saving current work and plans

claude_rewrite
will king 1 year ago
parent 1f396d856c
commit aaaf153168

@ -0,0 +1,41 @@
How do I begin work on stuff
- next step is causal story. key points include
- we are trying to separate strategic and operational concerns. (why is this a difficult problem?)
- we can't trust what we are told
- terminations could be due to safety, strategic, or operational concerns.
- explaining confounding between
-population/market and market conditions.
- market conditions and enrollment.
- population/market and enrollment.
- describe other confounders
- safety and effectiveness
- duration <--> enrollment/termination
- Condition
- Decision to procede with Phase III trial
- How do I handle this?
- Introduce Do-Calculus
- DAG model
- What do I need to control for, in some form or other?
- Introduce Data
- Clinical Trial Progression
- AACT gives us information on
- terminated/completed status
- compound-indication pairs
- MeSH/RxNorm links
- Snapshots
- Market Conditions
- can't directly measure alternate treatments/standards of care.
- Can get measures of USP - formulary alternatives
- Can get number of generics or brand names with same drug.
- Population Sizes
- IHME Global Burden of Disease dataset. Best measure of impact of a given disease category.
- DALY's
- How much data do I have?
- Econometric model
- for a given state, what is the probability it will terminate?
- more accurately for my dist-diff analysis: for a given state, what is the distribution of the probabilities it will terminate?
- basic bernoulli-logistic model, linear in parameters.
- What are the specific things I am looking at?
- number of competing treatments.
- delaying close of enrollment.

@ -2,31 +2,33 @@
\graphicspath{{\subfix{Assets/img/}}} \graphicspath{{\subfix{Assets/img/}}}
\begin{document} \begin{document}
% Introduce clinicaltrials.gov % % Introduce clinicaltrials.gov
% - Describe different statuses % % - Describe different statuses
% - status flowchart % % - status flowchart
% Introduce causal model % % Introduce causal model
% - Diagram % % - Diagram
% - List each node and what they influence (and why) % % - List each node and what they influence (and why)
% Begin Discussing Data % % Begin Discussing Data
% - Where did I get data for each node? % % - Where did I get data for each node?
%
When any clinical trial is conducted, it goes through three distinct stages: % When any clinical trial is conducted, it goes through three distinct stages:
pre-trial, active, and decision to conclude. % pre-trial, active, and decision to conclude.
In figure \ref{Fig:Stages}, you can see the component parts of each stage. % 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
\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 Because running randomized experiments on companies running clinical trials
is unlikely to to happen anytime soon, is unlikely to to happen anytime soon,

@ -3,6 +3,10 @@
\begin{document} \begin{document}
Begin by talking about goal, what does it mean? This might need some work prior to give more background.
%%%%% \/\/\/\/\/ OLD STUFF \/\/\/\/\/
Because running experiments on companies running clinical trials is not going Because running experiments on companies running clinical trials is not going
to happen anytime soon, causal identification will depend on creating a to happen anytime soon, causal identification will depend on creating a
structural causal model. structural causal model.

@ -14,7 +14,8 @@
% - % -
% - % -
To understand how my administrative clinical trial is obtained, To understand how my administrative clinical trial data is obtained
and what it can be used for,
let's take a look at how trial investigators record data on let's take a look at how trial investigators record data on
\url{ClinicalTrials.gov} operate. \url{ClinicalTrials.gov} operate.
Figure \ref{Fig:Stages} illuistrates the process I describe below. Figure \ref{Fig:Stages} illuistrates the process I describe below.
@ -39,7 +40,7 @@ marked as ``Terminated'' on
\url{ClinicalTrials.gov}. \url{ClinicalTrials.gov}.
\begin{figure}[H] %use [H] to fix the figure here. \begin{figure}%[H] %use [H] to fix the figure here.
\includegraphics[width=\textwidth]{../assets/img/ClinicalTrialStagesAndStatuses} \includegraphics[width=\textwidth]{../assets/img/ClinicalTrialStagesAndStatuses}
\par \small \par \small
Diamonds represent decision points while Diamonds represent decision points while
@ -62,55 +63,31 @@ Unfortunately, although termination documentation typically includes a
description of a reason for the clinical trial termination, this doesn't necessarily description of a reason for the clinical trial termination, this doesn't necessarily
list all the reasons contributing to the trial termination and may not exist for a given trial. list all the reasons contributing to the trial termination and may not exist for a given trial.
% SHOULD I EXPLAIN THE CLINICAL TRIALS DATA, i.e. AACT and SCRAPING EFFORT YET? As a trial goes through the different stages of recruitment, the investigators
% For this reason we use administrative data, the records of clinical trial states, to track how trials proceed. update the records on ClinicalTrials.gov.
% There is also the issue of confounding between different Even though there are only a few times that investigators are required
to update this information, it tends to be updated somewhat regularly as it is
a way to communicate with potential enrollees.
When a trial is first posted, it tends to include information
such as planned enrollment,
planned end dates,
the sites at which it is being conducted,
the diseases that it is investigating,
the drugs or other treatments that will be used,
the experimental arms that will be used,
and who is sponsoring the trial.
As enrollment is opened and closed and sites are added or removed,
investigators will update the status and information
to help doctors and potential participants understand whether they should apply.
% \begin{enumerate} % -
% \item The compound demonstrates sufficient safety and efficacy, and proceeds in the appoval process. % -
% \label{Item:EndSuccess} % -
% \item The compound fails to demonstrate sufficient safety and efficacy, and the approval process halts. % -
% \label{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{Potential States of Knowledge from a clinical trial}\label{tab:StatesOfKnowledge}
% \begin{center}
% \begin{tabular}{p{0.15\textwidth} p{0.2\textwidth}||p{0.25\textwidth}|p{0.25\textwidth}|}
% \cline{3-4}
% \multicolumn{2}{c|}{Drug-Indication Match} & safe and efficacious & not safe or not efficatious \\
% \hline
% \hline
% \multirow{2}{0.15\textwidth}{Operations} & Success & Known good & Known bad \\
% \cline{2-4}
% & Failure & \multicolumn{2}{c|}{Unkown} \\
% \cline{2-4}
% \end{tabular}
% \end{center}
% \end{table}
%
%
% \begin{table}
% \caption{Clinical Trial end states}\label{tab:ClinicalTrialEndStates}
% \begin{center}
% \begin{tabular}{p{0.15\textwidth} p{0.2\textwidth}||p{0.25\textwidth}|p{0.25\textwidth}|}
% \cline{3-4}
% \multicolumn{2}{c|}{Drug-Indication Match} & safe and efficacious & not safe or not efficatious \\
% \hline
% \hline
% \multirow{2}{0.15\textwidth}{Operations} & Success & Completion & Completion or Termination \\
% \cline{2-4}
% & Failure & \multicolumn{2}{c|}{Termination} \\
% \cline{2-4}
% \end{tabular}
% \end{center}
% \end{table}
\end{document} \end{document}

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