Why Clinical Trials?

A clinical trial is a research study with formal controlled protocols designed to test ways to prevent, diagnose, or treat a disease. Clinical trials are formal studies designed to test the effectiveness of new treatments and answer very specific questions about a particular treatment strategy. Clinical trials are a final stage of the long and careful cancer research process, where patients help doctors find ways to improve health care.

Major advances in health care have occurred because of clinical trials. Treatments proven effective by clinical trials are now standard procedure. Each trial protocol has parameters specifying the treatment to be studied, eligibility criteria, and what information will be gathered. A trial may focus on quality of life; disease prevention, including behavior modification; early detection and screening; or disease treatment, including new drugs, new approaches to treatment, or new methods.

Disease treatment trials that involve the use of a new drug are divided into three phases. Phase 1 trials evaluate how a new drug should be given, including dosage and delivery. Phase 1 trials involve a small number of patients. Phase 2 trials evaluate how well a new treatment works, typically involving 100 to 300 patients. Phase 3 trials compare new strategies to approaches already in use. Large numbers of participants are randomly selected to receive the new treatment or the standard one. The use of phases protects patients and results in valuable new information.

Before a clinical trial is made available to patients at UCSF, its protocols must be reviewed and approved by the appropriate committees. The Urologic Oncology Protocol Review Committee evaluates and prioritizes urology cancer protocols. The members of this committee represent all relevant specialties, and include patient advocates. Approved protocols are then evaluated by the Comprehensive Cancer Center‘s Protocol Review Committee, which ensures that the study will yield useful data and answer the questions it has raised. UCSF’s Committee on Human Research is comprised of members from across all schools and many disciplines, and includes an advocate from the community. The committee considers the ethics and risks associated with every study proposed at UCSF. A committee appointed specifically for each trial constantly monitors safety and data.

By performing clinical trials, the Department of Urology accomplishes specific goals stated in our mission statement. Clinical trials allow the department to provide innovative care to all patients, to ask relevant questions and answer them with scientific knowledge, to train the future leaders of the field, and to work together responsibly and ethically. Improvements made in clinical care for urologic disorders at UCSF are shared with other health professionals and yield improved health care worldwide. For more information, please contact the urology clinical trials office staff.

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