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Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center.
Desai, Rishi J; Wang, Shirley V; Sreedhara, Sushama Kattinakere; Zabotka, Luke; Khosrow-Khavar, Farzin; Nelson, Jennifer C; Shi, Xu; Toh, Sengwee; Wyss, Richard; Patorno, Elisabetta; Dutcher, Sarah; Li, Jie; Lee, Hana; Ball, Robert; Dal Pan, Gerald; Segal, Jodi B; Suissa, Samy; Rothman, Kenneth J; Greenland, Sander; Hernán, Miguel A; Heagerty, Patrick J; Schneeweiss, Sebastian.
Afiliación
  • Desai RJ; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Wang SV; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Sreedhara SK; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Zabotka L; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Khosrow-Khavar F; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Nelson JC; Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
  • Shi X; Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
  • Toh S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
  • Wyss R; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Patorno E; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
  • Dutcher S; US Food and Drug Administration, Silver Spring, MD, USA.
  • Li J; US Food and Drug Administration, Silver Spring, MD, USA.
  • Lee H; US Food and Drug Administration, Silver Spring, MD, USA.
  • Ball R; US Food and Drug Administration, Silver Spring, MD, USA.
  • Dal Pan G; US Food and Drug Administration, Silver Spring, MD, USA.
  • Segal JB; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Suissa S; Departments of Epidemiology and Biostatistics, and Medicine, McGill University, Montreal, QC, Canada.
  • Rothman KJ; Boston University School of Public Health, Boston, MA, USA.
  • Greenland S; Department of Epidemiology and Department of Statistics, University of California, Los Angeles, CA, USA.
  • Hernán MA; CAUSALab and Departments of Epidemiology and Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.
  • Heagerty PJ; Department of Biostatistics, University of Washington, Seattle, WA, USA.
  • Schneeweiss S; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
BMJ ; 384: e076460, 2024 02 12.
Article en En | MEDLINE | ID: mdl-38346815

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Atención a la Salud Aspecto: Determinantes_sociais_saude Límite: Humans Idioma: En Revista: BMJ Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Atención a la Salud Aspecto: Determinantes_sociais_saude Límite: Humans Idioma: En Revista: BMJ Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos