With the barrier to launching consumer skincare products, supplements, health food, health devices, etc. now significantly lower to almost non-existent, it becomes even more important to showcase WHY your product is the best one. While marketing can help, more and more brands are opting for clinical studies.
The first thing that I often hear when talking to brand owners that are looking into clinical trials is that they want a randomized-control trial. This is usually followed by a shock when I tell them how much a randomized-control trial actually costs - and we’re significantly more cost-efficient than our more traditional counterparts.
When you’re thinking about conducting a clinical trial to prove the efficacy of your product, there is actually more than one way. As with everything, the clinical trial landscape is not just black and white, there are also many shades of grey that should not be overlooked. The biggest question mark that I usually see is the ones around what a clinical trial actually is, and what a consumer perception study is. Many brand owners that are not as familiar with research believe that they are not getting a real clinical trial when they are not conducting a placebo-controlled clinical trial and do not involve instruments or biomarkers. This is wrong. Read on to learn the difference between clinical trials and consumer perception studies.
Clinical trials
Clinical trials can come in many sizes and forms. To bring a new drug to market, companies usually need to run several clinical trials (Phase I-III) to prove the efficacy and also safety, and tolerability of their new drugs. But, what do brands need to do?
For brands, clinical trials are an excellent way to show that your product works. Given that clinical trials will look differently depending on what product you’re selling, we will look at skincare and dietary supplements, and health food separately.
Skincare
Instruments and skin grading
The gold standard for skincare is to involve instruments and skin grading. Through both of these processes, a dermatologist can see differences in, for example, fine lines and wrinkles, skin hydration, hyperpigmentation, skin texture, etc. And an instrument can “prove” that your product actually helps soften fine lines, or helps with hyperpigmentation. Compared to consumer perception studies, the consumer just perceives that their skin feels more hydrated, or that their fine lines got better, or their dark spots got lighter. Clinical trials can happen either through single group studies or through studies with more than one group (sometimes also called “arm”), a so-called randomized-control trial (short: RCT). Here, you either have a placebo-controlled study, with a placebo or a different product (that counts as placebo), or a control group, with no intervention at all. Sometimes it also makes sense to have the same group of participants go through intervention and control group in a so-called crossover clinical trial. This makes sense, for example, in redness studies, showing that your product works quicker in resolving redness after an external irritant is administered. Another possibility for skincare studies is also a split-face study, in which also just one group of participants is used. Here, they will use the intervention (your product) on one side, and the placebo/different product on the other side.
Validated questionnaires
Another possibility for skincare studies are PRO studies. PRO stands for “participant-reported outcome”. Here, validated questionnaires are being used to understand how the product works on the participants. The emphasis here lies on validated questionnaires. A validated questionnaire has been developed (and validated) to assess a specific outcome in a scientific way. While customer perception studies also use questionnaires as an instrument, these questionnaires are not validated and rather fall under the “marketing” category instead of the scientific one. An example of a validated questionnaire to measure skin oiliness can be found here.
Dietary supplements & health foods
For dietary supplements and health foods, it depends on what the supplement/food is targeting. Is it vitamins and/or minerals? Is it skin health? Beauty from within? Sleep? Anxiety? Alleviating PMS symptoms and/or period cramps? Lowering blood pressure? Lowering cholesterol? Lowering hbA1c? Whatever it is, it can be measured either through biomarkers and/or validated questionnaires.
Similar to what we have already discussed, there are different designs that can be followed, such as a single group study, or an RCT (randomized control study), with a placebo and/or control group. A crossover study is also possible.
Biomarkers
The most obvious way to show efficacy in dietary supplements and health food is through bloodwork. Think of the claim you want to make, for example, increase in certain vitamins or decrease in cholesterol - this is exactly what blood tests can help you with. You can amplify those claims with additional validated questionnaires to show, for example, also an increase in energy, an increase in overall wellbeing or quality of life, or a decrease in pain, after taking the specific supplement.
Blood biomarkers can also be enhanced through digital biomarkers, such as blood pressure measurements, weight, duration and quality of sleep, etc.
Validated questionnaires
Not every brand has the budget to sponsor a clinical trial that involves biomarkers. Here, validated questionnaires can provide a great alternative. You can use validated questionnaires for pain, energy levels, sleep quality, quality of life, overall wellbeing, anxiety, stress, etc., etc., etc. Whatever your product is tackling, there is probably a validated questionnaire you can use.
All clinical trials take a scientific measurement into consideration, regardless if they use instruments, biomarkers, or “only” validated questionnaires. As such, all clinical trials have to go through IRB (short for institutional review board). The IRB is an ethics committee that is reviewing the methods of a study to ensure that they are ethical. Additionally, clinical trials are usually conducted by an independent third party on behalf of the sponsor.
Consumer perception studies
Consumer perception studies usually use only questionnaires as a measurement. These questionnaires are not validated and therefore are not scientific. Most consumer perception studies will ask a range of questions and ask the consumers if they agree or disagree with a range of statements.
Consumer perception studies are rather a marketing instrument. These types of studies don’t require IRB approval and are not scientific. Brands can also conduct these studies in-house and don’t need an independent third party.
To summarize, here are the main differences between clinical trials are consumer perception studies:
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We bring together everything that's required to plan, conduct and manage successful clinical trials from start to finish. Ready to get started? Let's talk! You can contact us here.
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