Sharing clinical trial data is a critical component of maintaining public trust in research and as well as increasing scientific knowledge and improving the translation of research into therapies for patients.
Clinical Trials Registration and Results Reporting
The Department of Health and Human Services (HHS) Sept. 16, 2016, issued the final rule on clinical trials registration and results submission, specifying new requirements and expanding the scope and application of the regulation for the submission of trial data to the ClinicalTrials.gov website. A complementary policy released by the National Institutes of Health (NIH) at the same time requires summary results reporting for all clinical trials funded in whole or part by the NIH, regardless of study phase, type of intervention, or whether they are subject to the Final Rule. More information:
- Latest updates on ClinicalTrials.gov.
- ClinicalTrials.gov support and training materials.
- “Clinical trial registration and reporting: A survey of academic organizations in the United States.” (BMC Medicine, 2018).
NIH Definition of a Clinical Trial and Related Policies
The NIH has enacted a series of policies “to enhance the accountability and transparency of clinical research.” In addition to the policy on registration and results reporting, the agency has established policies for the use of a single Institutional Review Board, Good Clinical Practice training, grant application form changes, and clinical trial-specific funding opportunity announcements.
The studies that are subject to the above policies are determined by the NIH definition of a clinical trial, last revised by the agency in October 2014. The NIH has also released a series of case studies intended to assist investigators in determining whether their human subjects study meets the NIH definition of a clinical trial.
In August 2022, the HHS Office of Inspector General published the results of an audit that found that the NIH had not ensured clinical trial results were reported in accordance with federal requirements. In response, the NIH outlined a series of improvements the agency is implementing to enhance internal procedures and work with responsible parties on registration and results reporting.
NIH key dates and policy notices for clinical trials are summarized by the agency here.
Prospective Basic Science Studies Involving Human Participants
According to the NIH, basic experimental studies involving humans (BESH) are studies that meet both the definition of basic research and the NIH definition of a clinical trial and are therefore subject to NIH clinical trials policies such as registration and results reporting. The agency issued a guide notice for this trial type and created a new category of FOAs specifically for BESH.
FDA Oversight
As summarized by the FDA, the agency oversees compliance for ClinicalTrials.gov and has the authority to take appropriate enforcement action related to failure to submit required clinical trial information to the website. More information:
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“The Importance of Clinical Trial Transparency and FDA Oversight” (Robert Califf, MD, FDA commissioner).
Learn More
The National Clinical Trials Registration and Results Reporting Taskforce is a forum for academic institutions that focuses on clinical trials registration and results reporting requirements. Its objectives are to identify best practices, develop tools for regulatory support and investigators, and serve as a communication forum through monthly calls and other online activities.