RT Journal Article
A1 Wang, Shirley V.
A1 Schneeweiss, Sebastian
T1 Data Checks Before Registering Study Protocols for Health Care Database Analyses
JF JAMA
JO JAMA
YR 2024
DO 10.1001/jama.2024.2988
VO 331
IS 17
SP 1445
OP 1446
SN 0098-7484
AB Many of the reasons why preregistration of randomized clinical trials (RCTs) has been embraced are also equally relevant for real-world evidence studies. 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.Professional societies and regulators recommend that protocols for real-world evidence studies on treatment effects be preregistered on repositories that provide time stamps and a persistent identifier (eg, osf.io/registries/rwe or ClinicalTrials.gov). Depositing a fully specified protocol at the time of registration addresses the concern that investigators who are unhappy with study findings may change study parameters to obtain more desirable results.
RD 5/20/2024
UL https://doi.org/10.1001/jama.2024.2988