STUDY PARTICIPANTS

Clinical trials (also called clinical research studies) are strictly regulated by the FDA and are conducted in several phases (Phase 1-4) in order to test how safe and effective a drug and/or device is.

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• Phase 1 trials are usually conducted in a small number of healthy volunteers after the completion of pre-clinical animal studies. These trials attempt to find the safest dose by observing drug absorption, distribution, metabolism, and excretion. Study participants in phase 1 trials are closely monitored for adverse side effects.

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• Phase 2 trials can be conducted in up to several hundred volunteers with a specific disease or condition, collects additional safety data, and looks to identify if the drug and/or device being tested is actually working as intended.

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• Phase 3 trials continue to research the safety and efficacy of an investigational product (IP) in much larger groups of volunteers. After phase 3 is completed, all research data collected can be submitted to the FDA for approval. If approved, the drug and/or device can now be prescribed by your physician.

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• Phase 4 trials are aimed to collect additional safety and efficacy data on already approved drugs and devices. It's important to note that clinical trials are completely voluntary and participants can withdraw at any time.

 

What can I expect at my first visit?

First, you will review and sign an informed consent form (ICF) explaining everything you need to know about the study and your rights as a trial participant. After the ICF is signed, researchers will verify you meet all eligibility criteria. This usually involves the collection of your medical history, demographics, current medications, and a physical examination. Oftentimes, blood tests and urine pregnancy tests are also performed to make sure you're a good fit to participate.