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44 lines
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44 lines
2.1 KiB
Plaintext
In 19xx the United States Food and Drug administration was created to "QUOTE".
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Since XXXX they have <Task relevant to what they do, i.e. how many drugs they have approved>.
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In 2007, they began requiring that drug developers register and publish clinical trials on \url{https://clinicaltrials.gov}.
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This provides a public mechanism where clinical trial sponsors are responsible to explain
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what they are trying to acheive and how it will be measured, as well as provide the public the ability to
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search and find trials that they might enroll in.
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%this has become part of multiple datasets (cortellis) used to evaluate what drugs might be entering the market soon.
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This brings up a question: can we use this public data on clinical trials to describe what effects their success or failure?
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In this work, I use updates to records on \url{https://ClinicalTrials.gov} to separate the effect of
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%Describe how clinical trials fit into the drug development landscape and how they proceed
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Clinical trials are a required part of drug development.
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Not only does the FDA require that a series of clinical trials demonstrate sufficient safety and efficacy of
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a novel pharmaceutical compound or device, producers of derivative medicines may be required to ensure that
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their generic small molecule compound -- such as ibuprofen or levothyroxine -- matches the
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performance of the originiator drug if delivery or dosage is changed.
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For large molecule generics (termed biosimilars) such as Adalimumab
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(Brand name Humira, with biosimilars Abrilada, Amjevita, Cyltezo, Hadlima, Hulio,
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Hyrimoz, Idacio, Simlandi, Yuflyma, and Yusimry),
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the biosimilars are required to prove they have similar efficacy and safety to the
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reference drug.
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When registering these clinical trials
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% discuss how these are registered and what data is published.
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% Include image and discuss stages
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% Discuss challenges faced
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% Introduce my work
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At least in the world of drug development, these trials take place in a wider framework of Phases
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% Now talk about phases, begin introducing work by Chris Adams
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% Lead into lit review
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% Causality
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% Data
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% Economic Model
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% Results
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% Conclusion
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