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Introduction
The National Center for Complementary and Alternative Medicine (NCCAM) regularly examines and redefines its research priorities in order to fill gaps in its portfolio and capitalize on emerging opportunities to advance complementary and alternative medicine (CAM) research and to leverage the expertise and resources of other NIH Institutes and Centers (ICs) and agencies. This prioritization evolves through a formal semi-annual planning process that draws on an analysis of the existing grants portfolio, the expertise of NCCAM's extramural program staff, extensive interactions with staff of the other NIH ICs, as well as the recommendations of the members of the National Advisory Council on Complementary and Alternative Medicine (NACCAM), expert panels, and numerous other stakeholders.
As with other components of NCCAM's portfolio, the substantial financial and intellectual commitments that are being made to the Centers for Research on Complementary and Alternative Medicine (CRC) Program, and to each individual center, dictate that funding of meritorious applications to this program be guided by consideration of ever-evolving program priorities. A list of NCCAM's current priorities relevant to the CRC Program follows. This list will be updated yearly on or about October 1. The principles that will further guide NCCAM's decisionmaking are described below.
In 2003, NCCAM awarded Developmental Centers for Research on CAM focusing on the mechanisms and effects of chiropractic manipulation, and on Oriental medical systems, particularly acupuncture for ovarian cancer and endometriosis. NCCAM has also funded two Centers of Excellence for Research on CAM, one focusing on the neurobiological basis of acupuncture and acupuncture analgesia using neuroimaging techniques, and a second on the effects of antioxidant therapies. Proposals for Centers substantially similar to those already funded may be given lower program priority.
The principles that will further guide NCCAM's decision making are described below.
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A Priority To Elucidate Mechanisms of Action and Conduct Small, Well-Developed Phase I and II Trials
Examination of NCCAM's existing research portfolio reveals heavy investments in clinical trials. Expert panels convened by NCCAM and members of the National Advisory Council concluded in 2002 that the research portfolio would be better served by an increased emphasis on studies of the mechanisms underlying CAM approaches, and by more thorough examination of the interventions themselves, as critical preparation for, and to better ensure the success of, more substantive phase II and III trials.
Elucidating the underlying mechanisms of action of CAM therapies will further facilitate the acceptance into mainstream medicine of CAM therapies that are proven safe and effective. Mechanistic studies of CAM therapies will improve the identification of key study endpoints and thus strengthen the design of clinical trials. Moreover, they will contribute to the overall biomedical knowledge base and encourage more experienced scientists to invest in CAM research.
Lack of adequately defined products or optimal dosage schedules risks that premature efficacy studies might fail, casting a pall over further research into otherwise promising modalities. Therefore, studies to determine active ingredients, dosing, pharmacology, stability, and bioavailability; to identify surrogate markers; and to assess study feasibility are priorities for the CRC program. The outcomes of these studies will form the basis for larger trials with an enhanced ability to detect a meaningful positive effect, if any, of the therapy under study. The CRC program will not include substantive phase II and phase III clinical trials.
Among the core components of the CRC, the Centers of Excellence for Research on CAM (CERC) are required to emphasize studies of the mechanisms of action of CAM therapies. There is no absolute requirement for studies of basic mechanisms in the Developmental Centers for Research on CAM (DCRC). However, DCRC applicants that do propose preclinical studies will receive special consideration.
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A Priority To Build Infrastructure in CAM Institutions
NCCAM recognizes that CAM institutions are still evolving their capacity to conduct research. Nonetheless, their unique clinical expertise and cultural perspectives dictate that special consideration be given to meritorious applications from CAM institutions.
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A Priority To Collaborate
Collaboration is a guiding principle that NCCAM has pursued since its inception in 1999. NCCAM considers collaborations between conventional and CAM institutions to be an attractive aspect of competitive applications for centers funding. Such collaboration is required of DCRC applications and would be a welcome aspect of applications for CERCs.
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FY 2004 Research Priorities
NCCAM's list of priorities remains unchanged from FY 2003.
Arthritis--Preclinical and early phase clinical investigations of CAM approaches (other than acupuncture) to chronic arthropathies; studies of the mechanisms and pharmacology of glucosamine and chondroitin sulfate
Asthma/allergy--Basic and clinical investigations of CAM approaches to treatment and prevention of asthma and allergy
Cardiovascular diseases--Preclinical and early phase studies of approaches to manage hypertension, heart failure, stroke, and peripheral vascular disease, including studies of the biology of EDTA chelation therapy in animal models
Climacteric--Preclinical and clinical studies of the endocrinological and symptomatic effects of popular CAM approaches to menopause and 'andropause'
Digestive diseases--Preclinical and clinical investigations of chronic hepatitis, inflammatory bowel disease, and irritable bowel syndrome
Immunology--Preclinical and clinical studies of CAM approaches that purport to enhance or inhibit immune responses
Infectious diseases--Preclinical and clinical studies of antimicrobial and palliative effects of CAM therapies on infectious diseases, especially HIV/AIDS
Manual therapies--Clinical applications and investigations of the biomechanics and neurobiology of manual therapies
Mental health--CAM treatment of affective and anxiety disorders and studies of mechanisms
Mind-body medicine--Neurobiological, neuroendocrinological, and neuroimmunological mechanisms; brain imaging and clinical applications of CAM approaches such as meditation and hypnosis
Neurological diseases--Multiple sclerosis and neurodegenerative disorders using in vitro studies, animal models, and small targeted studies in affected populations
Pain--Preclinical neurobiological studies of the mechanisms underlying CAM approaches to the management of acute or chronic pain
Probiotics--Preclinical and clinical studies of the use of probiotics to prevent or treat infectious diseases
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