Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint <scp>ISPOR‐ISPE</scp> Special Task Force on real‐world evidence in health care decision making
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- Marc L. Berger
- New York City NY USA
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- Harold Sox
- Patient‐Centered Outcomes Research Institute Washington DC USA
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- Richard J. Willke
- International Society for Pharmacoeconomics and Outcomes Research Lawrenceville NJ USA
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- Diana L. Brixner
- University of Utah Salt Lake City UT USA
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- Hans‐Georg Eichler
- European Medicines Agency London UK
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- Wim Goettsch
- Zorginstituut Nederland and University of Utrecht Utrecht The Netherlands
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- David Madigan
- Columbia University New York City NY USA
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- Amr Makady
- Zorginstituut Nederland and University of Utrecht Utrecht The Netherlands
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- Sebastian Schneeweiss
- Brigham and Women's Hospital Harvard Medical School Boston MA USA
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- Rosanna Tarricone
- Bocconi University Milan Italy
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- Shirley V. Wang
- Brigham and Women's Hospital Harvard Medical School Boston MA USA
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- John Watkins
- Premera Blue Cross Mountlake Terrace WA USA
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- C. Daniel Mullins
- University of Maryland Baltimore MD USA
Description
<jats:title>Abstract</jats:title><jats:sec><jats:title>Purpose</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>
Journal
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- Pharmacoepidemiology and Drug Safety
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Pharmacoepidemiology and Drug Safety 26 (9), 1033-1039, 2017-09
Wiley
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Details 詳細情報について
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- CRID
- 1360292620506532736
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- DOI
- 10.1002/pds.4297
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- ISSN
- 10991557
- 10538569
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- Data Source
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- Crossref