Getting involved in clinical research is a fantastic way to contribute to the development of new consumer products, including supplement and vitamin formulas. It can be somewhat daunting to begin the process if you aren’t sure what to expect, so we have compiled some general guidelines for volunteers joining supplement clinical trials for the first time. Many people can be deterred from participating in research because of the rampant misconceptions about the process, making it all the more important to go in with realistic expectations.
The Importance of Supplement Research
Supplement clinical trials are essential for the development of new formulas which are safe and effective for consumers to use. They also help brands to support their product claims. By volunteering in these trials, you contribute to the industry-wide trend of backing up performance claims with actual clinical evidence. In turn, you support innovative new product development and more ethical, responsible supplement marketing.
The Supplement Research Process, Made Easy
Before you begin volunteering for supplement clinical trials, it is important to know where to look for trials that are suitable for you. Some places to start looking include:
Clinical trial databases: Here you can find ongoing and actively recruiting trials that you may be eligible for. In the US, a great first stop is the ClinicalTrials.gov platform, which operates based on location and type of trial.
Social Media Groups: There are a wealth of groups online where you can find health and wellness-related research opportunities. You can find ongoing trials here, or get in touch with research organizations and other volunteers in order to secure future openings.
The Screening Process:
The first step of the clinical trial process is a screening which determines your eligibility. This can take place with a contract research organization after you have expressed general interest in volunteering, or once you have been selected for a specific trial. This step is the foundation for safety in supplement trials. This is especially important when testing products related to a specific well-being concern. For instance, supplements that target sleep should be tested by those with the targeted symptoms in order to obtain accurate results.
Expect to go through a series of assessments which can range from online questionnaires to in-person physical examinations. With decentralized and virtual trials on the rise, at-home biomarker assessments are becoming increasingly common. For example, you may be mailed a kit to complete a fingerprick blood test from your home.
Informed Consent:
Before participating in any clinical trial, you will be required to provide informed consent. This is a crucial legal and ethical requirement that ensures you understand the purpose, procedures, potential risks, and benefits of the trial. Take the time to read and comprehend all the information provided, and don't hesitate to ask questions to the research team. Your voluntary participation hinges on informed consent, which ensures you are fully aware of what you are getting into.
Trial Procedures and Expectations:
Supplement clinical trial procedures can vary widely. The type of product being tested as well as the demographics of the volunteers will determine the duration and intensity of the specific study design. Typically, participants are randomly assigned to different groups, such as a placebo or an active supplement group. This may look slightly different if you are volunteering for a consumer perception trial. This kind of research involves trying out a new supplement product and providing feedback on your experience, including any health benefits you noticed or overall feedback about the product (e.g., packaging, flavor if applicable, any unpleasant effects.)
It's important to follow the trial procedures diligently, which may include taking the assigned supplement at specified times, maintaining your existing diet and exercise routine, or regularly responding to check-in questionnaires online. Your research team will provide clear instructions and be available to address any concerns or questions throughout the trial.
Monitoring and Safety Measures:
During the clinical trial, your health and well-being will be closely monitored by the research team. They will conduct regular check-ins, may collect biomarker samples for analysis, and assess your response to the supplement or vitamin formula being tested. If you experience any adverse effects or have concerns, it's crucial to communicate them promptly to the research team. Your safety is a top priority, and the trial will be conducted with strict adherence to ethical guidelines and safety protocols.
Want to create your own clinical trial?
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 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.