Making a Claim: Regulatory Considerations

Clinical trials are an insurance policy for claims purposes. Designing good randomized clinical trials that can prove efficacy for dietary supplements is challenging. For clinicians to be convinced of the value of Dietary Supplements, they need the proof of their safety and efficacy. Study designs should be tailored to answer specific questions about whether the intended claim is broad or specific.

What You Will Learn:

• Research Requirements for Claims Substantiation in North America
• Key elements of Study Design
• Subgroup Analysis
• Statistical Significance vs. Clinical Relevance
• Current changes in regulations to support paradigm changes to support subgroups.