Prior to licensing and becoming available for prescription use, new pharmaceutical medications first need to undergo the clinical trial process. The initial phase of trials, commonly referred to as Phase 1 clinical trials, evaluate a drug for its safety and effectiveness. Through these trials, medical researchers are able to determine the safety, and optimal dosage, along with the potential side effects and adverse reactions associated with the drug under consideration.

Periodically, pharmaceutical drug manufacturers will modify or enhance a medication or treatment. In cases where this occurs, these medications and treatments are not automatically licensed or made available for prescription. Instead, they have to work their way through the entire clinical trial process all over again, beginning with Phase 1 clinical trials.

These clinical trials, conducted on a select group of volunteers who remain on location throughout the course of the trial period, can last anywhere from one to 30 days. During this time period, the drug being evaluated is initially administered at a minimal dosage. Over time, the dose is progressively elevated making it possible for researchers to examine the effectiveness, optimal delivery method, and safety of the drug.

Why Are Volunteers So Important?

Volunteers are essential for Phase 1 clinical trials in order to analyze the safety and effectiveness of new drugs for human usage. As a result of becoming involved in clinical trials, individuals have the opportunity to contribute to medical technology and scientific research. Additionally, volunteering for clinical trials enables an individual to help many people by assisting researchers as they perfect medications and medical treatments.

Volunteer Requirements

All volunteers for a clinical trial must be in good health and initially pass a medical assessment known as a screening visit. Volunteers who are unsuccessful in the screening visit phase of the program cannot partake in the clinical trial. Various other demographic criteria such as the age, sex, and weight of the volunteer also determine whether or not the volunteer is an ideal candidate for the clinical trial.

To finance the traveling expenses to the Clinical Research Unit for the trial, volunteers receive up to £100 after acceptance into the program. Volunteers presently involved in, or who have recently participated in any clinical trials, are not eligible to participate in additional trials. Individuals who have recently participated in a clinical trial, need to wait until at least three months have elapsed since their last clinical trial, before being eligible to engage in any other trials.

This article was written by Nick Davison, of Covance Leeds CRU, To read more of Nick’s work, check out the Covance CRU blog.