Final Rule for Mandatory Reporting of Clinical Trials Results on Clinicaltrials.gov: No Excuses

Last week, NIH released the final rule for registering clinical trials and reporting results for completed studies. The most important part of the final rule is regarding the submission of results from completed clinical trials. Starting 18 Jan 2017, all completed clinical trials will be required to submit results on clinicaltrials.gov within 1-3 years of study completion or face stiff monetary penalties. It is well known that while the listing of clinical trials on the clinicaltrials.gov registry is very robust, the submission of results on that same website is not. Only about 10% of clinical trials listed on clinicaltrials.gov include results even several years after completion of the trial. If we take out the non-interventional and Phase 1 studies, the number of studies with results is only slightly better at 15-18%. The final rules plans to change that. Going forward, all Phase 2 and above clinical trials with FDA approved or not-approved products (drug, biologics and medical devices), must report results on clinicaltrials.gov within 1 year of the completion of data collection in support of the primary endpoints. Primary completion date for a clinical trial is the date that the final subject was examined or received an intervention for the purpose of collecting the data for the primary outcome measure. Sponsors are expected to submit all the data for a given trial but in case the secondary outcomes are still being evaluated, partial results only for the primary outcome must be submitted. Further, sponsors are required to submit full clinical protocols and statistical analysis plans as separate standalone documents to their clinicaltrials.gov postings. This applies to absolutely all applicable trials, no exceptions. Even studies that are terminated for any reason must have available results posted. The rule goes into details of what results to post, and the kind of data to be included. The rule is extremely detailed; the 710 page document discusses practically all aspects of clinicaltrials.gov posting and addresses practically all comments presented by 900 commentators. Sponsors of clinical trials have no excuses to not post results of their clinical trials. The clinicaltrials.gov will finally be the encyclopedia of clinical trials information it was designed to be.