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46 lines
2.0 KiB
TeX
46 lines
2.0 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 novel, safe, and effective pharmaceutical compounds is difficult.
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Starting with challenges identifying promising treatment targets and potential compounds, to ensuring the drug can be properly delivered within the body, the scientific work that needs to go well 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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This work is the first that endeavors to separate the causal effect
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of an operational concern (participant enrollment) from that of strategic
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concerns (market size and competitors in the market)
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on individual clinical trials.
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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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Understanding both why and how the development of drugs fail -- for both
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novel and derivative pharmaceuticals -- is key to ensuring that both innovation
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and availability are maximized.
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\end{document}
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