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

JAMA Netw Open. 2021 Nov 1;4(11):e2133667. doi: 10.1001/jamanetworkopen.2021.33667.

Abstract

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.

Publication types

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

MeSH terms

  • Cross-Sectional Studies
  • Data Science / methods*
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / methods*
  • Feasibility Studies
  • Humans
  • Pragmatic Clinical Trials as Topic / legislation & jurisprudence
  • Pragmatic Clinical Trials as Topic / methods*
  • Product Surveillance, Postmarketing / methods*
  • United States
  • United States Food and Drug Administration