Randomized clinical trials (RCTs) are the building blocks of an evidence-based approach to medicine and surgery. These trials are used as trusted sources of evidence when designing clinical practice guidelines. It is therefore expected that their results are trustworthy and that their conclusions can be verified. Randomized clinical trial data sharing (ie, sharing statistical codes, study protocols, and individual participant data) holds promise for enhancing transparency and maximizing the value of research.
1 Data sharing is supported by patients who also want to share their data in a responsible and secure manner.
2 In 2018, the International Committee of Medical Journal Editors (ICMJE) required that manuscripts submitted to ICMJE journals as of July 1, 2018, must contain a data sharing statement if they are reporting the results of an RCT. If a trial began enrolling participants on or after January 1, 2019, the article must also include a data sharing plan in the trial’s registration.
3 The ICMJE considers that “it is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.”
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