Revised May 2017
In October 2016, NIH launched a multifaceted effort to improve the quality and efficiency of clinical trials, an effort that is focused on a variety of key points along the “lifespan” of a clinical trial. “These initiatives will reengineer the process by which clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees the progress of the research and how results and aggregate data are shared broadly and rapidly. Specifically, these changes are aimed at enhancing the application and award processes, increasing NIH’s ability to assess the merits and feasibility of clinical trial applications; improving oversight and transparency; and increasing the sharing of clinical trial results. In combination, these initiatives are intended to ensure rigor and efficiency in the US clinical trial enterprise.” (JAMA. 2016; 316(13):1353-1354).
- NIH Definition of Clinical Trial (Updated 2014): A clinical trial is 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 health-related biomedical or behavioral outcomes. For more information, please refer to the Notice of Revised NIH Definition of “Clinical Trial” or NIH Office of Science Policy.
NIH Policy establishes Good Clinical Practice (GCP) Training (Effective January 1, 2107) expectation that all NIH-funded investigators and clinical trial staff who are involved in the conduct, oversight, or management of clinical trials as well as NIH staff who design, oversee, manage or conduct clinical trials be trained in GCP, consistent with principles of the International Conference on Harmonisation (ICH) E6.
- NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
- NIDA Standard Operating Procedure on Good Clinical Practice Training for NIDA Staff and Staff Supported by NIDA-Funded Research and Involved in the Design, Conduct, Oversight, or Management of Clinical Trials (PDF, 198KB).
New HHS rule and NIH policy (Effective January 18, 2017) specifying requirements for clinical trial registration and summary results information reporting affects all NIH-funded clinical trials. Under the NIH Policy, all clinical trials funded in whole or in part by NIH, regardless of study phase or type of intervention will be expected to register at ClinicalTrials.gov and report findings. Read the summary.
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- NIDA Standard Operating Procedure on Clinical Trial Registration and Reporting for NIDA Funded Clinical Trials (PDF, 164KB)
- What NIH Grantees Need to Know About FDAAA
- Registering with ClinicalTrials.gov
Starting with application receipt dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. This means that, after this date, applications planning a clinical trial that are submitted to a non-clinical trial FOA will be returned without review.