updated citations and commented out duplicate lit review

claude_rewrite
Will King 1 year ago
parent a390dfd9a4
commit 25ae20af45

@ -46,13 +46,13 @@ completion of clinical trials\\ \small{Preliminary Draft}}
%--------------------------------------------------------------- %---------------------------------------------------------------
\subfile{sections/11_intro_and_lit} \subfile{sections/11_intro_and_lit}
%TODO: Remove this lit review section.
% \subfile{sections/05_LitReview}
%--------------------------------------------------------------- %---------------------------------------------------------------
\section{Literature Review}\label{SEC:LiteratureReview}
%---------------------------------------------------------------
\subfile{sections/05_LitReview}
\section{Clincal Trial Background}\label{SEC:ClinicalTrials} \section{Clincal Trial Background}\label{SEC:ClinicalTrials}
%---------------------------------------------------------------
\subfile{sections/12_clinical_trial_background} \subfile{sections/12_clinical_trial_background}

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

@ -51,7 +51,9 @@ marked as ``Terminated'' on
Note the information we obtain about the trial from the final status: Note the information we obtain about the trial from the final status:
``Withdrawn'', ``Terminated'', or ``Completed''. ``Withdrawn'', ``Terminated'', or ``Completed''.
Although \cite{khm} describes a clinical failure due to safety or efficacy as a Although
\cite{khmelnitskaya_competitionattritiondrug_2021}
describes a clinical failure due to safety or efficacy as a
\textit{scientific} failure, it is better described as a compound failure. \textit{scientific} failure, it is better described as a compound failure.
Discovering that a compound doesn't work as hoped is not a failure but the whole Discovering that a compound doesn't work as hoped is not a failure but the whole
purpose of the clinical trials process. purpose of the clinical trials process.

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