Minimal Residual Disease as a Surrogate Endpoint in Hematologic Cancer Trials

The Duke-Margolis Center for Health Policy invites you to attend a public workshop entitled, "Minimal Residual Disease as a Surrogate Endpoint in Hematologic Cancer Trials," which will take place on September 7th, 2016, at Hotel Monaco located at 700 F Street NW, Washington, DC 20004.

In order to support the goal of expediting the development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases (FDASIA 901(a)(c)), the Duke-Margolis Center, under a cooperative agreement with the U.S. Food and Drug Administration, will hold a public meeting to advance the discussion around the validation and use of Minimum Residual Disease (MRD) as a surrogate endpoint in clinical trials for hematologic malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, and multiple myeloma. The objectives for the day's discussion are to: 1) Discuss the regulatory background for use of MRD as a surrogate endpoint for regulatory decisions 2) Explore the statistical basis for demonstrating and validating surrogacy 3) Present the evidence available to support new surrogate endpoints for clinical trials in new treatments of certain hematological cancers.