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

Affiliations

• ¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02120, USA.
• ² Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
• ³ Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
• ⁴ Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
• ⁵ US Food and Drug Administration, Silver Spring, MD, USA.
• ⁶ Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
• ⁷ Departments of Epidemiology and Biostatistics, and Medicine, McGill University, Montreal, QC, Canada.
• ⁸ Boston University School of Public Health, Boston, MA, USA.
• ⁹ Department of Epidemiology and Department of Statistics, University of California, Los Angeles, CA, USA.
• ¹⁰ CAUSALab and Departments of Epidemiology and Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.
• ¹¹ Department of Biostatistics, University of Washington, Seattle, WA, USA.