Scientific Publications by FDA Staff

J Biopharm Stat 2016;26(1):167-77

Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?

Ivanova A, Zhang Z, Thompson L, Yang Y, Kotz RM, Fang X

Sequential parallel comparison design (SPCD) was proposed for trials with high placebo response. In the first stage of SPCD subjects are randomized between placebo and active treatment. In the second stage placebo non-responders are re-randomized between placebo and active treatment. Data from the population of "all comers" and the sub-populations of placebo non-responders then combined to yield a single p-value for treatment comparison. Two-way enriched design (TED) is an extension of SPCD where active treatment responders are also re-randomized between placebo and active treatment in Stage 2. This article investigates potential uses of SPCD and TED in medical device trials.