The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials. It is not intended to expand the scope of the category of clinical trials. No changes have been made to the NIH definition of a “Phase III clinical trial.”
In addition, because clinical trials are subject to additional oversight, a clearer definition will help investigators ensure that they are meeting all of their obligations, and it will help NIH ensure that the additional oversight is occurring when it is needed. For example, NIH policy requires clinical trials to be monitored, and applicants and offerors seeking NIH support are expected to describe their plans for data and safety monitoring in their applications and proposals. Final data and safety monitoring plans must be approved by the NIH prior to award. In addition, throughout the life of the award, NIH staff monitors the clinical trial’s progress to ensure that milestones are met and that any safety concerns are addressed.
The revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.
More information and training
Clinical Trial Requirements for Grants and Contracts
NIH Definition of Clinical Trial Case Studies
Training Resources for the new NIH Clinical Trial Policies