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WHY, WHEN, WHAT, AND HOW OF CLINICAL TRIALS: EDUCATIONAL SESSIONS

NOVEMBER 9, 2005, LAS VEGAS, NEVADA
SUPPLYSIDE WEST INTERNATIONAL TRADE SHOW AND CONFERENCE

With growing recognition of the importance of conducting clinical trials to evaluate the safety and efficacy of dietary supplements, the Office of Dietary Supplements (ODS) was invited to organize three educational sessions at the November 2005 SupplySide West International Trade Show and Conference. The sessions featured scientists from academic and government who spoke on the value of conducting clinical trials, designing trials to test hypotheses, appropriate selection of test materials and study subjects, and interpreting study findings, and funding clinical trials.

Session I: Important Factors for Designing Clinical Trials

This session delved into factors to consider when designing clinical trials. The importance of conducting clinical trials is unquestioned. However, these trials should be properly designed if they are to be an effective test of the hypothesis.

Moderator: Leila G. Saldanha, PhD, RD, Scientific Consultant, ODS, NIH
    The importance of conducting clinical trials? (PDF, 539kB)
    Floyd (Ski) Chilton, PhD, Professor Physiology/Pharmacology and Director of The Wake Forest & Brigham and Women's Center for Botanical Lipids

    Designing trials to test your hypothesis (PDF, 202kB)
    Mary L. Hardy, MD, Associate Director, Center for Research in Dietary Supplements and Botanicals at the University of California, Los Angeles (UCLA) and Medical Director of the Cedars-Sinai Medical Center Integrative Medicine Program.

Session II: Selecting Clinical Trial Test Materials and Study Subjects

This session provided comprehensive information on these important components that can affect the results and conclusions that can be drawn from a study. Among the key factors to consider when designing and conducting clinical trials are the appropriate selection and evaluation of test materials, study subjects, and biomarkers.

Moderator: Joseph M. Betz, PhD, Director, Dietary Supplements Methods and Reference Materials Program, ODS, NIH

Session III: Interpreting Study Findings

This session provided an overview of what the National Center for Complementary and Alternative Medicine (NCCAM) expects of investigators who conduct NCCAM-funded clinical trials. It also provided a perspective on evaluating the scientific evidence required to support health claims from the Food and Drug Administration (FDA).

Moderator: Joseph M. Betz, PhD
    NCCAM approach to study design (PDF, 812kB)
    Jonathan D Berman, MD, PhD, Director of the Office of Clinical and Regulatory Affairs, National Center for Complementary and Alternative Medicine (NCCAM), NIH

    FDA/CFSAN perspectives on scientific requirements to support health claims: Evaluating the strength of the relationship (Presentation not available)
    Paula Trumbo, PhD, Center for Food Science and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)