Eligibility and Enrollment
Before a patient is enrolled in a clinical trial, the individual is carefully screened against a set of criteria designed to identify a group of people that are as similar as possible. Qualification for a trial depends on a variety of factors including stage of disease, existing health conditions and other factors.
The patient then goes through what is known as “informed consent” where the goals of the trial, why it is needed and how it will work are explained in easily understandable terms.
Patients should take the time to discuss all the details of a clinical trial with their doctor and family before agreeing to participate. Questions to consider include information about costs, time commitments, and potential benefits as well as side effects. This may vary, based on where the new therapy or tool is in the development and testing process (phases).
- Phase I and phase II trials focus primarily on safety of the new treatment. Phase I trials are investigational and therefore include a very small number of people—no more than 50. The goal is to determine safe medical dosage, the best method of delivery (for example, a pill or fluids) and potential side effects. Phase II trials seek to determine if a new therapy has a specific effect on a certain type of cancer in a slightly larger population group of less than 100 people. To learn more about UC’s phase 1 clinical trials unit, click here
- Phase III, IV and V trials focus on larger-scale testing to compare the investigational medical treatment to the standard of care and further assess its long-term safety and effectiveness. These trials may require a longer time commitment and more paper surveys.