Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021

This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.

Detalles Bibliográficos
Autores principales: Deshmukh, Anjali D., Kesselheim, Aaron S., Rome, Benjamin N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10066454/
https://www.ncbi.nlm.nih.gov/pubmed/37000434
http://dx.doi.org/10.1001/jamahealthforum.2023.0217
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author Deshmukh, Anjali D.
Kesselheim, Aaron S.
Rome, Benjamin N.
author_facet Deshmukh, Anjali D.
Kesselheim, Aaron S.
Rome, Benjamin N.
author_sort Deshmukh, Anjali D.
collection PubMed
description This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.
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spelling pubmed-100664542023-04-02 Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021 Deshmukh, Anjali D. Kesselheim, Aaron S. Rome, Benjamin N. JAMA Health Forum Research Letter This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration. American Medical Association 2023-03-31 /pmc/articles/PMC10066454/ /pubmed/37000434 http://dx.doi.org/10.1001/jamahealthforum.2023.0217 Text en Copyright 2023 Deshmukh AD et al. JAMA Health Forum. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Research Letter
Deshmukh, Anjali D.
Kesselheim, Aaron S.
Rome, Benjamin N.
Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title_full Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title_fullStr Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title_full_unstemmed Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title_short Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
title_sort timing of confirmatory trials for drugs granted accelerated approval based on surrogate measures from 2012 to 2021
topic Research Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10066454/
https://www.ncbi.nlm.nih.gov/pubmed/37000434
http://dx.doi.org/10.1001/jamahealthforum.2023.0217
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AT romebenjaminn timingofconfirmatorytrialsfordrugsgrantedacceleratedapprovalbasedonsurrogatemeasuresfrom2012to2021

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