Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics-Reference-Cited by-同舟云学术

Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics

Published:2023-11-01 Issue:11 Volume:183 Page:1271
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Janda Guneet S.¹,Wallach Joshua D.²,Dhodapkar Meera M.¹,Ramachandran Reshma³⁴,Ross Joseph S.⁵⁶⁷

Affiliation:

1. Yale School of Medicine, New Haven, Connecticut

2. Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia

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

4. Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut

5. Section of General Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

6. Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut

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

Abstract

This cross-sectional study evaluates the supporting clinical trials for supplemental new drug applications and supplemental biologics license applications from 2017 to 2019.

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Link

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2810307/jamainternal_janda_2023_ld_230029_1698160497.59518.pdf

Reference6 articles.

1. Target trial emulation: a framework for causal inference from observational data.;Hernán;JAMA,2022

2. Emulation of randomized clinical trials with nonrandomized database analyses: results of 32 clinical trials.;Wang;JAMA,2023

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

4. Feasibility of using real-world data to emulate postapproval confirmatory clinical trials of therapeutic agents granted US Food and Drug Administration accelerated approval.;Wallach;JAMA Netw Open,2021

5. Characteristics of clinical studies used for US Food and Drug Administration supplemental indication approvals of drugs and biologics, 2017 to 2019.;Dhodapkar;JAMA Netw Open,2021

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