Frequently Asked Questions about Clinical Studies

What is a clinical study?

Clinical studies are research studies in which new therapies and treatments are tested in patients to determine if they are safe and effective. By participating in clinical trials, patients can contribute to medical research while helping to improve treatments and care for others.

Why are clinical studies important?

Clinical studies are necessary because they provide a means to:

• Develop new treatments that can be safer or more effective than currently available drugs.
• Enable researchers to discover new uses for drugs already on the market.
• Make it possible to develop new treatments when no other treatment is available.

Why participate in a clinical study?

Participants in clinical studies can gain access to new treatments before they are widely available. In addition, participants may help other patients by contributing to medical research.

Who can participate in clinical studies?

All clinical studies have guidelines limiting participation. Guidelines can include age, gender, the type and stage of a disease, previous treatment history and medical conditions. Clinical studies may want participants with certain illnesses or conditions to be studied, while other studies may need healthy participants.

What are my rights if I take part in the study?

Participation in a clinical study is completely voluntary. Before joining a study, a volunteer will receive an informed consent form, which provides detailed information about the treatment, the required visits to the physician and any procedures that may be done during the visits. These study visits are pre-scheduled according to the study protocol, or a written set of rules that guide the conduct of the study.

Study participants have the right to withdraw their consent at any time during the study. During the course of a clinical study, a patient is provided with any new information that may affect his/her decision to continue participation in the study.

How is the safety of study participants protected?

Study protocols, informed consent forms, and the progress of clinical studies are reviewed, approved and monitored by the UC Irvine Institutional Review Board (IRB) and the physicians conducting the clinical study. The primary goals of the IRB are to protect the public, to determine whether the possible benefits of participating in the study outweigh the risks and to ensure that patients are not pressured into participating in clinical studies.

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