What are the parts of a clinical trial?

According to the National Cancer Institute, clinical trials are research studies that test new ways to prevent, detect, diagnose or treat cancer and other diseases.

While there are several different types of research involved in clinical trials, such as prevention research, screening research and survivorship research, most people are referring to treatment research when they ask about clinical trials. Treatment trials test new treatments, such as cancer drugs, new methods of administering treatments or new combinations.

Clinical trials can be performed in anywhere from three to five phases:

PHASE 0 TRIALS: These studies use very small does of the drug to see how the body reacts to it, if it reaches the tumor and how it is expelled from the body. These studies will have few participants, and can be healthy individuals.

PHASE I TRIALS: These studies evaluate how a new drug should be given, how often and what dosage is safe. They generally have 20-30 participants, though they can have up to 100 and participants might also be healthy individuals.

PHASE II TRIALS: These trials continue to evaluate the safety of the new drug while also evaluating how well the new drug is working, usually just on one type of cancer. Usually have a slightly larger number of participants than the first phase had.

PHASE III TRIALS: These trials test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard of care. These trials can have hundreds to thousands of participants.

PHASE IV TRIALS: These trials are used to further assess the long-term safety and effectiveness of a new treatment and usually begin when, or shortly after the drug is placed on the market.

For more information contact Courtney Britton, librarian at Cancer Services of Greater Baton Rouge at (225) 927-2273, cbritton@cancerservices.org , or visit the Education Center at 550 Lobdell Ave., Baton Rouge.

ä ON THE INTERNET:

ASCO — Understanding Cancer Research Studies

cancer.net

NCI — Taking Part in Cancer Treatment Research Studies

cancer.gov

ACS — Clinical Trials: What you Need to Know

cancer.org

FDA — Learn about Drug and Device Approval

patientnetwork.fda.gov/

This column is presented as a service by Cancer Services of Greater Baton Rouge, a United Way affiliate.