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The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.
Ivanova, Anastasia; Israel, Elliot; LaVange, Lisa M; Peters, Michael C; Denlinger, Loren C; Moore, Wendy C; Bacharier, Leonard B; Marquis, M Alison; Gotman, Nathan M; Kosorok, Michael R; Tomlinson, Chalmer; Mauger, David T; Georas, Steve N; Wright, Rosalind J; Noel, Patricia; Rosner, Gary L; Akuthota, Praveen; Billheimer, Dean; Bleecker, Eugene R; Cardet, Juan Carlos; Castro, Mario; DiMango, Emily A; Erzurum, Serpil C; Fahy, John V; Fajt, Merritt L; Gaston, Benjamin M; Holguin, Fernando; Jain, Sonia; Kenyon, Nicholas J; Krishnan, Jerry A; Kraft, Monica; Kumar, Rajesh; Liu, Mark C; Ly, Ngoc P; Moy, James N; Phipatanakul, Wanda; Ross, Kristie; Smith, Lewis J; Szefler, Stanley J; Teague, W Gerald; Wechsler, Michael E; Wenzel, Sally E; White, Steven R.
Afiliação
  • Ivanova A; University of North Carolina, Chapel Hill, NC.
  • Israel E; Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
  • LaVange LM; University of North Carolina, Chapel Hill, NC.
  • Peters MC; University of California, San Francisco.
  • Denlinger LC; University of Wisconsin, Madison.
  • Moore WC; Wake Forest School of Medicine, Winston-Salem, NC.
  • Bacharier LB; Vanderbilt University, Nashville, TN.
  • Marquis MA; University of North Carolina, Chapel Hill, NC.
  • Gotman NM; University of North Carolina, Chapel Hill, NC.
  • Kosorok MR; University of North Carolina, Chapel Hill, NC.
  • Tomlinson C; University of North Carolina, Chapel Hill, NC.
  • Mauger DT; Penn State University, Hershey, PA.
  • Georas SN; University of Rochester, Rochester, NY.
  • Wright RJ; Icahn School of Medicine at Mount Sinai, New York, NY.
  • Noel P; Division of Lung Diseases, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.
  • Rosner GL; Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.
  • Akuthota P; University of California, San Diego.
  • Billheimer D; Asthma and Airway Disease Research Center, University of Arizona, Tucson.
  • Bleecker ER; Asthma and Airway Disease Research Center, University of Arizona, Tucson.
  • Cardet JC; University of South Florida, Tampa, FL.
  • Castro M; University of Kansas School of Medicine, Kansas City.
  • DiMango EA; Columbia University, New York, NY.
  • Erzurum SC; Cleveland Clinic, Cleveland, OH.
  • Fahy JV; University of California, San Francisco.
  • Fajt ML; University of Pittsburgh, Pittsburgh, PA.
  • Gaston BM; Wells Center for Pediatric Research, Indiana University, Indianapolis.
  • Holguin F; University of Colorado School of Medicine, Aurora.
  • Jain S; University of Colorado School of Medicine, Aurora.
  • Kenyon NJ; University of California, Davis.
  • Krishnan JA; University of Illinois, Chicago.
  • Kraft M; Asthma and Airway Disease Research Center, University of Arizona, Tucson.
  • Kumar R; Lurie Children's Hospital, Chicago, IL.
  • Liu MC; Johns Hopkins University, Baltimore, MD.
  • Ly NP; Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
  • Moy JN; Rush University Medical Center, Chicago, IL.
  • Phipatanakul W; Boston Children's Hospital and Harvard Medical School, Boston, MA.
  • Ross K; UH Rainbow Babies and Children's Hospitals, Cleveland, OH.
  • Smith LJ; Northwestern University, Chicago, IL.
  • Szefler SJ; Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO.
  • Teague WG; University of Virginia, Charlottesville.
  • Wechsler ME; National Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.
  • Wenzel SE; University of Pittsburgh, Pittsburgh, PA.
  • White SR; University of Chicago, Chicago, IL.
J Biopharm Stat ; 30(6): 1026-1037, 2020 11 01.
Article em En | MEDLINE | ID: mdl-32941098
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies / Guideline Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article