From 5a77259f3e9c7d4c837379dd2195aad10c906478 Mon Sep 17 00:00:00 2001 From: Will King Date: Fri, 1 Nov 2024 15:10:42 -0700 Subject: [PATCH] new outline to begin writing introdution and lit review --- Latex/Paper/outline2.txt | 43 ++++++++++++++++++++++++++++++++++++++++ 1 file changed, 43 insertions(+) create mode 100644 Latex/Paper/outline2.txt diff --git a/Latex/Paper/outline2.txt b/Latex/Paper/outline2.txt new file mode 100644 index 0000000..9f9f6e7 --- /dev/null +++ b/Latex/Paper/outline2.txt @@ -0,0 +1,43 @@ +In 19xx the United States Food and Drug administration was created to "QUOTE". +Since XXXX they have . +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. +%this has become part of multiple datasets (cortellis) 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 separate the effect of + +%Describe how clinical trials fit into the drug development landscape and how they proceed +Clinical trials are a required part of drug development. +Not only does the FDA require that a series of clinical trials demonstrate sufficient safety and efficacy of +a novel pharmaceutical compound or device, producers of derivative medicines may be required to ensure that +their generic small molecule compound -- such as ibuprofen or levothyroxine -- matches the +performance of the originiator drug if delivery or dosage is changed. +For large molecule generics (termed biosimilars) such as Adalimumab +(Brand name Humira, with biosimilars Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, +Hyrimoz, Idacio, Simlandi, Yuflyma, and Yusimry), +the biosimilars are required to prove they have similar efficacy and safety to the +reference drug. + +When registering these clinical trials +% discuss how these are registered and what data is published. +% Include image and discuss stages +% Discuss challenges faced + +% Introduce my work + +At least in the world of drug development, these trials take place in a wider framework of Phases +% Now talk about phases, begin introducing work by Chris Adams +% Lead into lit review + + +% Causality + +% Data + +% Economic Model + +% Results + +% Conclusion