NCCIH’s New Approach to Clinical Trials
April 10, 2017
As part of an NIH-wide initiative to strengthen the clinical trial research portfolio, NCCIH has released a series of new clinical trial funding opportunity announcements (FOAs) specifically designed for clinical trials focused on 1) natural product studies and 2) mind and body intervention studies.
At NCCIH, we study health interventions widely used by the American public, often with little evidence of efficacy and inadequate understanding of potential safety concerns. One of our goals is to produce high-quality rigorous evidence to support the development of clinical practice guidelines, such as the recently published American College of Physicians’ guidelines on noninvasive treatments for low-back pain. These new FOAs will help us fill in gaps in research and continue to help people manage important health issues, such as nonpharmacologic approaches to pain.
You may be wondering what this means for our research community. As announced in our recent NIH Guide notice (NOT-AT-17-006), we will no longer accept most clinical trial applications through the Parent R01 FOA. Instead, applicants will need to use the new clinical trial FOAs, which will allow them to submit larger amounts of relevant information in their grant applications. These applications will be reviewed by special review panels familiar with NCCIH research priorities, the goals of the FOAs and the particular challenges of studying complementary and integrative health approaches.
NCCIH, however, will continue to accept R01 applications through the Parent R01 FOA that propose a study with human participants when the primary outcome/endpoint is explicitly mechanistic, rather than a clinical outcome, even if the mechanistic study meets the NIH definition of a clinical trial.
Though there is substantial scientific promise in many integrative health interventions, we recognize that the evidence supporting their use is very incomplete. We’re providing pathways via these FOAs to support all developmental steps for relevant clinical trials on complementary and integrative health approaches. Each FOA is targeted for studies at different stages of the research continuum. We will fund early phase trials, intermediate trials, and full-scale efficacy, effectiveness, or pragmatic trials, truly targeting different stages of the research continuum to help establish a stronger evidence base. That includes investment in fostering the “building blocks” that bridge the gap from basic research to high-impact clinical trials, such as feasibility testing, assessment of outcome measures, and intervention fidelity testing.
I encourage you to learn more about these new FOAs on our Web site and register for upcoming NCCIH webinars on April 18, April 24, and May 9.
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