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).
These 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.
These 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.
Stringent patient protections implemented to ensure safety and ethical conduct are monitored by an Institutional Review Board, a governing committee made up of physicians, scientists and members of the community responsible for scientific review and approval of all clinical research studies. Other medical monitoring groups are in place to ensure medical oversight and ethical conduct throughout the clinical research process.
For more information, contact:
Robin Dobbins RN
Senior Oncology Nurse
Clinical Trials Office
Office: (706) 721-2154