What is a clinical trial?

A clinical trial is a research study carefully designed to determine whether a drug candidate is safe and effective. Clinical trials are conducted in humans after a thorough review of initial laboratory and animal testing. The Food and Drug Administration (FDA) will then conduct a comprehensive review of the safety and efficacy of these clinical trials prior to approving the drug to commercialize, or become available to physicians and their patients. Clinical trials are also overseen by Institutional Review Boards (IRBs), or Ethics Committees (ECs). An IRB or EC is an independent group that ensures the safety of patients participating in any type of research.

What are clinical trial "phases"?

Clinical trials are conducted in "phases" or steps. Each phase is conducted to answer a specific research question. The following are brief descriptions of the three key phases of clinical trials:

Phase 1: An investigational drug may be tested in a small group of patients for the first time to evaluate its safety, determine a safe dose range, and identify any potential side effects.

Phase 2: An investigational drug may be tested in a larger group of patients, who typically have the same disease. Phase 2 studies are designed to further evaluate safety and activity of the drug, as well as identify the optimal dose and schedule for administering the investigational drug.

Phase 3: An investigational drug may then be given to large groups of patients to confirm its effectiveness, monitor side effects, and collect information that will allow the drug to be used safely. These studies often compare the investigational drug to either placebo or standard of care. The Phase 3 trial will also further evaluate the safety of the investigational drug and may be the final step in the drug development process prior to seeking regulatory approval for commercial sale of the drug.

How do I decide if a clinical trial is right for me?

Choosing whether or not to participate in a clinical trial can be a difficult decision. It is very important to have a clear understanding of the clinical trial that you are considering. Patients considering clinical trials should speak to their physician. In addition, for more information about clinical trials visit www.clinicaltrials.gov.

When you enroll in a clinical trial, you always have access to the Institutional Review Board (IRB) or Ethics Committee (EC) to ask questions or if you have concerns of any nature.