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Unfortunately, although termination documentation typically includes a
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description of a reason for the clinical trial termination, this doesn't necessarily
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list all the reasons contributing to the trial termination and may not exist for a given trial.
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% SHOULD I EXPLAIN THE CLINICAL TRIALS DATA, i.e. AACT and SCRAPING EFFORT YET?
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% For this reason we use administrative data, the records of clinical trial states, to track how trials proceed.
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% There is also the issue of confounding between different
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% \begin{enumerate}
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% \item The compound demonstrates sufficient safety and efficacy, and proceeds in the appoval process.
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% \label{Item:EndSuccess}
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% \item The compound fails to demonstrate sufficient safety and efficacy, and the approval process halts.
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% \label{Item:EndFail}
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% \item The trial is terminated before it can acheive one of the first two
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% outcomes, for reasons unrelated to safety and efficacy concerns.
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% \label{Item:Terminate}
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% \end{enumerate}
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%
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%
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% \begin{table}
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% \caption{Potential States of Knowledge from a clinical trial}\label{tab:StatesOfKnowledge}
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% \begin{center}
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% \begin{tabular}{p{0.15\textwidth} p{0.2\textwidth}||p{0.25\textwidth}|p{0.25\textwidth}|}
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% \cline{3-4}
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% \multicolumn{2}{c|}{Drug-Indication Match} & safe and efficacious & not safe or not efficatious \\
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% \hline
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% \hline
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% \multirow{2}{0.15\textwidth}{Operations} & Success & Known good & Known bad \\
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% \cline{2-4}
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% & Failure & \multicolumn{2}{c|}{Unkown} \\
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% \cline{2-4}
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% \end{tabular}
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% \end{center}
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% \end{table}
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%
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%
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% \begin{table}
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% \caption{Clinical Trial end states}\label{tab:ClinicalTrialEndStates}
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% \begin{center}
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% \begin{tabular}{p{0.15\textwidth} p{0.2\textwidth}||p{0.25\textwidth}|p{0.25\textwidth}|}
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% \cline{3-4}
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% \multicolumn{2}{c|}{Drug-Indication Match} & safe and efficacious & not safe or not efficatious \\
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% \hline
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% \hline
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% \multirow{2}{0.15\textwidth}{Operations} & Success & Completion & Completion or Termination \\
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% \cline{2-4}
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% & Failure & \multicolumn{2}{c|}{Termination} \\
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% \cline{2-4}
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% \end{tabular}
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% \end{center}
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% \end{table}
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\end{document}
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