Why Should the FDA Focus on Pragmatic Clinical Research?

JAMA. 2024 Jul 9;332(2):103-104. doi: 10.1001/jama.2024.6227.
No abstract available

Plain language summary

This Viewpoint from the FDA discusses how pragmatic clinical research—assessment that uses real-world data, often in combination with research data, after initial marketing approval—can help in evaluation of new technologies, benefit research sites in underresourced settings, and better inform regulatory decisions and clinical practice.

Publication types

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

MeSH terms

  • Chronic Disease*
  • Drug Approval*
  • Humans
  • Pragmatic Clinical Trials as Topic*
  • Vereinigte Staaten
  • United States Food and Drug Administration*