Department of Biostatistics Seminar/Workshop Series

Biostatistics for Regulators and Politicians: Why Statisticians Need to Be Activists!

Yu Shyr, PhD

Professor of Biostatistics, Director of Cancer Biostatistics Center, Vanderbilt-Ingram Cancer Center

Wednesday, May 19, 1:30-2:30pm, MRBIII Conference Room 1220

The U.S. Food & Drug Administration uses 49 committees and panels to obtain independent expert advice on matters of science and policy, including specific regulatory decisions (e.g., product approvals) and general matters of policy (e.g., regulations and guidance). Members of Congress also seek expert advice at times, but receive far more input – often of questionable expertise – from lobbyists. Dr. Shyr will recount his experiences during an AACi/AACR/ASCO Capitol Hill Lobby Day as well as his experiences as a standing member of an FDA advisory committee, including the importance of providing an informed and expert statistical perspective to the people who govern critical issues. The talk will focus on two case studies: an FDA advisory committee meeting in November 2009 and the AACi/AACR/ASCO Capitol Hill Lobby Day on May 5, 2010.