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66 lines
3.2 KiB
TeX
66 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 propose a model of clinical trial progression that allows
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me to separate the effects of competing drugs (a strategic concern)
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and struggles recruiting (an operational concern).
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I also use a novel 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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to estimate the effects of competing drugs and difficulty recruiting.
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Similar to
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\cite{hwang_failure_2016}
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I focus on clinical trials in Phase III trials for drug compounds.
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Not all of these trials will be to test novel compounds, as many
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are trials to use previously approved compounds for new indications
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or in combination with other treatments.
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\end{document}
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