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Project Title: Program for Translational Tools for CAM Clinical Research

Council Date: September 12, 2008

Program Officer:
Catherine M. Stoney, Ph.D.
Phone: 301-496-4792
Email: stoneyc@mail.nih.gov

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The overall goal of this initiative is to enhance research on CAM interventions through the development and validation of translational tools that will improve comparability and generalizability of studies. It is expected that such tools will facilitate rigorous study of CAM practices that are in wide use by the public. Specifically, this initiative focuses on encouraging and supporting the development and validation of tools related to the following CAM systems: mind-body medicine interventions, manual therapies, and acupuncture. Subsequent initiatives may address the need for strengthened clinical research tools for herbal therapies, dietary supplements and probiotics.

Background

A large body of research has examined and pointed toward the potential of CAM interventions to promote health and wellness, to treat or prevent disease, and to bring symptom relief and enhancement of quality of life. However, the development of useful evidence bases has often been hampered by the lack of consistent clinical research methodology. There is a critical need for a more systematic approach to measurement of outcomes. Rigorous clinical trials to determine efficacy or effectiveness of CAM interventions also require strengthened methods to ensure consistency, and to assess the adherence to and fidelity of therapy delivery. Improvement in such translational tools for CAM clinical research will potentially increase the quality and consistency of clinical trials in CAM and ultimately elucidate new understanding of the clinical utility and applicability of CAM interventions. It is anticipated that many types of studies may be appropriate for the development and validation of translational tools, including ancillary collections of new data in on-going clinical studies, secondary analyses of existing data sets, and primary validation studies.

Examples of Translational Tools for CAM Clinical Research

Tools to improve conduct and reporting of clinical studies

• Development and validation of standardized, unbiased, and objective measures and instruments to assess dose effects, or describe interventions as administered by practitioners or utilized by study participants;
• Development and validation of standardized protocols for study of CAM interventions or modalities applicable to defined mental and physical health conditions; protocols should include measures to ensure reproducibility, cross-site and cross-study comparability and feasibility of assessment of treatment fidelity;
• Identify tools to assess well-characterized patient populations and contextual factors such as practitioner skill, treatment allegiance, patient-practitioner interactions, and patient experiences for inclusion in subsequent efficacy studies;
• Development of methods to assess treatment adherence;
• Development of methods to assess separation of control and experimental groups;
• Development of methods to assess consistency and fidelity of therapy delivery.

Tools to improve patient-reported outcome measures of CAM clinical investigations

• Development and validation of CAM-relevant Patient-Reported Outcomes Measurement Information System (PROMIS) assessment tools;
• Measurement tools for monitoring adherence to and expectancy for effects of mind-body medicine and manipulative interventions;
• Development of strategies and tools, including biomarkers, for monitoring and identifying safety, potential risks, and adverse effects;
• Characterization of the variability of potential outcome measures in specific patient populations of interest for specific CAM interventions.

Tools to improve biological and physiological outcome measures of CAM clinical investigations

• Identification and development of specific biological measures that may elucidate mechanisms for health benefits of specific CAM interventions;
• Development and validation of biomarkers that correlate with perceived psychological stress, well-being, and wellness;
• Development of data mining, mapping, and associated bioinformatic approaches to data such as brain imaging, to model effects of CAM interventions.