A Cancer Prevention Trial is a research study about how to improve health and health care. Chemo-prevention trials are designed for people who have not previously had cancer. In prevention trial people take medications, vitamins, minerals or other supplements that scientists believe may lower a persons risk for developing a certain type of cancer.
Testing for safety and effectiveness is done in Phases. Phase I testing is done to test for the proper dose and route for the new prevention agent. Close observation is done of check for side effects of the new agent. Phase II observes for the biologic effect in preventing cancer. Phase III compares the new agent to standard practice, which may be no agent or a placebo.
To partake in a prevention clinical trial, a patient must first be eligible for the trial. Each protocol has a list of criteria that must be met before the person can participate. To find more about a prevention trial, a person can attend an informational session or come to the clinical trials office. The person agrees to hear more information about the trial through an informed consent. The risks and benefits of enrolling in the trial ere reviewed. The eligibility checklist is reviewed with the patient, to make sure that he can enroll in the study. The consent form is then signed. If additional testing is required, arrangements are made to complete the test. The patient is enrolled in the study.
A process called randomization assigns you to a treatment group or the control group. A double blinded study is one in which neither the doctor nor you will know which group is assigned. The patient is assigned a number to identify information that is submitted about his or her response to the medication or supplement. Confidentiality is maintained to protect the patients' personal information.
The rights of the clinical trial patient on a prevention study are guarded very closely. The pros and cons of the study are reviewed before the patient enters the trial. At any time the patient can withdraw from the trial if there are some barriers with participation. Taking part in a prevention study is voluntary.