Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics

JAMA. 2023 Dec 26;330(24):2392-2394. doi: 10.1001/jama.2023.21958.
No abstract available

Plain language summary

This study evaluates whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials as Topic*
  • Demography*
  • Diffusion of Innovation
  • Drug Approval*
  • Humans
  • Medical Oncology
  • Neoplasms* / therapy
  • Time Factors
  • United States
  • United States Food and Drug Administration