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Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms.
Burcu, Mehmet; Dreyer, Nancy A; Franklin, Jessica M; Blum, Michael D; Critchlow, Cathy W; Perfetto, Eleanor M; Zhou, Wei.
Affiliation
  • Burcu M; Center for Observational and Real-World Evidence, Merck & Co., Inc., West Point, Pennsylvania, United States.
  • Dreyer NA; Real-World Solutions, IQVIA, Cambridge, Massachusetts.
  • Franklin JM; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
  • Blum MD; Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration, White Oak, Maryland.
  • Critchlow CW; Center for Observational Research, Amgen Inc., Thousand Oaks, California.
  • Perfetto EM; National Health Council, Washington, District of Columbia, and University of Maryland Baltimore (UMB), Baltimore, Maryland.
  • Zhou W; Center for Observational and Real-World Evidence, Merck & Co., Inc., West Point, Pennsylvania, United States.
Pharmacoepidemiol Drug Saf ; 29(10): 1228-1235, 2020 10.
Article in En | MEDLINE | ID: mdl-32162381
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Data Collection / Decision Making Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Pharmacoepidemiol Drug Saf Journal subject: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article Affiliation country: United States Country of publication: United kingdom
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Data Collection / Decision Making Type of study: Clinical_trials / Prognostic_studies Limits: Humans Language: En Journal: Pharmacoepidemiol Drug Saf Journal subject: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article Affiliation country: United States Country of publication: United kingdom