If you’re looking into a clinical trial to lend legitimacy to your products and brand, you might think that research methods used by the bulk of pharmaceutical companies are your only options. In reality, a double-blinded placebo-controlled experiment (sometimes also referred as randomized control trial, or RCT), while effective, is not usually the best choice for brands -- especially if you’re in the business of dietary supplement creation or skincare products. In short, these randomized control studies that are double-blinded and placebo controlled are expensive, take a long time and usually are not necessary for your brand, specifically if your goal is to create research-backed claims for your products. In this article, we discuss randomized control trials, and also single group studies, so that you can make an informed decision on your study design and don’t have to just blindly trust your research team or CRO.
Let’s look into randomized-control studies:
Here, researchers work 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)
You can also extend this study type and have 3 or 4 different study groups (often referred to as “study arms” as well).
For randomized-control studies, you have different options:
Double Blinded Clinical Trials:
You have likely heard of a double-blind trial -- but what does this actually mean? Essentially, blinding is the process by which researchers hide placebo group assignments. In the case of double-blinding, neither the researchers nor the participants will know what group each participant is assigned to (it will be randomized instead by a third party.) This is done to reduce bias and ensure accurate results.
While the double-blind is often denoted the “Gold Standard” or research, it is not necessary for most non-medically essential clinical trials. In these cases, we would often use Single-blinding. Here, as your CRO we will know the group assignments, but the participants will not.
Other study options:
Another popular option for clinical research of this type is the cross-over study. Cross over studies work by exposing two groups of participants to the same treatments, but in different sequences. For instance, an AB/BA model might work by having group 1 take supplement A for a month, and then supplement B for another month. Group 2 will do supplement B first, and then supplement A.
These can be a more cost-effective study option, as they allow for a smaller overall participant pool than a traditional single or double blind study might require.
Single group studies:
One form of study design that is often overlooked are those known as single-group studies. Here, your clinical trial will only have one group. This group is the intervention group. While you are not comparing your product to a control group (i.e. a pure control with no product or a placebo group), you can still measure if your product works. For example, you can use blood tests, skin grading, or validated questionnaires (whatever fits the needs of your clinical trial) to get to the results and data you need. Especially if the goal of your study is to create claims, single-group studies are usually sufficient.
Which study is right for my brand?
In order to decide on a study design, it’s best to discuss all of your options with your research team. Your research team can either be in-house, or outsourced. You should talk to different CROs to see which ones fit your needs and your budget. In these conversations, bring up your interest in discussing all of the different types of trials and study designs available to you, and get a few opinions on what will work best for your study and your budget. The options discussed here are a great start but they are not an exhaustive list -- and all clinical trial designs will come with their own benefits, challenges, and price points.
Our team of experts will gladly walk you through the process, and if you decide to trust us with your research, we’ll make sure to find a study design that suits your needs. What’s more -- we’ll guide you through the whole trial process and handle everything from study design, all the way through to completion.
Want to Learn more?
Citruslabs provides a simple and affordable way to prove that your products actually work. At Citruslabs, we design a clinical trial that is right for you and your budget, so that 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.