Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E.

Afiliação

Seltzer JH; ACI Clinical, Bala Cynwyd, PA. Electronic address: jseltzer@aciclinical.com.
Heise T; Cook Medical, Bloomington, IN.
Carson P; Veterans Affairs Medical Center, Washington, DC.
Canos D; Centers for Medicare and Medicaid Services, Baltimore, MD.
Hiatt JC; Kaiser Permanente, Pasedena, CA.
Vranckx P; Hartcenterum Hasselt, Belgium and European Clinical Research Institute, Rotterdam, The Netherlands.
Christen T; Boston Scientific Corporation, Boston, MA.
Cutlip DE; Beth Israel Deaconess Medical Center, Harvard Medical School and Baim Institute for Clinical Research, Boston, MA.

Am Heart J ; 190: 76-85, 2017 Aug.

Article em En | MEDLINE | ID: mdl-28760216

Assuntos

Pesquisa Biomédica; Doenças Cardiovasculares/terapia; Determinação de Ponto Final/normas; Equipamentos e Provisões; Vigilância de Produtos Comercializados/métodos; Humanos; Estados Unidos; United States Food and Drug Administration

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Doenças Cardiovasculares / Determinação de Ponto Final / Pesquisa Biomédica / Equipamentos e Provisões Idioma: En Ano de publicação: 2017 Tipo de documento: Article

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