Update 'Concept Paper 2021 09 03'

Concept-Paper-2021-09-03.md

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 Project Concept Proposal
 Motivation
 Pharmaceutical R&D lies at the crux of various shaping influences. First, the R&D is difficult to complete with many failures for each success. Second, the regulatory agency imposes minimum requirements in both safety and efficacy that must be met, while passing through a path of tests (of which there are multiple paths available). Third, each approved drug must compete in an imperfect market to meet certain therapeutic needs. Although a given drug may have a period of exclusivity related to its chemical formulation, it may be that it always faces competition from chemically dissimilar compounds. Fifth, entry of competing products is not guaranteed. Finally, the way that pharmaceutical compounds are paid for – involving a mixture of private, insurance, and government funds – makes tracking profit incentives quite difficult.
+
 Because the Federal Government pays for a significant share of prescriptions for those over the age of 65 through the medicare program, identifying the effects of proposed laws on expenditures is a concern of the Congressional Budget Office. Examples of general concerns include:
 
-    • How will changes in reimbursment rates affect
-        ◦ R&D in competing drugs?
-        ◦ Development of innovator drugs?
-    • How will changes in testing/trial requirements affect entry of new and generic drugs?
+- How will changes in reimbursment rates affect
+- R&D in competing drugs?
+- Development of innovator drugs?
+- How will changes in testing/trial requirements affect entry of new and generic drugs?
     
 Answers to these questions feed back into the fundamental question CBO faces: how will this affect the federal budget down the road.
-Background on work this summer
+
+## Background on work this summer
 I spent the summer working with CBO’s Health Analysis Division on developing a dataset that, under ideal circumstances, describes how registered aspects of clinical trials change over time. These include:
 
-    • How sponsoring organizations change.
-    • Expected vs Actual 
-        ◦ time to completion
-        ◦ enrollment
-    • Roughly when trials transition between recruiting statuses, e.g. percentage of time spent recruiting.
-        ◦ Possibly measurable at different sites.
+- How sponsoring organizations change.
+- Expected vs Actual 
+- time to completion
+- enrollment
+- Roughly when trials transition between recruiting statuses, e.g. percentage of time spent recruiting.
+- Possibly measurable at different sites.
         
 The aformentioned ideal circumstances occur when:
-    • The trial was started after <<some point (2010ish)>>, so version information is captured from the beginning of the trial.
-    • The trial has concluded.
-Objectives
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+- The trial was started after <<some point (2010ish)>>, so version information is captured from the beginning of the trial.
+- The trial has concluded.
+
+# Objectives
 The objective of this research project is to estimate 
-Potential Topics
+
+## Potential Topics
 Some areas of interest.
+
     1. Estimate Probability of Success of moving between Phases. 
             1. Depends on either FDA data or use of an ML matching process (Hard to do right).
         2. Follow E.K.’s approach of splitting Technical vs Scientific failures to progress.