| Literature DB >> 32941098 |
Anastasia Ivanova1, Elliot Israel2, Lisa M LaVange1, Michael C Peters3, Loren C Denlinger4, Wendy C Moore5, Leonard B Bacharier6, M Alison Marquis1, Nathan M Gotman1, Michael R Kosorok1, Chalmer Tomlinson1, David T Mauger7, Steve N Georas8, Rosalind J Wright9, Patricia Noel10, Gary L Rosner11, Praveen Akuthota12, Dean Billheimer13, Eugene R Bleecker13, Juan Carlos Cardet14, Mario Castro15, Emily A DiMango16, Serpil C Erzurum17, John V Fahy3, Merritt L Fajt18, Benjamin M Gaston19, Fernando Holguin20, Sonia Jain20, Nicholas J Kenyon21, Jerry A Krishnan22, Monica Kraft13, Rajesh Kumar23, Mark C Liu24, Ngoc P Ly2, James N Moy25, Wanda Phipatanakul26, Kristie Ross27, Lewis J Smith28, Stanley J Szefler29, W Gerald Teague30, Michael E Wechsler31, Sally E Wenzel18, Steven R White32.
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' 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.Entities:
Keywords: Master protocol; adaptive enrichment; compex; covariate adaptive randomization; platform trial; severe asthma
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Year: 2020 PMID： 32941098 PMCID： PMC7954787 DOI： 10.1080/10543406.2020.1821705
Source DB: PubMed Journal: J Biopharm Stat ISSN： 1054-3406 Impact factor: 1.051