Uncontrolled Extensions of Clinical Trials and the Use of External Controls-Scoping Opportunities and Methods.

Wang, Ching-Yu; Berlin, Jesse A; Gertz, Barry; Davis, Kourtney; Li, Jie; Dreyer, Nancy A; Zhou, Wei; Seeger, John D; Santanello, Nancy; Winterstein, Almut G

Wang, Ching-Yu; Berlin, Jesse A; Gertz, Barry; Davis, Kourtney; Li, Jie; Dreyer, Nancy A; Zhou, Wei; Seeger, John D; Santanello, Nancy; Winterstein, Almut G.

Afiliação

Wang CY; Pharmaceutical Outcomes & Policy, Center for Drug Evaluation & Safety, University of Florida, Gainesville, Florida, USA.
Berlin JA; Epidemiology, Johnson & Johnson, Titusville, New Jersey, USA.
Gertz B; Blackstone Life Sciences, Cambridge, Massachusetts, USA.
Davis K; Global Epidemiology, Janssen R&D, Titusville, New Jersey, USA.
Li J; US Food and Drug Administration, Silver Spring, Maryland, USA.
Dreyer NA; Real-World Solutions, IQVIA, Cambridge, Massachusetts, USA.
Zhou W; Merck & Co., Inc., Kenilworth, New Jersey, USA.
Seeger JD; Optum, Boston, Massachusetts, USA.
Santanello N; Pharmacoepidemiology Consultant, New Hope, Pennsylvania, USA.
Winterstein AG; Pharmaceutical Outcomes & Policy, Center for Drug Evaluation & Safety, University of Florida, Gainesville, Florida, USA.

Clin Pharmacol Ther ; 111(1): 187-199, 2022 01.

Article em En | MEDLINE | ID: mdl-34165790

Assuntos

Grupos Controle; Viés; Bases de Dados Factuais; Humanos; Ensaios Clínicos Controlados Aleatórios como Assunto; Fatores de Risco

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Grupos Controle Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Prognostic_studies / Qualitative_research / Risk_factors_studies Limite: Humans Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2022 Tipo de documento: Article

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