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@ -50,7 +50,8 @@ safety and efficacy standards that the drug will be held too.
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For example, if a particular cancer is very deadly and does not respond well
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to current treatments, Phase I trials will enroll patients with that cancer,
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as opposed to the standard of enrolling healthy volunteers
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\cite{commissioner_DrugDevelopment_2020} to establish safe dosages.
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\cite{commissioner_drugdevelopmentprocess_2020}
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to establish safe dosages.
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The trial is more likely to be terminated early if the drug is unsafe or has no
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discernabile effect, therefore termination depends in part on a compound-disease
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interaction.
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@ -74,7 +75,7 @@ help the sponsor judge whether or not to continue the trial.
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Since Sep 27th, 2007 those who conduct clinical trials of FDA controlled
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drugs or devices on human subjects must register
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their trial at \url{ClinicalTrials.gov}
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(\cite{noauthor_fdaaa_nodate}).
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(\cite{anderson_fdadrugapproval_2022}).
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This involves submitting information on the expected enrollment and duration of
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trials, drugs or devices that will be used, treatment protocols and study arms,
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as well as contact information the trial sponsor and treatment sites.
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@ -84,13 +85,13 @@ When starting a new trial, the required information must be submitted
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After the initial submission, the data is briefly reviewed for quality and
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then the trial record is published and the trial is assigned a
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National Clinical Trial (NCT) identifier.
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\cite{noauthor_fdaaa_nodate}.
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(\cite{anderson_fdadrugapproval_2022}).
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Each trial's record is updated periodically, including a final update that must occur
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within a year of completing the primary objective, although exceptions are
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available for trials related to drug approvals or for trials with secondary
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objectives that require further observation\footnote{This rule came into effect in 2017}
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\cite{noauthor_fdaaa_nodate}.
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(\cite{anderson_fdadrugapproval_2022}).
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Other than the requirements for the the first and last submissions, all other
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updates occur at the discresion of the trial sponsor.
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Because the ClinicalTrials.gov website serves as a central point of information
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