Text Box: WHAT IS IT LIKE TO BE IN A CLINICAL TRIAL? If you are taking part in a clinical trial you will receive treatment in our office in the same room with other patients who may or may not be in a clinical trial. Your doctor, treatment nurse, nurse practitioner and nurse research coordinator will all be part of your treatment team. Everyone on your team will follow your progress closely. If you are in a clinical trial, your well being is just as important as the clinical trial. To help protect you and to produce sound results, clinical trials are carried out according to very strict scientific and ethical guidelines. Clinical trials have an action plan called a Protocol that explains how the trial works. This plan explains what will be done in the trial and why. It outlines the number of people who will take part, what medical tests will be needed and how often, and the treatment plan. The same protocol will be used for each patient that takes part in the trial. For patient safety, each protocol must be approved by an Institutional Review Board. This board includes consumers, clergy and health professionals. They review the protocol to try to be sure that the clinical trial will not expose patients to extreme or unethical risks. The protocol for a clinical trial describes the characteristics that all patients in that trial must have. These characteristics are guidelines called eligibility criteria and they differ from trial to trial depending on the purpose of the trial. These guidelines often include age, gender, the type and stage of the cancer, and whether there have been prior treatments for cancer or if there are health problems that may prevent a patient from taking part. The eligibility criteria are an important principle of a clinical trial. They help produce reliable results and protect patient safety, so that patients who are likely to be harmed by the study drug or treatments are excluded from the trial. When all the results are in, eligibility criteria for the study helps the doctors to know which patient groups will benefit (if the new treatment being studied is proven to work). For example, a new treatment may work for one type of cancer but not for another, or it may be more effective for men than women. By participating in a clinical trial you play a more active role in your own health care. You have access to new treatments before they are widely available, and the data obtained from your participation helps researchers develop new and more effective treatments for future generations of cancer patients. ~The Peninsula Cancer Institute Research Department