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FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Cocoros, Noelle M; Pokorney, Sean D; Haynes, Kevin; Garcia, Crystal; Al-Khalidi, Hussein R; Al-Khatib, Sana M; Archdeacon, Patrick; Goldsack, Jennifer C; Harkins, Thomas; Lin, Nancy D; Martin, David; McCall, Debbe; Nair, Vinit; Parlett, Lauren; Temple, Robert; McMahill-Walraven, Cheryl; Granger, Christopher B; Platt, Richard.
Afiliación
  • Cocoros NM; 1 Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Pokorney SD; 2 Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Haynes K; 3 HealthCore, Inc., Wilmington, DE, USA.
  • Garcia C; 1 Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Al-Khalidi HR; 4 Department of Biostatistics & Bioinformatics and Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Al-Khatib SM; 2 Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Archdeacon P; 5 US Food and Drug Administration, Silver Spring, MD, USA.
  • Goldsack JC; 6 The Clinical Trials Transformation Initiative, Durham, NC, USA.
  • Harkins T; 7 Comprehensive Health Insights, Humana Inc., Louisville, KY, USA.
  • Lin ND; 8 OptumInsight Life Sciences, Inc., Boston, MA, USA.
  • Martin D; 5 US Food and Drug Administration, Silver Spring, MD, USA.
  • McCall D; 9 Rowan Tree Perspectives Consulting, Murrieta, CA, USA.
  • Nair V; 7 Comprehensive Health Insights, Humana Inc., Louisville, KY, USA.
  • Parlett L; 3 HealthCore, Inc., Wilmington, DE, USA.
  • Temple R; 5 US Food and Drug Administration, Silver Spring, MD, USA.
  • McMahill-Walraven C; 10 Aetna Inc., Blue Bell, PA, USA.
  • Granger CB; 2 Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.
  • Platt R; 1 Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Clin Trials ; 16(1): 90-97, 2019 02.
Article en En | MEDLINE | ID: mdl-30445835
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Protocolos Clínicos / Ensayos Clínicos Pragmáticos como Asunto Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proyectos de Investigación / Protocolos Clínicos / Ensayos Clínicos Pragmáticos como Asunto Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido