Clinical trials are a vital part of the marketing messages supplement companies use to connect with and educate consumers, but regulations and study design are factors to be considered before marketing or research begins. As marketing goals increasingly demand the use of health benefit claims and regulatory agencies increasingly take action against violative claims, it is important for marketing goals and personnel to be involved in the process of clinical study design.
Factoring marketing into the study design can help ensure the study results would address the needs of both the company and its customers.
Some market segments, such as immune or inflammation products, face higher levels of scrutiny from regulators, so it is especially important to consider and balance what the market demands relative to claims, and what the law will allow. The basic limitation is dietary supplements cannot be marketed to treat, prevent or cure disease. Aspects of a clinical study on supplements or dietary ingredients can cause marketing of the study to enter into disease claim territory and draw the ire of regulatorsand guidelines can differ between countries.
Clinical studies that specify or imply a disease endpoint can be used as substantiation for legal claims (e.g., structure/function claims) at the request of FDA or a similar regulatory body, but they cannot be used in marketing a supplement. Likewise, it may be best for supplement marketers to avoid using clinical trials that involved a disease population, even if the featured endpoint does not express or imply a benefit to disease. There are gray areas, especially in segments such as inflammation where FDA has said maintenance claims must qualify an effect only on inflammation from normal activities such as exercise. However, operating in these gray areas can get out of control and trigger warnings and other action from regulators.
The INSIDER Digital Pulse on Marketing Clinical Trials looks at how marketing can be involved in the design phase of clinical trials on dietary supplements and ingredients, and reviews some regulatory considerations to make sure the results of such trials will be usable in marketing and provide the value the study sponsor seeks. It will also outline the different types of research available and touch on the value of the randomized controlled trial (RCT) model for supplements and nutrients.