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63 lines
3.2 KiB
TeX
63 lines
3.2 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 ... 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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\cite{hwang_failure_2016}
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described failues of Phase III trials in a similar way,
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ascribing drug development failures 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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% 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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For example, even with few competitors and strong safety evidence, recruitment difficulties can still derail a drug's clinical trial process.
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\todo{Clean up that hypothetical, it doesn't seem clean}
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Thus being able to isolate the effect of operational challenges from
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strategic decisions allows us to predict the intended or unintended effects
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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
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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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as well as a novel causal model of individual clinical trial progression.
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Unlike previous research which is focused on the drug development pipeline, I
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restrict my investigation to modelling individual clinical trials.
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The goal of this restriction is to provide a way to predict the impact
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of changes that affect enrollment independent of other confounding effects.
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\end{document}
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