CIOMS is pleased to announce that the consensus report of the CIOMS Working Group XIII on “Real-world Data and Real-world Evidence in Regulatory Decision Making” was published.

This report was developed to inform discussions about the use of Real-World Data (RWD) and Real-World Evidence (RWE) for regulatory and healthcare decision-making, including decisions to authorize a product for use, cover its costs (reimbursement), and determine its use for a particular patient (clinical use).

The report aims to:

  • Describe the potential use of RWE for decision-making.
  • Discuss RWD and its sources.
  • Highlight key scientific considerations in generating RWE.
  • Address ethical and governance issues in using RWD.

The intended audience includes medicinal product regulators, healthcare payers, healthcare and medicinal products industries, researchers, bioethicists, patients, and healthcare professionals.1

Access the full report here.

References

  1. Real-world data and real-world evidence in regulatory decision making • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES. (2024, June 24). COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES. https://cioms.ch/publications/product/real-world-data-and-real-world-evidence-in-regulatory-decision-making/

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred