Apr 15 Seminar – “Comparative Effectiveness Research: A Seasoned Regulator’s View”

April 15, 2014 by zrb8mf@virginia.edu

[Jordan Hall 1-14] Dr. Temple is deputy center director for clinical science at the FDA’s Center for Drug Evaluation and Research (CDER) and acting director of its Office of Drug Evaluation I (ODE-1). He received his medical degree from NYU School of Medicine in 1967 and joined CDER five years later. ODE-1 is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. He 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.