Time From Submission of Johns Hopkins University Trial Results to Posting on ClinicalTrials.gov

Abstract

The US Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that applicable clinical trials (ACTs) submit results to ClinicalTrials.gov within 1 year of completion. ClinicalTrials.gov identifies trials that likely meet this definition as probable ACTs (pACTs). A complementary National Institutes of Health (NIH) policy requires that nonapplicable clinical trials (non-ACTs) funded by grants submitted to NIH from January 18, 2017, also submit results. After investigators submit results, the National Library of Medicine reviews their quality and may request changes by sending “comments” to investigators. Whether the NIH comments on records, the NIH must post results within 30 calendar days of first submission; the FDAAA makes no exemption for quality review time, and the NIH has not implemented a process for posting records that do not pass review. We evaluated the time between submitting and public posting of results.