An Application of the Causal Roadmap in Two Safety Monitoring Case Studies: Covariate-Adjustment and Outcome Prediction using Electronic Health Record Data

Autor: Williamson, Brian D, Wyss, Richard, Stuart, Elizabeth A, Dang, Lauren E, Mertens, Andrew N, Wilson, Andrew, Gruber, Susan

Real-world data, such as administrative claims and electronic health records, are increasingly used for safety monitoring and to help guide regulatory decision-making. In these settings, it is important to document analytic decisions transparently an

Externí odkaz: http://arxiv.org/abs/2305.07564

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A causal roadmap for generating high-quality real-world evidence.

Autor: Dang LE; Department of Biostatistics, University of California, Berkeley, CA, USA., Gruber S; TL Revolution, Cambridge, MA, USA., Lee H; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Dahabreh IJ; CAUSALab, Department of Epidemiology and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA., Stuart EA; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Williamson BD; Biostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA., Wyss R; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Díaz I; Division of Biostatistics, Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA., Ghosh D; Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA., Kıcıman E; Microsoft Research, Redmond, WA, USA., Alemayehu D; Global Biometrics and Data Management, Pfizer Inc., New York, NY, USA., Hoffman KL; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA., Vossen CY; Syneos Health Clinical Solutions, Amsterdam, The Netherlands., Huml RA; Syneos Health Clinical Solutions, Morrisville, NC, USA., Ravn H; Novo Nordisk, Søborg, Denmark., Kvist K; Novo Nordisk, Søborg, Denmark., Pratley R; AdventHealth Translational Research Institute, Orlando, FL, USA., Shih MC; Cooperative Studies Program Coordinating Center, VA Palo Alto Health Care System, Palo Alto, CA, USA.; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA., Pennello G; Division of Imaging Diagnostics and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA., Martin D; Global Real World Evidence Group, Moderna, Cambridge, MA, USA., Waddy SP; National Center for Advancing Translational Sciences, Bethesda, MD, USA., Barr CE; Graticule Inc., Newton, MA, USA.; Adaptic Health Inc., Palo Alto, CA, USA., Akacha M; Novartis Pharma AG, Basel, Switzerland., Buse JB; Division of Endocrinology, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA., van der Laan M; Department of Biostatistics, University of California, Berkeley, CA, USA., Petersen M; Department of Biostatistics, University of California, Berkeley, CA, USA.

Publikováno v: Journal of clinical and translational science [J Clin Transl Sci] 2023 Sep 22; Vol. 7 (1), pp. e212. Date of Electronic Publication: 2023 Sep 22 (Print Publication: 2023).