The External Evidence Methods (EEM) Framework project aims to establish a more predictable pathway for use of EEM, such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods for evidence fusion from data external to a clinical trial. External trial data includes but is not limited to Real-World Data (RWD), Real-World Evidence (RWE), engineering modeling and simulation, and similar device clinical trial data to support regulatory medical device decisions and other stakeholder decisions.

The MDIC EEM working group is now drafting an EEM Framework, and is out for Public Comment until Monday, February 22, 2021 at 5 pm ET. If you would like to learn more about the project as well as explore the opportunities for collaborating on this project, please contact us at

MDIC EEM Project Leads:

  • Ram Tiwari, Director, Division of Biostatistics, Office of Clinical Evidence & Analysis | CDRH, FDA
  • Ted Lystig, Senior Director, Corporate Biostatistics | Medtronic
  • Vandana Bhatia, Assistant Director, Division of Biostatistics, Office of Clinical Evidence and Analysis | CDRH, FDA
Current as of January 29, 2021
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