From 7873b5f1acbb44ba76668f50c9de4a7293c8fa4f Mon Sep 17 00:00:00 2001 From: will king Date: Fri, 15 Nov 2024 10:36:50 -0800 Subject: [PATCH] recording current work --- Latex/Paper/sections/10_CausalStory.tex | 23 +++++++++++++- Latex/Paper/sections/11_intro_and_lit.tex | 38 +++++++++++++++-------- 2 files changed, 47 insertions(+), 14 deletions(-) diff --git a/Latex/Paper/sections/10_CausalStory.tex b/Latex/Paper/sections/10_CausalStory.tex index 874a5f5..bded858 100644 --- a/Latex/Paper/sections/10_CausalStory.tex +++ b/Latex/Paper/sections/10_CausalStory.tex @@ -3,7 +3,28 @@ \begin{document} -Begin by talking about goal, what does it mean? This might need some work prior to give more background. +% Begin by talking about goal, what does it mean? This might need some work prior to give more background. +As I am trying to separate strategic concerns +(the effect of a marginal treatment methodology) +and an operational concern +(the effect of a delay in closing enrollment), +we need to look at what confounds these effects and how we might measure them. + +There are a few fundamental issues. +The first is that the severity of the disease and the size of the population +who has that disease affects the ease of enrolling participants. +For example, a large population may make it easier to find enough participants +to achieve the required statistical discrimination between +control and treatment. +Second, for some diseases there exists an endogenous dynamic +between the treatments available for a disease and the +market size/population with that disease. +\authorcite{cerda_EndogenousInnovations_2007} proposes two mechanisms +that link drugs on the market and market size. +The first is that a large market will tends to have more drugs to treat it. +The inverse is that for many chronic diseases with high mortality rates, +more drugs cause better survivability, increasing the size of those markets. + %%%%% \/\/\/\/\/ OLD STUFF \/\/\/\/\/ diff --git a/Latex/Paper/sections/11_intro_and_lit.tex b/Latex/Paper/sections/11_intro_and_lit.tex index 57121d6..8df340f 100644 --- a/Latex/Paper/sections/11_intro_and_lit.tex +++ b/Latex/Paper/sections/11_intro_and_lit.tex @@ -3,20 +3,32 @@ \begin{document} -In 19xx the United States Food and Drug Administration (FDA) was created to "QUOTE". -As of Sept 2022 \todo{Check Date} they have approved 6,602 currently-marketed compounds with Structured Product Labels (SPL) -and 10,983 previously-marketed SPLs. +In 1938 President Franklin D Rosevelt signed the Food, Drug, and Cosmetic Act, +granting the Food and Drug Administration (FDA) authority to require +pre-market approval of pharmaceuticals. +\cite{commissioner_MilestonesUS_2023}. +As of Sept 2022 \todo{Check Date} they have approved 6,602 currently-marketed +compounds with Structured Product Labels (SPLs) +and 10,983 previously-marketed SPLs +\cite{commissioner_NSDE_2024}. %from nsde table. Get number of unique application_nubmers_or_citations with most recent end date as null. -In 2007, they began requiring that drug developers register and publish clinical trials on \url{https://clinicaltrials.gov}. -This provides a public mechanism where clinical trial sponsors are responsible to explain -what they are trying to acheive and how it will be measured, as well as provide the public the ability to -search and find trials that they might enroll in. -Data such as this has become part of multiple datasets -(e.g. the Cortellis Investigational Drugs dataset or the AACT dataset from the Clinical Trials Transformation Intiative) -used to evaluate what drugs might be entering the market soon. -This brings up a question: can we use this public data on clinical trials to describe what effects their success or failure? -In this work, I use updates to records on \url{https://ClinicalTrials.gov} to disentangle -the effect of participant enrollment and drugs on the market affect the success or failure of clinical trials. +In 1999, they began requiring that drug developers register and +publish clinical trials on \url{https://clinicaltrials.gov}. +This provides a public mechanism where clinical trial sponsors are +responsible to explain what they are trying to acheive and how it will be +measured, as well as provide the public the ability to search and find trials +that they might enroll in. +Multiple derived datasets such as the Cortellis Investigational Drugs dataset +or the AACT dataset from the Clinical Trials Transformation Intiative +integrate these data. +This brings up a question: +Can we use this public data on clinical trials to identify what effects the +success or failure of trials? +In this work, I use updates to records on +\url{https://ClinicalTrials.gov} +to do exactly that, disentangle the effect of participant enrollment +and competing drugs on the market affect the success or failure of +clinical trials. %Describe how clinical trials fit into the drug development landscape and how they proceed Clinical trials are a required part of drug development.