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 UCSF Helen Diller Family Comprehensive Cancer Centers
Protocol Review Committee, which ensures that the study will
yield useful data and answer the questions it has raised. UCSFs
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.