Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and...

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Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Zhang, Audrey D., Skydel, Joshua J., Bartlett, Victoria L., Dhruva, Sanket S., Shah, Nilay D., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579227/
https://www.ncbi.nlm.nih.gov/pubmed/34751763
http://dx.doi.org/10.1001/jamanetworkopen.2021.33667
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author Wallach, Joshua D.
Zhang, Audrey D.
Skydel, Joshua J.
Bartlett, Victoria L.
Dhruva, Sanket S.
Shah, Nilay D.
Ross, Joseph S.
author_facet Wallach, Joshua D.
Zhang, Audrey D.
Skydel, Joshua J.
Bartlett, Victoria L.
Dhruva, Sanket S.
Shah, Nilay D.
Ross, Joseph S.
author_sort Wallach, Joshua D.
collection PubMed
description This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.
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spelling pubmed-85792272021-11-23 Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval Wallach, Joshua D. Zhang, Audrey D. Skydel, Joshua J. Bartlett, Victoria L. Dhruva, Sanket S. Shah, Nilay D. Ross, Joseph S. JAMA Netw Open Research Letter This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018. American Medical Association 2021-11-09 /pmc/articles/PMC8579227/ /pubmed/34751763 http://dx.doi.org/10.1001/jamanetworkopen.2021.33667 Text en Copyright 2021 Wallach JD et al. JAMA Network Open. 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
Wallach, Joshua D.
Zhang, Audrey D.
Skydel, Joshua J.
Bartlett, Victoria L.
Dhruva, Sanket S.
Shah, Nilay D.
Ross, Joseph S.
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title_full Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title_fullStr Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title_full_unstemmed Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title_short Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
title_sort feasibility of using real-world data to emulate postapproval confirmatory clinical trials of therapeutic agents granted us food and drug administration accelerated approval
topic Research Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579227/
https://www.ncbi.nlm.nih.gov/pubmed/34751763
http://dx.doi.org/10.1001/jamanetworkopen.2021.33667
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