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. 2021 Nov 1;4(11):e2133601.
doi: 10.1001/jamanetworkopen.2021.33601.

Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

Joshua D Wallach  1 , Reshma Ramachandran  2   3 , Till Bruckner  4   5 , Joseph S Ross  2   6
Affiliations

Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

Joshua D Wallach et al. JAMA Netw Open. .

Abstract

This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Wallach reported receiving funding from the US Food and Drug Administration (FDA). Dr Bruckner reported receiving grants from HealthWatch UK to conduct research into clinical trial transparency via TranspariMED and being the founder (an unpaid role) of the TranspariMED campaign. Dr Ross reported receiving research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology; from the FDA for the Yale University–Mayo Clinic Center Center for Excellence in Regulatory Science and Innovation program; from the Agency for Healthcare Research and Quality; from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH); and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. All funding and support were outside the scope of the present study. No other disclosures were reported.

References

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