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, to be released for public comment by December 2020. 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