title: Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?
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.
authors.affiliation: a Department of Biostatistics , The University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.affiliation: b Division of Biostatistics , Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: b Division of Biostatistics , Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Thompson
authors.affiliation: b Division of Biostatistics , Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Ying
authors.initials: Y
authors.lastname: Yang
authors.affiliation: b Division of Biostatistics , Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Kotz
authors.affiliation: b Division of Biostatistics , Center for Devices and Radiological Health, Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Xin
authors.initials: X
authors.lastname: Fang
mesh_terms: D018795:Device Approval; D004864:Equipment and Supplies; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*
keywords: Medical device; SPCD; TED; placebo response; sequential parallel comparison design; two-way enriched design