The FDA’s Center for Drug Evaluation and Research (CDER) has appointed Dr. Frank Harrell, professor of biostatistics at Vanderbilt University Medical Center, as a senior biostatistics advisor to the Office of the Center Director under the Intergovernmental Personnel Act (IPA) Mobility Program. CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards, and available to patients.
Under this appointment, Harrell will serve as a senior advisor to CDER on innovative and novel models for biostatistical analysis to facilitate the regulatory drug review in therapeutic areas with underserved populations or unmet medical needs. Harrell will advise the center on advanced approaches to drug regulatory pathways, optimization of regulatory science models, and complex statistical analysis methodologies and clinical trial designs.
The IPA Mobility Program provides for the temporary assignment of personnel between the federal government and state and local governments, colleges and universities, Indian tribal governments, federally funded research and development centers, and other eligible organizations. The program is a critical tool that allows federal agencies to access academicians or clinical experts on a part-time basis to bolster existing or new initiatives.
Harrell previously served as an advisor to the FDA CDER Office of Biostatistics from 2016 to 2020 and has been a long-time consultant to the FDA. "I am excited to serve in this important role at the request of the CDER director as part of my VUMC appointment, and look forward to contributing to making clinical trials more efficient and flexible, as well as to fostering development of statistical methods to analyze new types of patient outcomes in therapeutic clinical trials. My last two years of working with my Vanderbilt biostatistics and VICTR colleagues on the design and analysis of many high-profile Vanderbilt-led COVID-19 clinical trials has given me experience and ideas that I plan to put into use at FDA."
