Volume 1, Number 1 ----- Spring/Summer 1998

What is a Clinical Trial?

A clinical trial is a research study conducted with people. Clinical trials are the primary method of advancing medical knowledge. They range from studies to detect a disease, like the PLCOCancer Screening Trial, to studies to prevent and treat a disease.

Before a clinical trial begins, researchers develop a precise action plan or "protocol." The protocol must be approved by the organization that sponsors the study (such as NCI) and the Institutional Review Board (IRB) at each hospital or other study site. This board, which includes consumers, clergy, and health professionals, reviews the protocol to be sure that the research will not expose participants to inappropriate risks. In PLCO, there is an independent monitoring and advisory panel that continues to monitor the study to ensure the safety of the participants.

People from all parts of the country and of all ages and ethnic backgrounds volunteer to take part in clinical studies. Before they begin the study, participants are given all the facts about the study including possible risks. This process is called informed consent. Participants are never pressured to join or stay in a study. If at any time they feel uncomfortable about their participation, they can leave the study.

The Breast Cancer Prevention Trial (BCPT) is an example of another important NCI-supported clinical trial. More than 13,000 female participants recently helped show that the drug tamoxifen can dramatically decrease the occurrence of breast cancer. As a result of this clinical trial, women at high risk for breast cancer now have a powerful new option for preventing the disease.