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Published on: September 20, 2019
Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?
Anastasia Ivanova1, Zhiwei Zhang2, Laura Thompson2
1a Department of Biostatistics , The University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
Abstract:
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 nonresponders are re-randomized between placebo and active treatment. Data from the population of "all comers" and the subpopulations of placebo nonresponders 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 the potential uses of SPCD and TED in medical device trials.
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