Know your Clinical Research Goals
It is important to understand your research goals before embarking on a clinical trial. Your ultimate aims will determine which kind of study is the best fit for you. Whether you are simply looking to create additional marketing materials which publish user experience or are aiming to back up a new formula with scientifically validated health claims -- your research setup will look different.
Get Expert Input from a CRO
It is okay to begin a clinical trial for your products without knowing the ins and outs of study design -- just be sure to pick a CRO that’s happy to guide you through the details. For instance, here at Citruslabs we often help our research sponsors with every aspect of study design, including the integral literature we use in recruiting patients. We can help craft the clinical protocol and consent forms, as well as any other finite details of study design with as much or as little input from your brand as you feel comfortable with.
Single Group Studies
Single-group studies are a realistic option for most brands aiming to create product claims, as they are simple to set up and require a lower time commitment than more rigorous models. While you are not comparing your product to a placebo or control group in these studies, you are still able to gather validated data on the product’s performance.
This can be accomplished through the use of blood tests, skin grading, or validated questionnaires, depending on the nature of your product, to get the results and data you need. Single-group studies are usually sufficient to create claims in consumer products such as skincare, cosmetics, and supplements.
The Gold Standard - Randomized Control Trials
Often considered the gold standard for clinical research, randomized control trials are a robust clinical study model that provides scientifically valid results. In these models, the basic structure involves researchers working with at least two groups:
One group that received the actual intervention product (i.e. your product)
One group that either receives a placebo or no product at all (the control group)
This general design can then be expanded to include more groups, referred to as study arms. For example, a third arm could use the intervention product at a different frequency than the other active intervention group in order to assess performance and efficacy at different concentrations (importantly operating within the range that has already been proven safe for users.). In a supplement study, one group could take your product once a day while another takes it morning and night.
Double or Single Blinding
Within the randomized control trial structure, you are able to vary the level of blinding in order to change the rigor and validity of your study.
Single blinding is the most common choice, it involves the “binding” of participants such that they are unaware whether they have been given the active intervention or placebo product. This option generally requires a less complex study design and potentially a smaller research team.
Double blinding, on the other hand, means that neither the participants nor the research team knows who has been assigned to which condition.
.Regardless of your specific research goals, a practiced CRO can help guide you toward an appropriate study design. While a Randomized control trial is an ideal choice in terms of scientific validity and rigor, it can be just as beneficial for smaller or new brands to work within their budgets and invest in single-group clinical trials.
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.