A comprehensive clinical testing program is essential to the success of virtually all health products. Writing in the International Probiotics Association blog, Josh Baisley, associate director of clinical trials for Nutrasource, notes that ensuring the stability of a probiotic for the duration of clinical studies is a vital aspect of analyzing the outcome.
As the probiotic segment continues to trend upward, more companies are investing in well-designed clinical trials to support efficacy.
One area that has presented substantial learning opportunities, and has helped shape the future of probiotic clinical trials, is the study of antibiotic associated diarrhea (AAD) and probiotic intake.
Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.
Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.
Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.
Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:
Prebiotics and probiotics aren't going anywhere. In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.
Study designs need to support the final claims including marketing claims. Risk management is a key aspect of formulating a robust clinical development program and may include proof of concept studies such as dose ranging or multiple dose studies and pilot studies, prior to engaging in pivotal clinical studies to determine evidence of effect and variability around changes resulting from supplementation with the investigational product.
Clinical research has become a fundamental step in the development of a dietary supplement. Nutraceutical companies are investing more in clinical research than ever before to support health and marketing claims and gain a competitive advantage in a saturated marketplace.
Clinical research in Canada has been declining year over year since 2010. Fluctuations are sometimes seen due to the changing strength of the Canadian versus American dollar as the costs are typically quite similar between countries. Another factor in the recent downturn has been partially credited to Sponsors and contract research organizations (CROs) placing studies in foreign countries or being misinformed that data must be produced in the country they are marketing in. These factors have led to CROs and sites to move to, or open operations in, other countries to adapt.
Bringing a product to the next level can be a challenge. There are many hurdles standing in the way, whether your goal is to support a new claim or re-position your product for a new market.
We've rounded up some of the most common questions we hear from the dietary supplement industry in the hopes that our answers will help you overcome your latest product development challenge.
The verdict is in on one of the two high-profile dietary supplement industry cases before the courts this year. The decision from the U.S. Court of Appeals for the D.C. Circuit upheld the Federal Trade Commission's (FTC) charges that POM Wonderful and POMx ads were deceptive. The ads claimed that the product could treat, prevent or reduce the risk of heart disease and prostate cancer, but lacked clinical evidence to substantiate such claims.
The decision led to questions around how much clinical evidence is required to support a health claim. How is a company promoting the benefits of natural health products supposed to navigate the regulatory landscape when even the guidances are not clear?