added plans to structure the lit review

claude_rewrite
will king 2 years ago
parent 89d9fc0d2e
commit d6d67ad55e

@ -3,6 +3,56 @@
\begin{document} \begin{document}
% TODO:
%Need to distinguish that this isn't about drug development specifically, but
% more around clinical trials progress.
% Thoughts:
% - What types of failures do clinical trials have an why do clinical trials fail?
% - What is cited in termination reasons?
% - Discussion on different types of failures:
% 1. Failure to find safe and effective drug
% 2. Failure to collect enough information to determine 1
% - recruiting
% - New information (other studies, changes in standards of care, etc)
% 3. Failure due to other operational/strategic concern.
% - Issues with PI/Sponsors
% - profitability expectations
% - Financial support
% Trials can fail due to issues in one of four categories
% - Scientific: The compound-indication combo is not sufficiently safe or efficatious
% - Strategic: The result from the trial won't meet the company's strategic needs. Profitability for the most part or entry into a drug category they don't want to invest in.
% - Operational: They can't bring resources to bear to achieve goal, e.g. site planning, PI's, delivering enough financial support, etc.
% - Tactical: The plans to discover if the approach is scientifically valid are insufficient. Study design, enrollment strategies, etc.
% The literature examines many different aspects of these.
% strategic influences: elasticicity of innovation, demand pull, patents, etc
% Strategic vs scientific khmelniskaya, hwang.
% operational: Adam George Interview
% tactical: enrollment prediction.
% - Discuss how most studies are about clinical trials as part of the drug development pipeline.
% - Review what we know about causes for failure.
% - Things that correlate with failures. (adams)
% - Causes for failure (khmelnitskaya & hwang)
% - Then talk about studies on clinical trials themselves.
% - Interview with Adam George
% - Poor studies of enrollment prediction.
% -
% - Then talk about what drives approvals/clinical trial activity for drugs
% - Elasticity of innovation
% - No demand pull for novel drugs, but yes for derivatives
% - Population and Market size interact & drive development (jointly determined)
% - This doesn't apply to single trials though
% -
% - Sumarize
% - Thus when trying to study what affects clinical trials we must separate
% - Market & competition effects
% - Population effects
% - Multiple trial failure modes (safety & efficacy, Operational etc)
% -
% -
This paper sits within an intersection of health and industrial organization economics This paper sits within an intersection of health and industrial organization economics
that is frequently studied. that is frequently studied.
Encouraging a strong supply of novel and generic pharmaceuticals contributes Encouraging a strong supply of novel and generic pharmaceuticals contributes
@ -19,7 +69,7 @@ which pharmaceutical companies operate.
% - What causes high costs of drugs? % - What causes high costs of drugs?
% - High level synthesis of discussion regarding causes % - High level synthesis of discussion regarding causes
% - Academic and non-academic sources % - Academic and non-academic sources
% Not particularly applicable
%%%%%%%%%%%%%%%% What do we know about clinical trials? %%%%%%%%%%%%%%%% What do we know about clinical trials?
@ -63,7 +113,7 @@ higher if those strategic terminatations were elimintated
% Waring, Arrosmith, Leach, et al (2015) % Waring, Arrosmith, Leach, et al (2015)
% - Atrition of drug candidates from four major pharma companies % - Atrition of drug candidates from four major pharma companies
% - Looked at how phisicochemical properties affected clinical failure due to safety issues % - Looked at how phisicochemical properties affected clinical failure due to safety issues
%not in this version % not Applicable in this version
@ -73,6 +123,7 @@ higher if those strategic terminatations were elimintated
% Dranov, Garthwaite, and Hermosilla (2022) % Dranov, Garthwaite, and Hermosilla (2022)
% - does the demand-pull theory of R&D explain novel compound development? % - does the demand-pull theory of R&D explain novel compound development?
% - no, it is biased towards follow-on drug R&D. % - no, it is biased towards follow-on drug R&D.
% TODO
% Acemoglu and Linn % Acemoglu and Linn
% - Market size in innovation % - Market size in innovation
@ -89,7 +140,10 @@ Among non-generics, a 1\% increase in potential market size
% Gupta % Gupta
% - Inperfect intellectual property rights in the pharmaceutical industry % - Inperfect intellectual property rights in the pharmaceutical industry
%\cite{GupaPhd2023} \cite{gupta_OneProduct_2020} discovered that uncertainty around which patents
might apply to a novel drug causes a delay in the entry of generics after
the primary patent has expired.
She found that this delay averages around 3 years.
% Agarwal and Gaule 2022 % Agarwal and Gaule 2022
% - Retrospective on impact from COVID-19 pandemic % - Retrospective on impact from COVID-19 pandemic

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