Get the evidence you need to demonstrate efficacy
The overwhelming majority of natural health products enter the research process at Phase 2. Why? The goal of Phase 1 research is to evaluate whether or not a product is safe enough to use for larger studies. Because natural products typically consist of ingredients with a lengthy history of use in human health, preliminary safety data already exists. As a result, natural products begin the research process with a focus on efficacy.
Phase 2 clinical trials evaluate the effects of a product on its target population. They tell us whether or not products work at their intended purpose. These studies range from a few dozen to a few hundred participants and can include multiple treatment groups. They also monitor for safety and provide evidence for biological activity (i.e. proof of concept), optimal dosing (i.e. dose-finding studies), and related endpoints.
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.
About Phase 2 Studies
Efficacy Confirmation: The most common benefit of a Phase 2 trial is that it allows you to substantiate your product's efficacy. This unlocks new structure / function claims, OTC drug claims, and can even help you progress to Phase 3 trials if your product is following the new drug development pathway under an IND.
Formulation Superiority: Phase 2 trials also allow you to compare different formulations so you can identify the most powerful version of your product.
Dose-ranging and Dose-response Testing: Application and dosing in the natural products industry vary dramatically. Phase 2 trials provide critical data regarding the effects of differing doses (i.e. Should the dose be increased? Should it be administered more frequently?), identifying the most effective exposure to your product.
Effect Size: When choosing between effective treatment options, clinicians often prioritize larger effects. Our team evaluates total size of your product's effects, allowing you to demonstrate that your product's effects are clinically meaningful, not merely statistically significant.
- Sample Size: Small to Medium (20-100 participants per group)
- Groups: At least one treatment and one control, standard of care, or placebo (formulation superiority and dose-response trials may have 3+ groups)
- Outcomes: Multiple primary and secondary endpoints for evaluation
- Misc: Randomized and Blinded
Our team will calculate the optimal size for your trial based on a power analysis of relevant data or pilot studies. This protects your study from both the risk of false negative results and the high costs of excess study participants.
The specific size and number of groups is determined by the target population, the product, and the outcome(s) of interest.
Are Phase 2 trials right for your needs?
Schedule a FREE 30 minute consultation and receive a no-obligation estimate for your project.