Department of Biostatistics Seminar/Workshop Series

Statistics and Drug Regulations in the US

Lisa M. LaVange, PhD

Office of Biostatistics, Office of Translational Sciences (OTS)

Center for Drug Evaluation and Research (CDER)

US FDA

This talk will be a reflection on the importance of statistics in US drug regulation. I will look back to the early days of the FDA and describe the evolution of biostatistics as a discipline in the Center for Drug Evaluation and Research (CDER). The growth of biostatistics in size – from a single CDER division to an office of over 190 employees, and in mission – from a group focused on fundamental concepts of clinical trials to a group now engaged in numerous and varied aspects of drug development and both pre- and post-market regulation – will be briefly described. Moving to the present day, I will give a broad overview of the statistical issues and review challenges we face now, highlighting areas where statisticians make significant contributions through problem solving and effective leadership. Areas that hold opportunity for statisticians to provide innovation in drug regulation in the future will also be described.