It is important for any business in the supplement or pharmaceutical industry to learn why clinical trials are essential and what it takes to perform them. Through dietary supplement clinical trials, supplement brands and businesses can discover the safety and efficacy of supplements on a group’s or individual’s health and well-being. These clinical trials also provide evidence to support the unique health claims of the supplement under consideration. With this in mind, we have put together a guide on what it takes for supplement brands to perform clinical trials.
What are Clinical Trials?
In the supplement space, clinical trials are research studies that are designed to assess the safety, effectiveness, and efficacy of a supplement or drug. Clinical trials are how researchers discover whether new treatments, medicines, or supplements are safe and effective for different populations.
The Food and Drug Administration (FDA) requires supplement manufacturers to carry out clinical trials so that they can provide safe, effective, and high-quality products to consumers around the world. This is especially important for supplement brands and manufacturers to generate scientific conclusions to prove to consumers that the supplement in question is safe and trustworthy. During the clinical trial stages, researchers study a supplement’s side effects, efficiency, and dosage required for maximum effectiveness.
Designing Clinical Trials
Designing a clinical trial is the most important aspect of the clinical trial process. A well-designed and controlled clinical trial will be the most reliable form of evidence to back up your supplement claims. Supplement brands and manufacturers need to make sure that each segment of the clinical trial is well thought of and well-regulated so that the results of the clinical trial are clear and comprehensible. Having a well-designed clinical trial will not only allow for a more productive and efficient process as you start your research study, but it will also allow you to generate more accurate results.
There are several factors that every supplement manufacturer needs to know before carrying out clinical trials. Clinical trials alone can take up to six to seven years because of the different stages and phases within a clinical trial. Before the actual clinical trials, researchers learn more about the supplement ingredients in the discovery stage, which could take up to six years to fully complete. Typically, researchers start their clinical trials by identifying a small-scale cluster of volunteer participants. As the clinical trial progresses and moves into the different stages, the sample size of participants increases, and the efficacy of the supplement becomes more well-known.
Phases of Clinical Trials
There are four phases in a clinical trial. As your supplement trial advances, each stage will involve different test parameters, until the supplement is proven to be safe and effective. Here is a breakdown of what a clinical trial timeline resembles:
In Phase I, a group of 20 to 100 healthy participants are offered the supplement and monitored in groups. Researchers evaluate the safety of the supplement by appraising for any possible adverse side effects. This detailed information is given to supplement brands and manufacturers. Typically, this stage takes up to several months to a year. Throughout this phase, researchers must keep in mind that participants may withdraw from the study due to personal or undisclosed reasons. Supplement brands and manufacturers must constantly communicate to provide quality care to ensure participant retention. At the end of Phase 1, around 70% of these supplements are approved to move forward.
Phase II involves up to 200-300 healthy participants. In this phase, researchers analyze the participants on safety and the effectiveness of the supplements. They collect data that can determine whether the supplements are viably effective in any of their claims and continue to study the supplement for any short or long-term issues. Because of the constant observation, this phase can take up to two years to complete. Supplement brands and manufacturers must be ready for any changes and alterations that might come up during the process. Approximately 33% of these supplements advance to Phase III.
Phase III comprises up to 3,000 participants. In this phase, researchers continue to study the safety and effectiveness of the supplement in different populations. This phase can take up to three to four years to complete. In the meantime, supplement brands and manufacturers should continue to build industry and consumer confidence by staying in the loop and regularly checking on their trial participants and researchers to better understand the results and information being given to them. After this phase, the FDA will review the clinical trial results and determine whether the supplement is approved; only 25-30% of these supplements will make it to the market.
Often called “Post-Approval Research and Monitoring,” Phase IV occurs when the supplement is offered to a large group of people through the supplement manufacturer’s company. Both the FDA and the manufacturer continue to monitor the effectiveness in diverse populations to know whether the supplements are effective. In this phase, the long-term side effects are evaluated.
Potential Clinical Trial Delays
Supplement brands and manufacturers must be prepared to face several delays at any point during a clinical trial. These factors may be within the researcher’s control, whereas other factors may be out of your hands. Here are some common reasons for delays that supplement brands and manufacturers must be aware of:
- Time of completion for writing, reviewing, and editing documents;
- Supplement being studied is not ready;
- Delayed reviews of regulatory documents;
- Recruitment problems;
- Testing, data-entry, data analysis, and clean-up delays; and
- Trial scope changes.
It is important for supplement brands and manufacturers to be aware of these potential barriers and delays that may arise so that they can prepare a potential action plan to figure out the next steps. Having an action plan in place will be crucial to overcoming these setbacks. Additionally, brands and manufacturers must regularly communicate with the researchers of the clinical trials to be aware of all the potential issues that may arise.
Clinical Trials are important in the supplement industry. Supplement manufacturers should be aware of the implications of performing clinical studies for their supplements. If you need any assistance navigating clinical trials, please contact Paragon Laboratories. We can connect your supplement brand with industry-leading Contract Research Organizations to begin your clinical trial.