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Designing effective drug and device development programs for hospitalized heart failure: a proposal for pretrial registries.
Greene, Stephen J; Shah, Ami N; Butler, Javed; Ambrosy, Andrew P; Anker, Stefan D; Chioncel, Ovidiu; Collins, Sean P; Dinh, Wilfried; Dunnmon, Preston M; Fonarow, Gregg C; Lam, Carolyn S P; Mentz, Robert J; Pieske, Burkert; Roessig, Lothar; Rosano, Giuseppe M C; Sato, Naoki; Vaduganathan, Muthiah; Gheorghiade, Mihai.
Afiliación
  • Greene SJ; Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL.
  • Shah AN; Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL.
  • Butler J; Division of Cardiology, Emory University, Atlanta, GA.
  • Ambrosy AP; Department of Medicine, Stanford University School of Medicine, Stanford, CA.
  • Anker SD; Department of Innovative Clinical Trials, University Medical Centre Göttingen, Göttingen, Germany.
  • Chioncel O; Institute of Emergency for Cardiovascular Diseases Prof. C.C.Iliescu, University of Medicine Carol Davila, Bucuresti, Romania.
  • Collins SP; Department of Emergency Medicine, Vanderbilt University, Nashville, TN.
  • Dinh W; Department of Cardiology, Witten University, Witten, Germany; Global Drug Discovery, Clinical Sciences, Bayer Pharma AG, Berlin, Germany.
  • Dunnmon PM; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Fonarow GC; Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, CA.
  • Lam CS; National University Health System, Singapore.
  • Mentz RJ; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
  • Pieske B; Department of Cardiology, Graz, Austria.
  • Roessig L; Global Clinical Development, Bayer Pharma AG, Berlin, Germany.
  • Rosano GM; Division of Cardiology, IRCC San Raffaele, Rome, Italy.
  • Sato N; Internal Medicine, Cardiology, and Intensive Care Medicine, Nippon Medical School Musashi-Kosugi Hospital, Kanagawa, Japan.
  • Vaduganathan M; Department of Medicine, Massachusetts General Hospital, Boston, MA.
  • Gheorghiade M; Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: m-gheorghiade@northwestern.edu.
Am Heart J ; 168(2): 142-9, 2014 Aug.
Article en En | MEDLINE | ID: mdl-25066552
Recent international phase III clinical trials of novel therapies for hospitalized heart failure (HHF) have failed to improve the unacceptably high postdischarge event rate. These large studies have demonstrated notable geographic and site-specific variation in patient profiles and enrollment. Possible contributors to the lack of success in HHF outcome trials include challenges in selecting clinical sites capable of (1) providing adequate numbers of appropriately selected patients and (2) properly executing the study protocol. We propose a "pretrial registry" as a novel tool for improving the efficiency and quality of international HHF trials by focusing on the selection and cultivation of high-quality sites. A pretrial registry may help assess a site's ability to achieve adequate enrollment of the target patient population, integrate protocol requirements into clinical workflow, and accomplish appropriate follow-up. Although such a process would be associated with additional upfront resource investment, this appropriation may be modest in comparison with the downstream costs associated with maintenance of poorly performing sites, failed clinical trials, and the global health and economic burden of HHF. This review is based on discussions between scientists, clinical trialists, and regulatory representatives regarding methods for improving international HHF trials that took place at the United States Food and Drug Administration on January 12th, 2012.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sistema de Registros / Ensayos Clínicos Fase II como Asunto / Terapias en Investigación / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Am Heart J Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sistema de Registros / Ensayos Clínicos Fase II como Asunto / Terapias en Investigación / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Am Heart J Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos