Complexities in drug trials: enrichment, biomarkers and surrogates. Interview with Robert Temple

Dr Robert Temple is Director of the Office of Medical Policy of FDA's Center for Drug Evaluation and Research and is also Acting Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office's establishment in 1995. Dr Temple received his medical degree from the New York University School of Medicine in 1967. In 1972, he joined CDER as a review 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. In his current position, Dr Temple oversees ODE-1, which is responsible for the regulation of cardio-renal, neuropharmacologic and psychopharmacologic drug products. He also oversees The Office of Medical Policy, which is responsible for regulation of promotion through the Division of Drug Marketing, Advertising and Communication and for assessing quality of clinical trials. Dr Temple has a long-standing interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response and trials using 'enrichment' designs.