Dr. Robert Temple is the Senior Advisor for Clinical Science in CDER’s Office of the Center Director where he serves as the Center executive-level leader on the clinical evaluation of drugs and related scientific and policy matters. He is also the Senior Advisor in the Immediate Office of the Office of New Drugs (OND) where he advises on policy, guidance and difficult problems in drug development and their regulation covered by the Office.
Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972, he joined CDER as a Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.
Dr. Temple most recently served as CDER’s Deputy Center Director for Clinical Science. Before becoming Senior Advisor in OND, Dr. Temple was the Acting Deputy Director of OND’s Office of Drug Evaluation-I, which was responsible for the regulation of cardiovascular and renal, neurology, and psychiatry drug products. He served in this capacity for more than 23 years—since the office’s establishment in 1995.
Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation and active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. He has been involved in the development of many International Conference on Harmonization (ICH) guidelines and numerous FDA guidances, including ones on study enrichment and on issues related to the design and interpretation of non-inferiority studies.