Clinical and Translational Science (Apr 2024)

Advancing the utilization of real‐world data and real‐world evidence in clinical pharmacology and translational research—Proceedings from the ASCPT 2023 preconference workshop

  • Jing Liu,
  • Karen Rowland‐Yeo,
  • Almut Winterstein,
  • Simon Dagenais,
  • Qi Liu,
  • Jeffrey S. Barrett,
  • Rui Zhu,
  • Cyrus Ghobadi,
  • Amita Datta‐Mannan,
  • Joy Hsu,
  • Sujatha Menon,
  • Mariam Ahmed,
  • Pooja Manchandani,
  • Paulien Ravenstijn

DOI
https://doi.org/10.1111/cts.13785
Journal volume & issue
Vol. 17, no. 4
pp. n/a – n/a

Abstract

Read online

Abstract Real‐world data (RWD) and real‐world evidence (RWE) are now being routinely used in epidemiology, clinical practice, and post‐approval regulatory decisions. Despite the increasing utility of the methodology and new regulatory guidelines in recent years, there remains a lack of awareness of how this approach can be applied in clinical pharmacology and translational research settings. Therefore, the American Society of Clinical Pharmacology & Therapeutics (ASCPT) held a workshop on March 21st, 2023 entitled “Advancing the Utilization of Real‐World Data (RWD) and Real‐World Evidence (RWE) in Clinical Pharmacology and Translational Research.” The work described herein is a summary of the workshop proceedings.