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Clinical Trials Registration and Results Submission


The Department of Health and Human Services (HHS) Sept. 16 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. The rule also states that summary results information must be submitted from a greater number of trials, including those involving Food and Drug Administration (FDA) regulated products that have not yet been approved, licensed, or cleared by the FDA. 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.

Questions or comments on the final rule or NIH policy should be directed to Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at hpierce@aamc.org or 202-478-9926.

NIH Definition of a Clinical Trial and Case Studies

Over the course of 2017-18, a number of new NIH policies will be enacted “to enhance the accountability and transparency of clinical research.” In addition to the policy on registration and results reporting, which took effect January 18, 2017, 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. The agency also released FAQs to clarify the application of the definition, and two blog posts (1,2) by NIH Deputy Director for Extramural Research Mike Lauer, MD. 

The AAMC is concerned that the case studies released by the NIH broaden the definition of clinical trials to include fundamental and basic health-related research; that inconsistencies and insufficient clarity in the analysis may lead to different conclusions from institution to institution about which research will now constitute a clinical trial; and that the impact on an investigator and research study of designating research as a clinical trial is more significant than has been acknowledged. 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 Dr. Lauer on September 17, 2017, expressing these concerns and highlighting several case studies which the organizations do not believe should be designated a clinical trial.

AAMC Webinar on the Final Rule and NIH Policy

A webinar for AAMC institutions was held on Thursday, November 3, providing an overview of the final HHS rule, NIH policy, and the resources and information available to assist with implementation. If you are from an AAMC member institution, you may log in to your AAMC account to access the presentation below:

Clinical Trials Registration and Results Reporting: The Final HHS Rule and NIH Policy
November 3, 2016, 1:30 –2:30 p.m. ET (Slides) (Recording)

Final HHS rule: Clinical Trials Registration and Results Information Submission

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

Clinical Trials Registration Taskforce

The Clinical Trials Registration 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, or determine if your institution is involved, please contact Sarah White, MPH, CIP, Director of the Human Research Quality Improvement Program at Partners HealthCare.

Other Information on Clinical Trial Data Sharing

Institute of Medicine report

International Committee of Medical Journal Editors (ICMJE)

The Yale University Open Data Access (YODA) Project
Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and Harvard

Last updated: September 25, 2017