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

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

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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data*
  • Drug Approval / statistics & numerical data*
  • Drug Industry / methods
  • Humans
  • Product Surveillance, Postmarketing / statistics & numerical data
  • Product Surveillance, Postmarketing / trends*
  • United States
  • United States Food and Drug Administration