From e5e052db3501936422c760ec8f88d993a7e20ccb Mon Sep 17 00:00:00 2001 From: Will King Date: Fri, 30 Aug 2024 09:34:18 -0700 Subject: [PATCH] updated introduction --- Latex/Paper/Main.tex | 3 ++ Latex/Paper/sections/01_introduction.tex | 39 +++++++++++++++++++----- 2 files changed, 35 insertions(+), 7 deletions(-) diff --git a/Latex/Paper/Main.tex b/Latex/Paper/Main.tex index e2da6b2..8a667ca 100644 --- a/Latex/Paper/Main.tex +++ b/Latex/Paper/Main.tex @@ -26,6 +26,9 @@ \title{The effects of market conditions on enrollment and completion of clinical trials\\ \small{Preliminary Draft}} \author{William King} +\usepackage{multirow} +\usepackage{multicol} + \begin{document} \maketitle diff --git a/Latex/Paper/sections/01_introduction.tex b/Latex/Paper/sections/01_introduction.tex index 40f2b2a..b01c214 100644 --- a/Latex/Paper/sections/01_introduction.tex +++ b/Latex/Paper/sections/01_introduction.tex @@ -12,15 +12,35 @@ and fiscal policy question that has been debated for decades. Due to the complicated legal and competitive landscape, unintended consequences are common -\cite{van_der_gronde_addressing_2017}. -One critical aspect to successfully introduce a novel pharmaceutical or even -a generic compound is to establish that the drug as packaged and sold will +\cite{vandergronde_addressingchallengehighpriced_2017}. +One essential step to introduce a novel pharmaceutical - or even +to begin selling a generic compound - is to establish that the drug as packaged and sold will have acceptable safety and efficacy profiles. -This is done using clinical trials. +When evaluating these compounds in a clinical trial, both outcomes are possible: +\begin{enumerate} + \item The compound demonstrates sufficient safety and efficacy, and proceeds in the appoval process. \ref{Item:EndSuccess} + \item The compound fails to demonstrate sufficient safety and efficacy, and the approval process halts. \ref{Item:EndFail} + \item The trial is terminated before it can acheive one of the first two outcomes, for reasons unrelated to safety and efficacy concerns. \label{Item:Terminate} +\end{enumerate} + +\begin{table} + \caption{}\label{tab:} + \begin{center} + \begin{tabular}{p{0.4\textwidth}|p{0.3\textwidth}|p{0.3\textwidth}|} + \cline{2-3} + \multirow{2}{*}{} & \multicolumn{2}{c|}{Drug-Indication Match} \\ + \cline{2-3} + & safe and efficacious & not safe nor efficatious \\ + \hline + \multirow{2}{*}{Discovery process} & Known good & Known bad \\ + \cline{2-3} + & Unknown & Unkown \\ + \cline{2-3} + \end{tabular} + \end{center} +\end{table} + -To adequately guide public policy it is crucial that robust, causally-identified -statistical models are available to describe the interaction between -various players within the space. While it is known that pharmaceutical companies withdraw some drugs from their development pipeline due to commercialization concerns ( @@ -34,6 +54,11 @@ the market, patients might be loath to enroll in clinical trials, causing the trial to fail for reasons unrelated to the scientific or commercial viability of the therapy. + +To adequately guide public policy it is crucial that robust, causally-identified +statistical models are available to describe the interaction between +various players within the space. + This work endeavors to estimate the change in probability of successful completion of a clinical trial due to the existence of alternative drugs on the market. In particular, it seeks to establish whether such an impact is mediated