Concept: NCCIH Clinical Trials Initiative

Project Concept Review

Council Date: October 2, 2015

Program Director: Wendy Weber, N.D., Ph.D., M.P.H.

Background

The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous evaluation of the clinical effects of complementary and integrative approaches. Program staff have previously presented to Council concepts for the development of initiatives to support clinical research in the areas of mind and body approaches in February 2014, and natural products in October 2014. Both of these presentations discussed the importance of early stage clinical research to inform the design of fully powered efficacy, effectiveness, or pragmatic trials. As a result of the previous concepts, NCCIH issued two funding opportunity announcements to support early-stage clinical research on natural products (RFA-AT-16-001 and RFA-AT-16-002) and mind and body interventions (PAR-AT-14-182). These initiatives are building the evidence base to provide justification for larger scale efficacy or effectiveness trials.

There is a need, therefore, for a mechanism that conveys NCCIH program priorities and special review criteria for later stage efficacy and effectiveness clinical trials research grant proposals.

Purpose of Proposed Initiative

The purpose of this proposed initiative is to encourage efficacy and effectiveness clinical trials of complementary and integrative health interventions in areas that are high priority for NCCIH. An emphasis will be placed on the preliminary data that is needed to justify the design aspects of the trial and demonstrate the feasibility of the intervention in the patient population to be studied. When this preliminary data does not exist, investigators will be encouraged to use other funding opportunities available from NCCIH for early-stage clinical research.

NCCIH would like to utilize a cooperative agreement mechanism for this initiative to allow for NCCIH staff involvement and the more careful follow up and monitoring of these larger scale clinical studies. Using a phased award mechanism will allow for a planning, preparatory period to ensure that all elements of a trial start up are complete before funds are committed to the implementation phase of a clinical trial.