• Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, and Daniel MullinsCCUniversity of Maryland, Baltimore, MD, USA..
• New York City, NY, USA.
• Pharmacoepidemiol Drug Saf. 2017 Sep 1; 26 (9): 1033-1039.

PurposeReal-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making.MethodsThe International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations.ResultsThe ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making.ConclusionThe focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.© 2017 The Authors. Pharmacoepidemiology & Drug Safety published by John Wiley & Sons Ltd.

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