NIH Policy on Dissemination of NIH- Funded Clinical Trial Information

Transcription

1 NIH Policy on Dissemination of NIH- Funded Clinical Trial Information Valery Gordon, Ph.D., M.P.H. Senior Advisor for Human Subjects Protection Division of Clinical Innovation 2018 Spring CTSA Program Meeting

2 Publication of Clinical Trial Results Less than 50% of NIHfunded clinical trials are published within 30 months of completion Source: BMJ 2012;344:d

3 Public Benefits of Clinical Trial Information Sharing Inform future research and research funding decisions Mitigate bias (e.g., non publication of results, especially negative results) Prevent duplication of unsafe trials Meet ethical obligation to human subjects (i.e., that results inform science) Increase access to data about marketed products All contribute to public trust in clinical research 3

4 Goals of NIH Policy on the Dissemination of NIH- Funded Clinical Trial Information To promote broad and responsible dissemination of information on NIH-funded clinical trials using ClinicalTrials.gov Consistent with longstanding premise that results of NIH-funded research must be disseminated to contribute to the general body of scientific knowledge and, ultimately, to the public health. NIH awardees have always been expected to make the results of their activities available to the research community and to the public at large because it is intrinsic to the scientific process. Complementary to statutory mandate under FDAAA, Title VIII, which requires registration and submission of summary results of clinical trials regulated by FDA 4

5 NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information Draft NIH Policy on Dissemination of NIH-funded Clinical Trial Information published for comment in the NIH Guide for Grants and Contracts on November 19, 2014 Final Policy published in NIH Guide September 6, 2016 Effective date: January 18,

6 NIH Policy applies to NIH-Funded Clinical Trials NIH definition of clinical trial A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on healthrelated biomedical or behavioral outcomes. Questions? 6

7 Provisions of NIH Policy Registration and results submission to ClinicalTrials.gov of all NIH-funded clinical trials, regardless of Size Phase Type of intervention Same timelines as regulation that implements Title VIII of FDAAA Registration not later than 21 days after first enrollment Submission of results one year after the primary completion date Compliance is a term & condition of award 7

8 Information for Applicants Applications should include Dissemination Plan Part of FORMS-E package (see: NOT-OD ) Dissemination Plan content Ensure that clinical trials will be registered in, and that results information will be submitted to ClinicalTrials.gov as specified by the NIH policy Assure that informed consent documents will include a specific statement regarding posting of clinical trial information to ClinicalTrials.gov Document that applicant has internal policy for clinical trials registration and results reporting, which is consistent with NIH policy. Awards Notice of Award may not be issued until the Dissemination Plan has been accepted by NCATS. 8

9 FORMS-E 9

10 Key Definitions Enrollment Date Date that a human subject or their legally authorized representative agree to participate in a clinical trial following completion of the informed consent process Primary Completion Date Date the final research participant was examined or received an intervention for the purposes of final collection of data for the primary outcome For studies with multiple primary outcome measures, the date that data collection was completed for all of the primary outcomes When the estimated completion date was updated to the actual primary completion date 42 CFR 11.10(a) and (b)(17) 10

11 Why comply with the policy? Term & Condition of award Required by most medical journals (ICMJE) Registration for all clinical trials (all interventions) Center for Medicare and Medicaid Services (CMS) requires NCT Number for coverage of routine costs of qualifying clinical trials U.S. Department of Veterans Affairs (VA) requires registration and results reporting of VA-funded clinical trials National Cancer Institute (NCI) requires results reporting in a peer-reviewed scientific journal or ClinicalTrials.gov 11

12 Connect With NCATS: ncats.nih.gov/connect Website: ncats.nih.gov Facebook: facebook.com/ncats.nih.gov Twitter: twitter.com/ncats_nih_gov YouTube: youtube.com/user/ncatsmedia E-Newsletter: Announce Listserv: 12