Research Funding Priorities
In setting research priorities, NCCIH considers its existing research portfolio, its 5-year strategic plan, the recommendations of the National Advisory Council for Complementary and Integrative Health, current scientific advances, the plans of other NIH institutes and centers, and input from expert panels and stakeholders. Research constituting a rigorous evidence base for complementary health practices will be developed through a range of research strategies including basic and translational research, and clinical investigation.
Current research priorities are shaped by the following considerations regarding Research Approaches, Areas of Special Interest, and Areas of Lower Program Priority.
Basic and Translational Research
NCCIH's support of basic research emphasizes and encourages in vitro and in vivo studies of the biological effects and mechanisms of action underlying complementary health approaches, as well as studies characterizing the active elements of an intervention, Studies should use state-of-the-art techniques in areas such as imaging, pharmacognosy, proteomics and epigenomics, and employ optimal animal models and methodology.
NCCIH's support of translational research addresses the need for valid, reliable, and relevant research tools, outcome measures, and innovative methodology to enhance the rigor or clinical studies of complementary health approaches and to ensure that they are maximally informative. Studies intended to identify and validate objective endpoints or biomarkers, assess and measure adherence or treatment fidelity, and otherwise strengthen the design of subsequent clinical trials of complementary health approaches are emphasized.
Observational Studies and Clinical Investigations
NCCIH's clinical research portfolio utilizes clinical trial, case-control, observational, qualitative, and other experimental methodologies to determine safety and estimate the efficacy of complementary health approaches. The clinical research portfolio also includes studies of the contribution to improved health and wellness made by complementary health interventions as they are practiced in “real-world” settings.
Studies should be designed to inform decision making about the design of and/or the need for subsequent investigations. Important areas of investigation include examination of pharmacology, bioavailability, and ADME (absorption, distribution, metabolism, and excretion) of biologically based interventions; optimizing dosing of all types of complementary health interventions; refinement and validation of outcome measures (including patient-reported outcomes that are particularly relevant to complementary health modalities); optimizing control groups, masking strategies, and other methodological enhancements; obtaining preliminary data on safety and efficacy; and conducting early phase clinical investigations to elucidate mechanisms of action and to test models.
In general phase III clinical trials will be supported under the cooperative agreement mechanism after careful consideration by NCCIH Staff. Investigators interested in proposing phase III studies are strongly encouraged to contact a relevant NCCIH Program Director.
Areas of Special Interest
Although a wide range of research topics are of interest to NCCIH, studies focusing on complementary health interventions used frequently by the American public, and on the conditions for which they are most frequently used are particularly encouraged. These would include, but not be limited to, investigations of the impact of complementary health modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness. Among all types of studies, attention to a range of endpoints meaningful to improved health, well-being, and quality of life is strongly encouraged.
Investigators are urged to discuss applications with a relevant NCCIH Program Director.
Areas of Lower Program Priority
NCCIH is already investing substantial resources in the following areas of research. We will continue to fund novel and significant research on these topics. However, until results of the currently funded studies are available, applications in these areas are likely to be considered of lower program priority. Investigators are strongly urged to contact the relevant NCCIH Program Director before submitting an application in any of the following areas:
- Clinical trials of saw palmetto and African plum (Pygeum) for benign prostatic hypertrophy
- Clinical efficacy or effectiveness studies of low-carbohydrate diets for weight loss
- Clinical studies of silymarin for chronic liver diseases
Note: While the pause on basic science studies of soy has been lifted, please refer to the NIEHS meeting report on batch-to-batch variability in estrogenic activity in commercial animal diets.
Early Stage and New Investigators
NCCIH is strongly committed to assisting new and early stage investigators in establishing a research career. Early stage investigators are those within 10 years of completing their terminal research degree, or their medical residency, or its equivalent. New investigators are those who have yet to compete successfully for a substantial (e.g., R01) NIH research grant. Each Advisory Council round, based on available funds, NCCIH: 1) will consider early stage or new investigator status as one of the criteria for designating grant applications as being of high program priority and 2) may make additional R01 grant awards to new and early stage investigators with percentiles or scores beyond the formal payline.