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NCCIH’s New Approach to Clinical Trials

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April 10, 2017
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

Director
National Center for Complementary and Integrative Health

View Dr. Briggs’ biographical sketch

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.

For More Information

Comments

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I would like to know if a Cuban multidisciplinary team interested in evaluating the therapeutic effects of mesenchymal bone marrow stem cells or the exosomes produced by those in neurodegenerations (early stages) has options in this clinical trial funding opportunity. We could also join a related clinical trial if that was an option. Our center is the International Center for Neurological Restoration (CIREN), in Havana, Cuba. Cordially 

 @ Ivette Fernandez, We appreciate your interest in our new clinical trial funding opportunity announcements. However, NCCIH does not fund this type of research. You may want to reach out to the National Institute of Neurological Disorders and Stroke (NINDS), the NIH institute that focuses on neurological disease. You can contact NINDS at www.ninds.nih.gov/Contact_Us. 

In literature reported and our clinical practice, we found that acupuncture treatment may potetial controling patient’s blood glucose level and  prevent developing complication such as, cardiaovascular problem, kidney failure and eye problem.  Is there any funding mechanisms to support such of clinical trail to collect information and build up protocol for standardlizing for generating therapy of diabetes?

@Lg, NCCIH does accept applications for acupuncture research. An applicant would need to specify clear hypotheses that would be tested and a primary outcome for the larger phase clinical trial. Please draft a short description of the type of trial that you would conduct and e-mail it to nccihderinquiries@nih.gov; we will connect you with a Program Director that can help you determine which funding opportunity can be used to support the trial that you would like to do.

This page last modified September 24, 2017