From 94f16777fc361a8757239c58d640251161c2f673 Mon Sep 17 00:00:00 2001 From: Will King Date: Wed, 4 Oct 2023 11:39:44 -0700 Subject: [PATCH] added initial background information on clinical trials --- ClinicalTrialsEstimation | 2 +- Latex/Presentation/.presentation.tex.swp | Bin 0 -> 32768 bytes Latex/Presentation/presentation.dvi | Bin 0 -> 162976 bytes Latex/Presentation/presentation.tex | 284 ++++++++++++++++++++--- Latex/assets/preambles/BibPreamble.tex | 2 +- 5 files changed, 255 insertions(+), 33 deletions(-) create mode 100644 Latex/Presentation/.presentation.tex.swp create mode 100644 Latex/Presentation/presentation.dvi diff --git a/ClinicalTrialsEstimation b/ClinicalTrialsEstimation index 09d0faa..a7e1f71 160000 --- a/ClinicalTrialsEstimation +++ b/ClinicalTrialsEstimation @@ -1 +1 @@ -Subproject commit 09d0faa84c30f0735b0a16a3159afd2d816e9296 +Subproject commit a7e1f71e124bc8f27621373ba6b66234f091834f diff --git a/Latex/Presentation/.presentation.tex.swp 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+\end{frame} +%------------------------------- \begin{frame}[allowframebreaks] %Allow frame breaks \frametitle{Overview} % Table of contents slide, comment this out to remove it \tableofcontents \end{frame} +%------------------------------- %------------------------------------------------------------------------------------- -%%%%%%%%%%%%%%%%%%%% Developing the Model%%%%%%%%%%%%%%%%%%%%%%%% -\section{Money: Supply and Demand} +%%%%%%%%%%%%%%%%%%%% Introduction and Background %%%%%%%%%%%%%%%%%%%%%%%% +\section{Background} +% TOC +% - Background on drug process +% - Literature on clinical trials +% - My questions %------------------------------------------------------------------------------------- + %------------------------------- \begin{frame} - \frametitle{What is Money?} - \begin{block}{Money} - A commodity that is: - \begin{itemize} - \item Medium of exchange: A generally accepted means of payment. - \item Store of value: A method to transfer value from now into the future. - \end{itemize} - \end{block} + \frametitle{Clinical Trials and Drug develoment} + % add info about trials + % - Requirements (pre registered design [2007], updated "regularly" on clinicaltrials.gov) + % - Phases (1,2,3,4, mixed) + % - Safety and Ethicas (oversight boards, restrictions on payments) + % - Approval processes (biologics vs small-molecule) + % add info about drugs - What types of money exist? - \begin{itemize} - \item M0: Currency - \item \textbf{M1: M0 + Checking/bank deposits} - \end{itemize} + The FDA requires clinical trials before approving new drug compounds + \begin{itemize} + \item Pre-registered design + \item Updated regularly on clinicaltrials.gov + \item Often requires an oversight board. + \item Goal is to prove efficacy and safety of a compound/dosage/route. + \item A new drug candidate (NDC) must complete 3 phases of clinical trials before approval. + \item Phases are reviewed with FDA. + \item Not all clinical trials are for new drugs. + \end{itemize} \end{frame} -%------------------------------- +%----------------------------- \begin{frame} - \frametitle{Money Demand} - - Nominal Money Demand - \begin{align} - M^d = P \cdot L(R,Y) - \end{align} - + \frametitle{Literature} \begin{itemize} - \item $Y \uparrow \Rightarrow L(R,Y) \uparrow$ - \item $R \downarrow \Rightarrow L(R,Y) \uparrow$ + \item Ekaterina + \item Adams + \item \end{itemize} +\end{frame} +%----------------------------- +\begin{frame} + \frametitle{Questions of Interest} + + \begin{itemize} + \item How do the competitors on the market affect clinical trial completion? + \item How is this effect moderated by the enrollment of participants? + \end{itemize} +\end{frame} +%------------------------------- +\begin{frame} + \frametitle{Audience Questions} + + \center{What can I clarify?} +\end{frame} +%------------------------------- +%------------------------------------------------------------------------------------- +%%%%%%%%%%%%%%%%%%%% Causality and Data %%%%%%%%%%%%%%%%%%%%%%%% +\section{Causal Story and Data} +% TOC +% - Causal Story (no subsection) +% - Clinical trials: targets specific drug/condition combination. +% - Enrollment process: patients counsel with providers +% - Trials terminate if unsafe, ineffective, unprofitable, or cannot enroll patients +% - Ethical concerns exist throughout. +% - This is complicated by the fact that the experiment reveals information over time. +% - Formalization +% - Data Sources +%------------------------------------------------------------------------------------- + +%------------------------------- +\begin{frame}[shrink=10] %evil option is helpful here. + \frametitle{How do clinical trials proceed?} + \begin{columns}[T] + \begin{column}{0.5\textwidth} + What does a complete trial look like. + \begin{enumerate} + \item Study sponsor comes up with design + \item Apply for NCT ID from ClinicalTrials.gov + \item Begin enrolling participants + \item Update ClinicalTrials.gov to recruit + \item Close Enrollment + \item Update ClinicalTrials.gov as not recruiting* + \item Reach primary objectives + \item Update ClinicalTrials.gov as complete + \item Reach secondary objectives + \item Update ClinicalTrials.gov with more information + \end{enumerate} + \end{column} + \begin{column}{0.5\textwidth} + What does an incomplete trial look like? + \begin{enumerate} + \item Study sponsor comes up with design + \item Apply for NCT ID from ClinicalTrials.gov + \item Begin enrolling participants + \item Update ClinicalTrials.gov to advertise + \item Run into issues: + \begin{itemize} + \item Safety + \item Efficacy + \item Profitability + \item Feasiblity (enrollment, PI leaves, etc.) + \end{itemize} + \item Close Enrollment* + \item Decide to terminate clinical trial. + \item Update ClinicalTrials.gov as terminated. + \end{enumerate} + \end{column} + \end{columns} +\end{frame} +%------------------------------- +\begin{frame} + \frametitle{ClinicalTrials.gov} + Thus ClinicalTrials.gov becomes an (append only) repository of + the ``current'' status of clincal trials. + + + As it is designed to help faciltate enrollment in clinical trials, + the record includes important information such as + + \begin{itemize} + \item drugs + \item study arms + \item conditions + \item expected and final enrollment figures + \item current status + \end{itemize} + + ClinicalTrials.gov also reports the ``history'' from previous + updates. +\end{frame} + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%------------------------------- +%-------------------------------- +%%%%%%%%%%%%%%%%%%%% Causal Formalization +\subsection{Formalization} +% - Introduce basic triangle +% - discuss total vs direct effects +% - +% - Add confounders and controls +% - Introduce backdoor criterion +%-------------------------------- + + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + \end{frame} +%------------------------------- +%-------------------------------- +%%%%%%%%%%%%%%%%%%%% Data sources +\subsection{Data Sources} +% TOC +% - Main Data Sources +% - ClinicalTrials.gov and AACT +% - IHME Burden of Disease +% - Marketing Data +% - MeSH, RxNorm/RxNav +% - How did I Link Data Sources +% - Data Sizes +%-------------------------------- + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%------------------------------- +%------------------------------------------------------------------------------------- +%%%%%%%%%%%%%%%%%%%% Analysis %%%%%%%%%%%%%%%%%%%%%%%% +\section{Analysis} +% TOC +% - Review questions and datasets to use for each +% - +% - +%------------------------------------------------------------------------------------- + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%-------------------------------- +%%%%%%%%%%%%%%%%%%%% Econometric Model +\subsection{Econometric Model} +% - Present model per effect +% - +% - +%-------------------------------- + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%-------------------------------- +%%%%%%%%%%%%%%%%%%%% Results +\subsection{Results} +%-------------------------------- +%-------------------------------- +\subsubsection{Total Effect} +% - Review Parameter Values +% - hyperparameters +% - Table of MLE +% - Distributions +% - betas +% - Table of MLE +% - Distributions +% - Review Posterior Prediction for interventions +%-------------------------------- +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%------------------------------- +%-------------------------------- +\subsubsection{Direct Effects} +% - Review Parameter Values +% - hyperparameters +% - Table of MLE +% - Distributions +% - betas +% - Table of MLE +% - Distributions +% - Review Posterior Prediction for interventions +%-------------------------------- + +%------------------------------- +\begin{frame} + \frametitle{Questions?} + +\end{frame} +%------------------------------- +%------------------------------------------------------------------------------------- +%%%%%%%%%%%%%%%%%%%% Conclusion %%%%%%%%%%%%%%%%%%%%%%%% +\section{Conclusion} +%------------------------------------------------------------------------------------- + +%------------------------------- +\begin{frame} + \frametitle{Final Questions} + + \center{\huge{Time is yours to ask any remaining questions.}} +\end{frame} +%------------------------------------------------------------------------------------- +%%%%%%%%%%%%%%%%%%%% Appendicies %%%%%%%%%%%%%%%%%%%%%%%% +\section{Appendices} +%------------------------------------------------------------------------------------- + %------------------------------- \begin{frame} \frametitle{Equilibrium in the Money Market} @@ -111,11 +338,6 @@ Washington State University \\ % Your institution for the title page \end{figure} \end{frame} %------------------------------- -\begin{frame} - \frametitle{Questions?} - -\end{frame} -%------------------------------- \end{document} %========================================= %\begin{frame} diff --git a/Latex/assets/preambles/BibPreamble.tex b/Latex/assets/preambles/BibPreamble.tex index 8eec975..7217e89 100644 --- a/Latex/assets/preambles/BibPreamble.tex +++ b/Latex/assets/preambles/BibPreamble.tex @@ -4,7 +4,7 @@ %%% Setup Bibliography -\usepackage[backend=biber,style=apa,autocite=inline]{biblatex} +\usepackage[backend=biber,autocite=inline]{biblatex} \addbibresource{./assets/preambles/References.bib}