Phase II and Phase III Clinical Trials
There is increased pressure for success in clinical studies due to timelines, costs, low predictability and regulatory requirements. At Nutrasource, we combine clinical expertise in the areas of nutrition, nutraceuticals and pharmaceuticals, as appropriate, to manage trials efficiently and effectively to support product investigations in support of a successful product launch.
Understanding your development plan and the claims you wish to make, both scientific and marketing, for your unique product allows Nutrasource to tailor your Phase II (and where applicable, Phase III) program appropriately to maximize the potential for your product to succeed in demonstrating efficacy. We look at each study objectively and provide you with the trial design, site location(s), and team that will most effectively work toward achieving your clinical goals.
Phase II Studies
Differing from the traditional pharmaceutical drug development model, nutraceutical sponsors may begin development with a Phase II study, bypassing Phase I studies as evidence may be publicly available that pertains to the finished product’s safety through toxicological studies and/or published human studies on the ingredients contained in the finished product.
Dose-ranging and dose-response studies are key studies in the development of pharmaceuticals and have a place in your nutraceutical clinical development program. Valid dose-response data allows for the determination of appropriate dosing and maximum recommended dose, while dose-response studies can elucidate appropriate timing of dose (morning versus evening) and frequency of dosing, maximizing the efficacy of your product. A professional product development plan will identify the need for a dose-ranging study or the ability to determine dose from existing data.
Phase II studies are often positioned as proof of concept (pilot) studies with the primary purpose to explore if the product has clinical efficacy. Too often, emphasis is placed on these studies to be pivotal studies providing statistical significance in a small number of subjects without understanding the characteristics of the study population, optimal dose, placebo response and/or effect size of the product. Instead, we encourage our clients to think of phase II studies as an opportunity to manage risk.
Depending on design, conclusions can still be made on a product’s efficacy and the study(ies) that form the basis of claim substantiation files. Phase II studies provide Sponsors with the information to make informed decisions regarding dose, effect size (or how well a product works), population of study and appropriate endpoint(s) to provide the best chance for success, and statistical significance, in subsequent pivotal trials.
Phase III Studies
Phase III studies are larger and often multi-centre trials that confirm effects demonstrated in Phase II clinical trials. The need for Phase III trial designs is dependent on the findings of earlier stage trials as well as the necessity, dependent on the regulatory requirements, for the claims on the product. For example, in Canada, at least one Phase III study is required to support a disease prevention claim for supplements.
Phase III studies often present their own challenges, especially with respect to speed of recruitment. Feasibility studies and phase II study data are key requirements to mitigate risk when undertaking phase III pivotal trials.
Looking for more information on Phase II and III clinical trials? Contact a member of our team today or email us directly at email@example.com. You may also request a customized quote and we will contact you with details within two business days.