With the recent amendment of FTC guidelines for supplement product claims, many brands are seeking out clinical research to put their formulas to the test. Supplement research can present its own unique challenges, ranging from issues with recruiting enough participants, to figuring out how to tackle the Placebo effect. We will address the most common concerns we hear from supplement brands, and suggest solutions to make your clinical research experience as smooth as possible.
Unlike in traditional pharmaceutical trials, where participants are often motivated by the chance to receive a new treatment for a medical condition, supplement trials typically involve participants in good general health who may not see a clear need for participating.
This is also an area where participants’ fears about the less rigorous regulation of supplements may come into play, as these trials can seem less safe than drug trials to uninformed patients.
We suggest working with a contract research organization (CRO) whenever possible, as these companies will typically help you with patient recruitment and can ensure you meet your enrollment goals and your study stays on track. Recruiting for supplement clinical trials can be aided by other strategies such as social media outreach and automated follow-up campaigns.
Choosing the Right Endpoints
Supplement brands may struggle to identify appropriate endpoints, as these trials can tend to focus on more subjective outcomes (such as improvements in mood, digestion, or energy levels) unlike traditional drug trials which have clear clinical endpoints.
It can be difficult to choose goals that are meaningful for the ultimate goal of creating product claims while also maintaining robust measurability.
Before beginning clinical research, synthesize your goals for your product’s performance. For a supplement aimed at a specific health or wellness concern, ask yourself these questions:
How do I want my formula to improve people’s symptoms? How can I measure this?
For instance, maybe you are creating a supplement designed to improve digestion and you want to use questionnaires to see how many days out of the last week participants experienced bloating or gassiness before and during using your product.
How long will people need to take my supplement before noticing results?
Many supplements take several weeks or even months of use before there are any noticeable changes, so be sure to go into your clinical study with an idea of how long participants will be asked to use your product.
Are there any additional effects people can expect from my formula?
Beyond whatever the main purpose of your supplement is, does your formula boast any additional benefits? Is it calming and good for stress reduction as well as being designed to improve stress? These can become secondary endpoints or additional measures for outcomes you expect from your clinical trial.
The Placebo Effect
The placebo effect is a famous phenomenon wherein people perceive improvements from receiving a treatment, even in the absence of any active ingredients. This is particularly relevant in supplement trials where users may attribute any positive changes in their well-being to starting a new supplement.
The best way to combat the placebo effect is of course to use a placebo group in your study design or use a crossover design where participants will receive both the active supplement and a placebo at separate times. The gold standard of clinical research is a randomized control trial, in which a placebo control is used and neither the participants nor the researchers know which groups participants have been assigned to.
The most commonly reported challenges in supplement clinical trials are patient recruitment issues, identifying appropriate primary endpoints, and navigating the placebo effect. These can all be addressed by first identifying your research goals, and proceeding with study design and participant recruitment from there.
This can best be accomplished with the help of a knowledgeable CRO to guide you on study design, enrollment, intervention processes, and even publishing study results.
Want to create your own clinical trial?
Citruslabs provides a simple and affordable way to prove that your cosmetic products actually work. At Citruslabs, we design a clinical trial that is right for you and your budget, so you can start sharing research-backed product claims without spending a fortune. We offer the cohesive planning and management required to conduct successful clinical trials, from start to finish. Ready to get started? Let's talk! You can contact us here.