Clinical Trials Registration and Results Summary Reporting Policy
Transparency in clinical trials is improved through the registration of the trial on a publicly available database and website such as www.clinicaltrials.gov.
There are varying registration and results summary reporting requirements. For example:
· U.S. Department of Health and Human Services issued a Final Rule for Clinical Trial Registration and Results Information Submission (codified in 42 CFR 11) that requires certain clinical trials to submit registration information and results summary to ClinicalTrials.gov.
· The NIH has a complementary policy requiring protocol registration and results summary reporting for all NIH-funded studies.
· The ICMJE has a clinical trial registration policy that recommends that medical journal editors require registration of clinical trials in a public trials registry as a condition for publication.
· The European Union (EU) regulation No 536/2014 requires that clinical trials be recorded in publicly accessible database.
In addition to protocol registration and summary results reporting, it is also worth mentioning that the revised Common Rule (2018 Requirements) at 45 CFR 46, Subpart A, includes a requirement for posting informed consent forms for clinical trials (this is discussed in the Revised Common Rule section below). Posting consent forms is another step towards increasing transparency in research.