Frequently Asked Questions

And Answers

• A clinical trial is a study conducted with actual patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help patients. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more information is gained about a new treatment, its risks, and how well it may or may not work.

  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)

Why Are Clinical Trials Important?

• Through clinical trials, researchers learn which approaches are more effective than others. This is the best way to test a new treatment. A number of now-standard treatments were first shown to be effective in clinical trials. These trials helped to find new and better treatments.

  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)

Why Would a Patient Be Interested in a Clinical Trial?

• Patients take part in clinical trials for many reasons. They may hope for a cure to a disease, a longer time to live, or a way to feel better. And some patients want to contribute to a research effort that may help others.

  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)

Are There Risks or Side Effects in Clinical Trials?

• Yes. The treatments used in clinical trials can cause side effects and other health risks depending on the type of treatment and the patient's condition. Side effects vary from patient to patient. Some side effects in clinical trials can be permanent and serious, even life-threatening. Also, certain side effects may not appear until later, after the treatment itself is over.

  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)

What are the Phases of a Clinical Trial?

• Clinical trials generally have three phases:

  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)

Whom Can I Call for More Information?

• For information on inclusion and exclusion criteria, call Nazy Zomorodian, Administrative Director for the Clinical Trials Office at (310) 825-5538.