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A. S. PERSAD, Burdock Group, 888 17th St. N.W., Ste. 810, Washington, DC 20006 In an assessment of intervention studies used to support qualified health claim petitions, the FDA not only reviews study findings, but also critically evaluates the design and execution of the study. Sample size, generalizability, sufficient duration to assess adverse health effects, and methods to reduce confounding are some of the key statistical/epidemiological elements evaluated. With the greater reliance on statistics to provide adequate sample size, power, and significance for these intervention studies, the subject of meta-analysis use needs to be revisited. This is especially true in the case where multiple smaller studies have been conducted to show an association between the same test substance and measured outcome, but the individual studies lack the statistical rigor to stand independently. Currently, the FDA has acknowledged reviewing meta-analyses, submitted with the qualified health claim petitions, for gathering background information. However, meta-analysis studies are not included in the body of evidence to support proposed claims due to the lack of detailed information to adequately assess each study within these quantitative reviews. This epidemiological principle behind meta-analyses may hold the key to the proper handling of statistical issues, such as sample size and statistical significance that cannot be attained by independent small studies. As the boundaries of safety and efficacy expand to encompass other scientific disciplines, a better grasp of the tools utilized in epidemiology and biostatistics, and the benefits they can provide, is imperative to a successful qualified health claim petition.
Session 12, Qualified health claims and new regulations: A critical juncture
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |