Recently the U.S. Department of Health and Human Services published their Final Rule on Clinical Trials Registration and Results Information Submission (Section 801 of the Food and Drug Administration Amendments Act, more commonly referred to as FDAAA 801) which was effective January 18, 2017.
This new final rule requires all clinical trial results must be published on ClinicalTrials.gov within 12 months of the trial completion date.
A current high-level analysis of the database as of January 2017 shows that only 19.6% of trials currently listed in ClinicalTrials.gov submitted their results. This percentage is only for the types of trials that fall within the reporting requirements defined by Section 801 (e.g. One year past study completion, interventional design, phase 2 or greater, etc.)
Improving the data within ClinicalTrials.gov can allow for better future research endeavors, reduce duplicate studies, and help healthcare providers to make better medical decisions. Failing to submit results within the designated time frame can have serious consequences. According to the Final Rule, the responsible party can face penalties including monetary fines and the withholding of grant funds.
The websites below include several worksheets to aid industry sponsors, NIH, academia, etc. in knowing what elements need to be reported and in what format to report them. This can be a complex process with a great deal of tracking study progress and final results prior to submitting results in the necessary format to ClinicalTrials.gov
ACI Clinical can help ensure that all of your trial data is organized and submitted correctly within a timely manner. Whether it’s a onetime project, or multiple sets of trial data, you can ensure that we will meet all requirements and expectations for submission.
To learn more about our services, please contact us.