Good Practices for Real‐World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐World Evidence in Health Care Decision Making

Real‐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. The International Society for Pharmacoeco...

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Bibliographic Details
Published in:Value in health Vol. 20; no. 8; pp. 1003 - 1008
Main Authors: Berger, Marc L., Sox, Harold, Willke, Richard J., Brixner, Diana L., Eichler, Hans‐Georg, Goettsch, Wim, Madigan, David, Makady, Amr, Schneeweiss, Sebastian, Tarricone, Rosanna, Wang, Shirley V., Watkins, John, Mullins, C. Daniel
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01.09.2017
Elsevier Science Ltd
Subjects:
Advisory Committees
Clinical outcomes
Clinical trials
comparative effectiveness
Comparative Effectiveness Research - methods
Data analysis
Decision makers
Decision Making
Delivery of Health Care - methods
Economics
Evidence
Evidence-Based Medicine - methods
Grammatical aspect
guidelines
Guidelines as Topic
Health care
Health services
Humans
Incentives
Medical decision making
Medical research
Observational studies
Peer review
pharmacoepidemiology
Pharmacology
real‐world data
Registration
Reproducibility of Results
Research Design
Stakeholders
Task forces
treatment effectiveness
Treatment outcomes
comparative effectiveness
guidelines
decision making
real‐world data
pharmacoepidemiology
treatment effectiveness
ISSN:1098-3015, 1524-4733, 1524-4733
Online Access:Get full text
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Summary:Real‐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. The 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. The 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. The 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.
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ISSN:1098-3015
1524-4733
1524-4733
DOI:10.1016/j.jval.2017.08.3019