The vast majority of integrative health products enter the research process at phase 2 clinical trials. Early phase 1 studies, which demonstrate safety, are rarely required for dietary supplements and botanical products. The purpose of phase 1 studies is to demonstrate evidence of safety in human use. This is a necessary step for pharmaceutical drug development, but most natural products benefit from extensive human exposure through traditional use.
Our team creates a custom plan for your phase 2 clinical trial to maximize the potential for demonstrating your product’s efficacy. Our researchers recognize the demands for timeline management, low cost, regulatory requirements, and minimized risk. We mitigate these concerns by integrating our expertise in the natural products field, providing you with productive returns on your investment.
Phase 2 clinical trials are typically conducted to identify evidence of efficacy for your product. These include small-to-medium sized samples, typically in 2-3 arms. At least one arm is a placebo arm and at least one arm is a treatment arm. Our team may design your study to include multiple control arms or multiple treatment arms, depending on your ultimate research goals. Feasibility studies or preliminary data analyses are used to determine the optimal sample size to reduce the risk of false negative results. Studies for this phase typically include 20-80 participants per arm, depending on the population, the product, and the outcome of interest.
Our team emphasizes clinically relevant effects during this process. Many contract research organizations focus exclusively on p-values (statistical significance). While statistical significance is exciting, it fails to provide evidence that the product is capable of producing a meaningful effect. Our team emphasizes effect size throughout the process (from clinical trial development through data analysis) to confirm that your product has a measurable effect on the population within your priority market.
This confirms that your product is capable of delivering on structure/function claims or to progress to phase 3 studies under an IND. It also provides clarity on the effects of your product across varying demographics, providing data that prove invaluable to labeling and marketing efforts.