You cannot select more than 25 topics
Topics must start with a letter or number, can include dashes ('-') and can be up to 35 characters long.
80 lines
3.0 KiB
TeX
80 lines
3.0 KiB
TeX
\documentclass[../Main.tex]{subfiles}
|
|
\graphicspath{{\subfix{Assets/img/}}}
|
|
|
|
\begin{document}
|
|
% % Introduce clinicaltrials.gov
|
|
% % - Describe different statuses
|
|
% % - status flowchart
|
|
% % Introduce causal model
|
|
% % - Diagram
|
|
% % - List each node and what they influence (and why)
|
|
% % Begin Discussing Data
|
|
% % - Where did I get data for each node?
|
|
%
|
|
% When any clinical trial is conducted, it goes through three distinct stages:
|
|
% pre-trial, active, and decision to conclude.
|
|
% In figure \ref{Fig:Stages}, you can see the component parts of each stage.
|
|
%
|
|
% \begin{figure}[H] %use [H] to fix the figure here.
|
|
% \includegraphics[width=\textwidth]{../assets/img/ClinicalTrialStagesAndStatuses}
|
|
% \caption{Model of Statuses}
|
|
% \label{Fig:Stages}
|
|
% \end{figure}
|
|
%
|
|
% In the pre-trial stage, the sponsoring organization chooses to run the trial,
|
|
% they register the trial on \url{ClinicalTrials.gov}, and then decide if they
|
|
% will begin enrollment.
|
|
% Many registered trials are withdrawn at this point, before the trial has opened
|
|
% for enrollment.
|
|
% Once enrollment has opened
|
|
|
|
|
|
|
|
Because running randomized experiments on companies running clinical trials
|
|
is unlikely to to happen anytime soon,
|
|
causal identification will depend on observational methods.
|
|
I use the do-calculus approach developed by Judea Pearl
|
|
\cite{pearl_CausalityModels_2009}
|
|
to describe what affects the success of a Phase III clinical trial.
|
|
I then use that model to derive the econometric model capable of estimating
|
|
the effect of extending the recruiting period or of having an additional
|
|
competing drug.
|
|
|
|
|
|
|
|
% In \cref{Fig:CausalModel} I diagram the directed acyclic graph that describes
|
|
% the data generating model.
|
|
The proposed data generating model consists of a decision maker
|
|
-- the study sponsor --
|
|
who must decide whether to let a trial run to completion or terminate
|
|
the trial early.
|
|
While receiving updates regarding the status of the trial, they try to
|
|
answer questions such as:
|
|
\begin{itemize}
|
|
\item Do I need to terminate the trial due to safety incidents?
|
|
\item Does it appear that the drug is effective?
|
|
\item Are we recruiting enough participants to achive the statistical
|
|
results we need?
|
|
\item Does the current market conditions and expectations about
|
|
returns on
|
|
investment justify the expenditures we are making?
|
|
\end{itemize}
|
|
Althought I treat this as a single agent, in reality, there are multiple
|
|
stakeholders involved in chosing whether the trial should continue, including
|
|
those running the trial (which may be a separate firm),
|
|
the company developing the drug, additional rightsholders,
|
|
or funding organizations.
|
|
|
|
% When appropriate, the study sponsor terminates the trial.
|
|
% If there are not enough issues to terminate the trial, it continues until it
|
|
% is completed.
|
|
|
|
In the United States, clinical trials are required by law to be registered on
|
|
\url{ClinicalTrials.gov}, where they are made available to the public.
|
|
Trials must be registered
|
|
|
|
%
|
|
|
|
|
|
\end{document}
|