@article{1aeb83f429b346ddabb654f3cab67427,
title = "The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations",
abstract = "The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients{\textquoteright} biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.",
keywords = "Master protocol, adaptive enrichment, compex, covariate adaptive randomization, platform trial, severe asthma",
author = "Anastasia Ivanova and Elliot Israel and LaVange, {Lisa M.} and Peters, {Michael C.} and Denlinger, {Loren C.} and Moore, {Wendy C.} and Bacharier, {Leonard B.} and Marquis, {M. Alison} and Gotman, {Nathan M.} and Kosorok, {Michael R.} and Chalmer Tomlinson and Mauger, {David T.} and Georas, {Steve N.} and Wright, {Rosalind J.} and Patricia Noel and Rosner, {Gary L.} and Praveen Akuthota and Dean Billheimer and Bleecker, {Eugene R.} and Cardet, {Juan Carlos} and Mario Castro and DiMango, {Emily A.} and Erzurum, {Serpil C.} and Fahy, {John V.} and Fajt, {Merritt L.} and Gaston, {Benjamin M.} and Fernando Holguin and Sonia Jain and Kenyon, {Nicholas J.} and Krishnan, {Jerry A.} and Monica Kraft and Rajesh Kumar and Liu, {Mark C.} and Ly, {Ngoc P.} and Moy, {James N.} and Wanda Phipatanakul and Kristie Ross and Smith, {Lewis J.} and Szefler, {Stanley J.} and Teague, {W. Gerald} and Wechsler, {Michael E.} and Wenzel, {Sally E.} and White, {Steven R.}",
note = "Publisher Copyright: {\textcopyright} 2020 Taylor & Francis Group, LLC.",
year = "2020",
doi = "10.1080/10543406.2020.1821705",
language = "English (US)",
volume = "30",
pages = "1026--1037",
journal = "Journal of biopharmaceutical statistics",
issn = "1054-3406",
publisher = "Taylor and Francis Ltd.",
number = "6",
}