NIH Clinical Trials Reporting Compliance: A Shared Commitment

As the largest public funder of clinical trials in the United States, NIH is committed to the timely dissemination of clinical trial results information so that the benefits of the trial data can be realized. In support of this goal, in September 2016, NIH issued the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information to establish our expectation that summary results of NIH-supported clinical trials be submitted to ClinicalTrials.gov for posting within 365 days of the actual primary completion date. This policy is complementary to a 2016 updated HHS regulation aimed at further increasing the availability of information about clinical trials. This policy has already proven to be effective as recent analyses have demonstrated increased clinical trial results information reporting. However, we acknowledge that we still have work to do to increase timely compliance. As such, NIH has implemented multiple strategies, including targeted compliance actions, to get us to our goal. As partners in the clinical trial enterprise, we can fulfill our shared commitment to ensuring clinical trials results information is available to benefit all human health. Most recently, a report from the DHHS Office of the Inspector General (OIG) reviewed NIH-funded clinical trials for which the HHS regulation and NIH policy required the results to be reported in calendar year 2019 or 2020. The OIG found that compliance with Federal reporting requirements could be enhanced by strengthened ...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: blog Open Mike Clinical Trials Clinicaltrials.gov human subjects Source Type: funding