recording current work

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 \/\/\/\/\/
 

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".
+In 1938 President Franklin D Rosevelt signed the Food, Drug, and Cosmetic Act,
-As of Sept 2022 \todo{Check Date} they have approved 6,602 currently-marketed compounds with Structured Product Labels (SPL) 
+granting the Food and Drug Administration (FDA) authority to require 
-and 10,983 previously-marketed SPLs. 
+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}.
+In 1999, they began requiring that drug developers register and 
-This provides a public mechanism where clinical trial sponsors are responsible to explain
+publish clinical trials on \url{https://clinicaltrials.gov}.
-what they are trying to acheive and how it will be measured, as well as provide the public the ability to
+This provides a public mechanism where clinical trial sponsors are 
-search and find trials that they might enroll in.
+responsible to explain what they are trying to acheive and how it will be 
-Data such as this has become part of multiple datasets 
+measured, as well as provide the public the ability to search and find trials 
-(e.g. the Cortellis Investigational Drugs dataset or the AACT dataset from the Clinical Trials Transformation Intiative) 
+that they might enroll in.
-used to evaluate what drugs might be entering the market soon.
+Multiple derived datasets such as the Cortellis Investigational Drugs dataset 
-This brings up a question: can we use this public data on clinical trials to describe what effects their success or failure?
+or the AACT dataset from the Clinical Trials Transformation Intiative
-In this work, I use updates to records on \url{https://ClinicalTrials.gov} to disentangle 
+integrate these data. 
-the effect of participant enrollment and drugs on the market affect the success or failure of clinical trials.
+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.