Clinical Trials are research studies conducted with people to find better ways to prevent and treat diseases. Clinical Trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy. In cancer prevention trials, participants may take medicines, vitamins, minerals or other supplements that doctors believe may lower the risk of a certain type of cancer. So, depending on what is being studied, a particular clinical trial may involve patients with a specific disease or people who do not have the disease but are at higher risk than most people for developing it.

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Why Are They Important?

Clinical Trials are important because they often lead to the development of more effective treatments. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Also, if the new treatment proves more effective than the standard treatment, study patients who receive it may be among the first to benefit.

In addition, these studies answer important scientific questions, which can lead to future advances in care. Almost all progress in treatment has been gained through clinical trials.

What are the Phases of Clinical Trials?

The search for new treatments begins in the laboratory, where scientists first develop and test new ideas. If an approach seems promising, the next step may be testing it with animals to see how it affects the disease in a living body and whether it has harmful effects. A research study with people is one of the final stages of a long and careful research process. Clinical trails include research at different phases. Each phase answers different questions about the new treatment.

Phase I trials are the first step in testing a new treatment in humans. These studies evaluate how a new drug should be given (orally, by injection, etc) how often and in what dosage. A phase one trial usually enrolls only a small number of patients.

Phase II trials focus on learning whether the new treatment has an effect (Does it shrink a tumor? Improve blood test results?) These trials provide more information about the safety and benefit of the drug or treatment.

Phase III trials compare the results of people taking the new treatment with results of people taking the standard treatment. Phase III trials typically involve large numbers of people in doctors' offices, clinics and medical centers nationwide. If you participate in a Phase III treatment trial, you are likely to be assigned by chance (randomized) to a group receiving either the new intervention or the standard intervention. Comparing similar groups of people taking different treatments for the same type of disease is another way to make sure that study results are real and caused by the treatment rather than by chance or other factors.

Who Can Participate in a Clinical Trial?

Clinical trials enroll people who are alike in certain ways depending on the study's purpose. Each trial identifies some specific characteristics that people should have in order to participate in the study. These are call eligibility criteria. Eligibility criteria may include the type of disease and its stage, age, and general health.

How are Clinical Trials Participants Protected?

Clinical trials have several procedures to protect the safety of the people who participate. One or more review groups have to approve every clinical trial. For the majority of the trials done at the John Muir Health System, the review groups would include the National Cancer Institute and one of our Institutional Review Committees (IRC). The IRC is composed of physicians, community representatives and members of the Hospital Administration. The IRC serves as a neutral reviewer, ensuring that the study is conducted fairly and that no one who decides to become a participant is likely to be harmed. Each Phase III trial also has a special group called a Data Safety Monitoring Committee that looks at test results, monitors the safety of the participants, and decides whether the study should go forward as originally planned.

Potential participants are given as much information as is known about the risks, benefits, and procedures of a trial before they agree to participate. This is called the informed consent process. Potential participants should be sure they understand the risks of taking part in a specific trial and weigh the risks against the potential benefits as they decide whether or not to enter a clinical trial.

Where Are Trials Conducted?

If you participate in a clinical trial, you may receive your treatment at your local medical center or physician's office, a large cancer center or a university hospital. In the past many patients had to travel to large academic centers in order to participate in a clinical trial. Currently, many trials are open in the community settings and treatments can be administered at local facilities.

In the fall of 2005, John Muir Health system currently has over 25 clinical trials open. Physicians at both hospitals participate in clinical trials. John Muir Mt. Diablo Health System has clinical trials available for oncology, stroke and cardiac patients. We participate in both National Cooperative Group studies through the National Cancer Institute, trials sponsored by pharmaceutical/device companies and trials sponsored by physician or nurse investigators.