What Is a Clinical Trial?
Why Are Clinical Trials Important?
Why Would a Patient Be Interested in a Clinical Trial?
Are There Risks or Side Effects in Clinical Trials?
What are the Phases of a Clinical Trial?
What Clinical Trials are Presently Ongoing at UCLA?
Whom Can I Call for More Information?
Are There Additional Resources?
The search for viable treatments begins with basic research in laboratory and animal studies. The best results of that research are then used in patient studies, hopefully leading to findings that may help many people.
Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed, and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with patients. (Top)
Advances in medicine and science are the result of new ideas and approaches developed through research. New treatments must be proven safe and effective in scientific studies with a certain number of patients before they can be made widely available. (Top)
The patients in a clinical trial are among the first to receive new treatments before they are widely available. How a treatment will work for a patient in a trial cannot be known ahead of time. Even standard treatments, although effective in many patients, do not carry sure benefits for everyone.
The patients who take part in clinical trial procedures that prove successful have the first chance to benefit from them. All patients in clinical trials are carefully monitored during the trial and follow-up period afterward. And because trials are often funded by outside sources, there is no out of pocket expense to the patient. (Top)
However, any medical treatment can carry the potential for side effects in some patients. Because clinical trials are research into new areas of treatment, the risks and side effects involved are not always known ahead of time, though efforts have been made to find out what they might be. Patients should be sure they understand both the possible risks and benefits before deciding if they want to take part in a study. (Top)
Phase I: Phase I includes the first studies conducted on humans, after the animal studies are completed. They usually include a limited number of patients and focus on safety and toxicity (Maximum Tolerated Dose).
Phase II: Phase II generally includes more patients and aims to confirm the results of Phase I and establish the therapeutic value of the treatment.
Phase III: Phase III often includes hundreds of patients, focuses on safety and the efficacy of the treatment as compared to that of the currently used standards of care, and are mostly randomized trials. They often involve a placebo and may take place in multiple locations, some on an international basis. (Top)