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Federal Clinical Trial Policies

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 NIH at the same time requires summary results reporting for all clinical trials funded in whole or part by NIH, regardless of study phase, type of intervention, or whether they are subject to the Final Rule.

AAMC Webinar: The Final HHS Rule and NIH Policy
November 3, 2016, 1:30 –2:30 p.m. ET (Slides) (Recording)

Prospective Basic Science Studies Involving Human Participants

Following language in the 2018 Consolidated Appropriations Act, the NIH is delaying enforcement until Sept. 24, 2019 of registration and results reporting requirements for basic science studies involving human participants. As stated in Notice NOT-OD-18-212,  the agency will provide “additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be transported to ClinicalTrials.gov.” NIH has also instituted a temporary period of leniency for applications submitted to an incorrect FOA based on the study-type designation and plans to issue FOAs specifically for these basic science studies.

The AAMC has submitted comments to the NIH in response to a request for information on registration and results reporting standards for prospective basic science studies involving human participants, including additional data elements needed and strengths and weaknesses of alternative reporting platforms.

NIH Definition of a Clinical Trial and Related Policies

A number of new NIH policies have been enacted in the past year “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 IRB, 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. In August 2017, the NIH 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 collaboration with the Council on Governmental Relations (COGR), Association of American Universities (AAU), and Association of Public and Land-grant Universities (APLU), the AAMC sent a letter to NIH on September 17, 2017, expressing concerns that the case studies broaden the definition of clinical trials to include fundamental and basic health-related research and that the impact on an investigator and research study of designating research as a clinical trial is more significant than has been acknowledged.

Resources

National Clinical Trials Registration and Results Reporting Taskforce

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. To join the taskforce, please visit the membership page on the Taskforce’s website.

Recently published: Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee (2018). Clinical trial registration and reporting: A survey of academic organizations in the United States. BMC Medicine 2018: 16:60

Final HHS rule: Clinical Trials Registration and Results Information Submission

NIH Policy on the Dissemination of NIH-Funded Clinical Trials Information

International Committee of Medical Journal Editors (ICMJE)

For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or (202) 478-9926 or Anu Dev, Lead Specialist for Science Policy, adev@aamc.org

Last updated: November 13, 2018