Before new medical therapies can help patients, they must first be tested with healthy volunteers in Phase I clinical trials. A Phase I trial aims to find out any safety issues and determine appropriate dosage levels. Researchers need to see how the body tolerates the new substance and record any side effects that may occur as dosage levels are increased.
Clinical study protocols, or research plans, are designed to protect participants from undue risk. Protocols are carefully reviewed by an independent ethics board to ensure that the drug is safe and not likely to harm volunteers.
Under a physician’s supervision, volunteers who are generally healthy receive potential treatments under investigation. This process will add to scientists’ understanding of the way the body processes the drug and any side effects that may occur.
Volunteers start taking a minimal dose and are closely observed as the dose is increased. This process helps researchers determine the optimal dosage levels that the body can tolerate. They will also record your medical history and vital signs. You will probably be asked to give blood and urine samples for analysis, but every trial may have different requirements.
Interested in volunteering for paid clinical trials?
Healthy volunteers in a Phase I trial are generally compensated for their time and contribution to finding out more about promising new drugs. These trials are relatively short - your time commitment may be just a few days. But your participation could make the difference for someone in need of life-changing treatments.