Adjusted title, planned reorder of data/causal section.

claude_rewrite
will king 2 years ago
parent f8c9646f02
commit 56e18b8cb8

@ -24,7 +24,8 @@
\titlespacing*{\paragraph} \titlespacing*{\paragraph}
{0pt}{3.25ex plus 1ex minus .2ex}{1.5ex plus .2ex} {0pt}{3.25ex plus 1ex minus .2ex}{1.5ex plus .2ex}
\title{The effects of market conditions on enrollment and completion of clinical trials\\ \small{Preliminary Draft}} \title{The effects of market conditions and enrollment on the
completion of clinical trials\\ \small{Preliminary Draft}}
\author{William King} \author{William King}
\usepackage{multirow} \usepackage{multirow}

@ -2,29 +2,60 @@
\graphicspath{{\subfix{Assets/img/}}} \graphicspath{{\subfix{Assets/img/}}}
\begin{document} \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?
Because running experiments on companies running clinical trials is not going Because running randomized experiments on companies running clinical trials
to happen anytime soon, causal identification will depend on creating a is unlikely to to happen anytime soon,
structural causal model. causal identification will depend on observational methods.
In \cref{Fig:CausalModel} I diagram the directed acyclic graph that describes I use the do-calculus approach developed by Judea Pearl
the data generating model. \cite{pearl_CausalityModels_2009}
The proposed data generating model consists of a decision maker, the study to describe what affects the success of a Phase III clinical trial.
sponsor, who must decide whether to let a trial run to completion or terminate 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. the trial early.
While receiving updates regarding the status of the trial, they ask questions While receiving updates regarding the status of the trial, they try to
such as: answer questions such as:
\begin{itemize} \begin{itemize}
\item Do I need to terminate the trial due to safety incidents? \item Do I need to terminate the trial due to safety incidents?
\item Does it appear that the drug is effective enough to achieve our \item Does it appear that the drug is effective?
goals, justifying continuing the trial?
\item Are we recruiting enough participants to achive the statistical \item Are we recruiting enough participants to achive the statistical
results we need? results we need?
\item Does the current market conditions and expectations about returns on \item Does the current market conditions and expectations about
returns on
investment justify the expenditures we are making? investment justify the expenditures we are making?
\end{itemize} \end{itemize}
When appropriate, the study sponsor terminates the trial. Althought I treat this as a single agent, in reality, there are multiple
If there are not enough issues to terminate the trial, it continues until it stakeholders involved in chosing whether the trial should continue, including
is completed. 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
%
While conducting a trial, the safety and efficacy of a drug are driven by While conducting a trial, the safety and efficacy of a drug are driven by
fundamental pharmacokinetic properties of the compounds. fundamental pharmacokinetic properties of the compounds.
@ -36,19 +67,25 @@ Of course, these decisions are both affected by the specific condition being
treated due to differences in the severity of the symptoms. treated due to differences in the severity of the symptoms.
When a trial has been started, it comes time to recruit participancts. When a trial has been started, it comes time to recruit participancts.
Participants frequently depend on the advice of their physician when deciding The enrollment of participants in a trial depends on a few factors.
Participants usually depend on the advice of their physician when deciding
to join a trial or not. to join a trial or not.
As these physicians have a duty to seek their patients best interest; they, along As these physicians have a duty to seek their patients best interest; they, along
with their patients will evaluate if the previously observed safety and efficacy with their patients will evaluate if the previously observed safety and efficacy
results justify joining the trial over using current standard treatments. results justify joining the trial in contrast to using the current standard
Thus the current market conditions may affect the rate at which participants of care.
enroll in the trial. Thus enrollment rates are influenced by the treatments currently on the market.
Recruitment can also be hindered if disease has a low impact
-- in which participants might have little incentive to join --
or if there are few people who have the disease.
The overall impact of the disease also influences whether or not there are
already drugs on the market to treat that disease.
The enrollment of participants in a trial depends on a few other factors.
The condition or disease of interest and how it progresses will determine how long The condition or disease of interest and how it progresses will determine how long
recruitiment will be held open versus just an observation of treatment arms. recruitiment will be held open versus just an observation of treatment arms.
Aditionally, a trial that has already reached a high enough enrollment will often Aditionally, a trial that has already reached a high enough enrollment will often
close recruitment by switching to an "Active, not recruiting" stage to manage costs. close recruitment.
Both of these are reported as "Active, not recruting" to ClinicalTrials.gov.
Finally, enrolling participants depends on how difficult it is to find people Finally, enrolling participants depends on how difficult it is to find people
who suffer from the condition of interest. who suffer from the condition of interest.

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