Drug development should rely on fewer, larger trials, ex-Lilly exec Thompson tells FDA.

Executive Summary

DRUG DEVELOPMENT SHOULD RELY ON FEWER, LARGER STUDIES, ex-LILLY EXEC Leigh Thompson, MD/PhD, suggested at a Feb. 5 Center for Drug Evaluation & Research seminar. "We can get very few, large, well-designed, complex studies that have far more power in terms of the analyses we do and not have all of these small wasteful studies exposing people to placebo and doses that aren't any good," Thompson said. He advised FDA to "teach industry how to do a small number of studies" and to "coach people to think beyond mean and standard deviation."