Sponsors face a great deal of pressure for clinical trial success due to timelines, cost, low predictability, and regulatory requirements. At Nutrasource, we leverage our knowledge of nutrition, nutraceuticals, and pharmaceuticals to help our clients manage trials efficiently and effectively to support a successful market launch.
Understanding your unique product goals and the claims you wish to make—both scientific and marketing—allows our team to tailor your Phase II clinical trial (and, where applicable, Phase III trial) appropriately to maximize the potential for demonstrating efficacy. We look at each study objectively to provide you with the clinical trial design, site location(s), and team members that will fit best with your clinical research needs and goals.
Phase II Studies
Nutraceutical Sponsors may begin development with a Phase II clinical trial, bypassing early clinical development/Phase I studies when supporting safety evidence in humans already exists. This differs from the traditional pharmaceutical drug development model.
Dose-ranging and dose response studies are key in the development of pharmaceuticals but also have a place in your nutraceutical clinical development program. Valid dose response data allows appropriate dosing and maximum recommended dose to be determined. Dose response studies can elucidate appropriate timing of dose (morning versus evening) and frequency of dosing, maximizing the efficacy of your product.
Phase II clinical trials are often positioned as proof-of-concept (pilot) studies with the primary purpose to explore whether 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 clinical trials as an opportunity to manage risk. Depending on clinical trial design, conclusions can still be made about a product’s efficacy, and the research will form the basis of claim substantiation files. Phase II studies provide Sponsors with information to make informed decisions regarding dose, effect size, 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, often multi-centre trials that confirm the effects shown in Phase II clinical trials. The need for Phase III trials depends on the findings of earlier stage trials as well as the necessity (as per regulatory specifications) to support health and marketing claims. For example, in Canada, at least one Phase III study is needed to support a disease prevention claim for natural health products (NHPs).
Phase III clinical trials often present their own challenges, especially speed of recruitment. Feasibility studies, and Phase II study data, are key to mitigating risk when undertaking Phase III pivotal trials.
Nutrasource’s unique approach is built on:
- Expertise from both pharmaceutical and nutraceutical development, including dietary supplement to drug strategy
- Understanding of regulations in major markets including, but not limited to, Canada, the U.S., and the EU
- North American site network with access to over 50 Canadian sites and 200 U.S. sites
- Full vertically-integrated service platform of interdisciplinary offerings
These core capabilities enable us to:
- Conduct feasibility studies/assessments to efficiently recruit patients
- Carry out appropriate site selection to achieve your clinical goals
- Streamline clinical monitoring for better trial performance and success
Learn how we can help you manage your Phase II or III clinical trial for the greatest chance for success.