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Research and Training in Complementary and Alternative Medicine - #93.213

To evaluate alternative, complementary, or unconventional medical treatments. The following objectives support this goal: (1) coordinate and facilitate the investigation of alternative medical practices through peer-reviewed grant solicitations; (2) interface with the Center's National Advisory Council; (3) conduct technology assessment conferences for the purpose of establishing areas of Clinical and Pre-clinical research that need to be further developed within Alternative Medicine; (4) maintain a comprehensive bibliographic data base in conjunction with the National Library of Medicine; (5) and (6) establish an intra- and extra-mural clinical research fellowship program focusing on broad areas of clinical, scientific, and administrative training in CAM. The National Center for Complementary and Alternative Medicine (NCCAM) regularly examines and redefines its research priorities. In setting research priorities, NCCAM considers its existing research portfolio, its 5-year strategic plan, the recommendations of the National Advisory Council for Complementary and Alternative Medicine, 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 CAM 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. Research Approaches Basic and Translational Research NCCAM's support of basic research emphasizes and encourages in vitro and in vivo studies of the biological effects and mechanisms of action underlying complementary and alternative medicine (CAM) 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. NCCAM'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 CAM clinical studies 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 CAM clinical trials are emphasized. Observational Studies and Clinical Investigations NCCAM's clinical research portfolio utilizes clinical trial, case-control, observational, qualitative, and other experimental methodologies to determine safety and estimate the efficacy of CAM approaches. The clinical research portfolio also includes studies of the contribution to improved health and wellness made by CAM 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 CAM interventions; refinement and validation of outcome measures (including patient-reported outcomes that are particularly relevant to CAM 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 NCCAM Staff. Investigators interested in proposing phase III studies are strongly encouraged to contact a relevant NCCAM Program Officer. Areas of Special Interest Although a wide range of research topics are of interest to NCCAM, studies focusing on CAM 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 CAM 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 NCCAM Program Officer. Areas of Lower Program Priority NCCAM 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 NCCAM Program Officer 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 Clinical studies using probiotics Early Stage and New Investigators NCCAM 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, NCCAM: 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. NCCAM continues to accept applications in areas not listed. All investigators are urged to discuss potential applications with the relevant NCCAM Program Officer.

(Project Grants) FY 09 $88,547,000; FY 10 $91,361,000; FY 11 $93,040,000

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