Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval-Reference-Cited by-同舟云学术

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

Published:2021-11-09 Issue:11 Volume:4 Page:e2133667
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Wallach Joshua D.¹,Zhang Audrey D.²,Skydel Joshua J.³,Bartlett Victoria L.⁴,Dhruva Sanket S.⁵⁶,Shah Nilay D.⁷,Ross Joseph S.⁸⁹¹⁰

Affiliation:

1. Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut

2. Duke University Health System, Durham, North Carolina

3. Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

4. Yale School of Medicine, New Haven, Connecticut

5. Section of Cardiology, San Francisco Veterans Affairs Health Care System, San Francisco, California

6. Department of Medicine, School of Medicine, University of California, San Francisco

7. Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota

8. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

9. National Clinician Scholars Program, Yale School of Medicine, Department of Internal Medicine, New Haven, Connecticut

10. Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2785882/wallach_2021_ld_210243_1635436980.91764.pdf

Reference6 articles.

1. Fulfilling the mandate of the US Food and Drug Administration’s accelerated approval pathway: the need for reforms.;Gyawali;JAMA Intern Med,2021

2. Feasibility of using real-world data to replicate clinical trial evidence.;Bartlett;JAMA Netw Open,2019

3. Timeliness of postmarket studies for new pharmaceuticals approved between 2009 and 2012: a cross-sectional analysis.;Wallach;J Gen Intern Med,2019

4. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.;Skydel;Clin Trials,2021

5. The electronic health record as a clinical trials tool: opportunities and challenges.;Bertagnolli;Clin Trials,2020

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