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April 8, 2024

Data Checks Before Registering Study Protocols for Health Care Database Analyses

Author Affiliations
  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA. 2024;331(17):1445-1446. doi:10.1001/jama.2024.2988

Many of the reasons why preregistration of randomized clinical trials (RCTs) has been embraced are also equally relevant for real-world evidence studies.1 The fear that preliminary looks at study results may motivate changes in study design is amplified in real-world evidence studies that use electronic health records or insurance claims. This is because data on the study end points are usually already collected at the time of study conception.

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