(精编)Clinical Trials教学课件.ppt

? Scott Evans, Ph.D. and Lynne Peeples, M.S. Placebo Controlled Trial Limitations: If effective standard of care (SOC) treatment exists, then randomization to a placebo may not be ethical In order to get product approved, a sponsor does not necessarily need to show that the new product is better than another Instead it is necessary to show that the new product is “at least as good as” the SOC ? Scott Evans, Ph.D. and Lynne Peeples, M.S. Absence of Evidence is Not Evidence of Absence Thus we cannot conclude equivalence (or noninferiority simply because we fail to reject H0 ? Scott Evans, P