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Considering a Randomized Controlled Trial? Here's What You Need to Know!

If you're on the brink of initiating a Randomized Controlled Trial (RCT) for your product, you're aiming for the gold standard of clinical trials. RCTs are renowned for their rigor and are extensively used to determine the effectiveness of new treatments, supplements, or health interventions. Here are some essential insights to ensure your trial is set up for success and to help you understand the implications of the outcomes. BTW, if you're wondering, "What the heck is an RCT?" You might be familiar with the term double-blind placebo-controlled trial. This study design is part of the RCT family.

Different pills on a white background

Randomized Controlled Trials: The Gold Standard

Randomized Controlled Trials (RCTs) are considered the gold standard in the world of clinical research due to their ability to minimize bias. In an RCT, participants are randomly assigned to either the intervention group or the control group, ensuring that each group is similar in all respects except for the intervention being tested. This setup helps isolate the effect of the intervention from other variables.

Recognizing the Placebo Effect

It's important to acknowledge the placebo effect—a phenomenon where participants experience a perceived or actual improvement in their condition solely because they believe they are receiving an active treatment, even when they are not. The placebo effect is a real and potent force that can influence the outcomes of your RCT, potentially masking or mimicking the true effect of the product being tested.

The Reality of Statistical Significance

One crucial aspect to prepare for is the possibility that your RCT might not show a statistically significant difference between your product and the placebo. When conducting RCTs, it is crucial to set realistic expectations about what your supplement can and cannot achieve. Historically, about 75%-80% of drug trials do not achieve statistically significant results due to efficacy issues, often failing to demonstrate a meaningful difference between the drug and the placebo. As you can see, this is a common challenge across ALL clinical trials. At Citruslabs, we often see brands trying to go after treat or cure claims, which is not only regulatory overreach—as supplements cannot legally make these claims—but also significantly lowers the likelihood of observing a statistically significant result. Setting realistic goals for what your product can achieve and maintaining transparency about its capabilities will help align your trial's objectives with achievable outcomes. This doesn't mean that supplements can't have a tremendous effect on an individual's health, but often the effects that are observed in a supplement are subtle, which is often all that many individuals need.

Publishing Your Randomized Controlled Trial in a Scientific Journal

RCTs open up the opportunity to publish your findings in a scientific journal. Publishing your study not only contributes to the broader scientific community but also enhances the credibility and visibility of your product. When preparing your manuscript, ensure that your study is reported with transparency and includes all relevant data. Getting your RCT published in a peer-reviewed journal increases the credibility of your research because only high-quality and reliable studies stand the test of peer review. This can potentially influence future research and development in the field and help position your brand as a leader in evidence-based practice.

Setting Up Your Study for Success

To maximize the success of your RCT, it's important to set clear goals for your study. The easiest way is to work backward: create a wishlist of claims and then talk to your CRO (contract research organization, like Citruslabs) if and how you can realistically achieve these claims. Here are some strategies to ensure your study is well-planned and focused:

  • Avoid a "spray and pray" approach: This is probably the NUMBER ONE mistake we're seeing at Citruslans. And we get it! Clinical studies are expensive, especially RCTs, and you want to get as much ROI out of this study as possible. However, packing multiple studies into one can dilute the focus and weaken the impact of your findings. Want to test energy, focus, attention span? No problem! Want to add the impact on hair and skin health? And sleep? And IBS symptoms? You should consider splitting these studies so as not to lose your focus. Don't measure everything and nothing.

  • Clear Objectives: Define clear, specific, and achievable objectives. What exactly are you testing, and what are the expected outcomes? Start with your reviews. What are they truly saying? What does your product truly help with? And keep in mind the placebo effect that these individuals might be observing.

  • Appropriate Sample Size: Ensure your study has enough participants to detect a meaningful difference if one exists. While everyone familiar with biostatistics would probably revert to so-called power calculations, it can be difficult to do them for supplements that have not been tested before. The "effect size" is typically missing, and researchers often guess it. A good rule of thumb for health & wellness products is that at least 30 participants per arm complete the study. On the other hand, when the sample size is too large, your study is overpowered. In this scenario, while you likely get a statistically significant result, it might not mean anything (i.e., it's clinically irrelevant).

  • Right Duration: The duration of the trial should be sufficient to observe the intended effects and allow for any delayed responses to manifest. If you don't know where to start, 8-12 weeks is typically a good study duration. If you're unsure, ask the experts at Citruslabs.

  • Robust Methodology: This refers to a) blinding and randomization (ideally, the two products are indistinguishable, and every study subject has the same chance to get randomized in every study group). And b) this refers to how you collect your data. In particular, questionnaire-based studies are prone to observing the placebo effect. Once you include biomarkers, like bloodwork, microbiome testing, or expert skin/hair grading, for example, there is less bias from the study subjects.

  • Ethical Considerations: Maintain high ethical standards. Participants should be fully informed about the trial, including any risks and their right to withdraw at any time without any consequences.

RCTs can provide valuable insights into the efficacy of your product if they're done right. By understanding the challenges and setting up your trial with precision, you can significantly enhance the likelihood of obtaining clear and actionable results. Remember, a well-conducted RCT not only adds to the scientific understanding of your product but also builds credibility and trust with your stakeholders.

Ready to conduct your RCT with Citruslabs? Contact us HERE.


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