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75 lines
3.5 KiB
TeX
75 lines
3.5 KiB
TeX
\documentclass[../Main.tex]{subfiles}
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\graphicspath{{\subfix{Assets/img/}}}
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\begin{document}
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Developing new, effective pharmaceutical compounds is a fundamentally
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difficult task.
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Starting with challenges identifying promising treatment targets and potential
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compounds to ensuring the drug can be properly delivered within the body, the
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scientific work that needs to succeede is massive.
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The regulatory and market conditions in which they exist add to this difficulty.
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For example, regulations are designed to reduce the number of drugs released
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to market with significan issues, such as in the case of VIOXX
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\cite{krumholz_whathavewe_2007}
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or the Perdue Pharma scandal
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\cite{officepublicaffairsjusticedepartment_2020}.
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These regulations, such as clinical trial standards
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\todo{add citation to clinical trials here},
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increase the costs of developing new drugs, adding to the business concerns
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already present, including competitors already in the market or close to
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entering and the overall demand to address a given condition.
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%begin discussing failures
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%I am thinking I'll discuss marketing and operational failures
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%I somehow need to step away from the drug development framing and soften it to
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%... what? drug investigation?
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From these general challenges we can begin to classify failures in drug
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development into a hierarchy of causes.
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\cite{khmelnitskaya_competitionattritiondrug_2021}
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described two general causes for a drug to exit the drug-development pipline,
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strategic exits and scientific failure.
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Similarly
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\cite{hwang_failure_2016}
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ascribe failues of Phase III trials to issues with safety,
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efficacy, or other (buisness) concerns.
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% The only one most ameniable to being targeted by policy
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% is those ``other concerns''.
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Although decisions to continue drug development are driven
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by long term profit analyses,
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pharmaceutical companies face short term operational challenges
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which can impede the development process.
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Some operational reasons given for why a trial was stopped include:
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\begin{itemize}
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\item Organizational challenges (Principle Investigator left institution,
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changes in research focus, staff shortages)
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\item Troubles with recruitment, (accural to slow/low, difficulty locating
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qualified participants, etc).
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\item Changes in standards of care.
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\item Sponsor withdraws support or provides insufficient financial support,
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e.g Funding runs out.
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\item Beginning or end of a pandemic.
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\end{itemize}
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% As an example, while a drug may have few competitors and
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% strong evidence of safety, difficulties recruiting trial participants may
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% prevent the clinical trials process from being completed successfully.
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Thus being able to isolate the effect of specific operational challenges from
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strategic decisions allows us to more accurately predict the intended or
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unintended effects of a given policy on clinical trials.
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In this work, I focus on separating the effects of enrollment and
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competing drugs on clinical trial completion, specifically Phase III trials.
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To do this, I create a dataset extracted from
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\url{ClinicalTrials.gov}
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that tracks individual clinical trials as they progress towards completion.
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I also introduce a novel causal model of individual clinical trial progression.
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Unlike previous research which generally focuses on the drug development
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pipeline through multiple phases, I restrict my investigation to modelling
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individual clinical trials.
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This restriction provides a way to separate the impact of different operational
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changes, specifically enrollment troubles and changes in the market.
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\end{document}
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