Q. How do I know if a clinical trial is right for me and my chronic illness?
Participating in a clinical trial can place you in the care of some of the nation's top physicians, and you may find a treatment that works. Naturally, you also are concerned about the risks involved.
A clinical trial is a medical investigational study in which humans are observed and/or treated. The type of trial you might be interested in is a treatment trial which tests new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Treatment trials are generally conducted in phases. This is what happens during each phase:
Phase I is the first time humans receive the new drug or other treatment under investigation.
In Phase II, the safety and effectiveness are studied in volunteers who have the condition for which the treatment is being considered.
Several hundred to several thousand people may be enrolled in Phase III clinical trials. These trials are conducted over a period of years in hospitals, medical centers, and private physicians' offices across the United States. They also are conducted by large medical centers and government-supported organizations, such as the NIH (National Institute of Health) and the Veterans Administration.
In Phase III, the investigational treatment is compared to a standard therapy currently used to treat the condition and the overall benefits and risks of the treatment under investigation are evaluated. The data gathered from Phase III trials provides a better understanding of the treatment's effectiveness, benefits, and potential side effects.
Volunteers are divided into two groups: a Control Group and a Study Group. The volunteers in the control group do not receive the investigational treatment. They receive either a currently accepted treatment or a placebo. The volunteers in the study group receive the treatment under investigation.
Once Phase III testing is complete, a pharmaceutical company can submit a drug to the FDA. The FDA uses the data to help determine whether or not to approve the drug.
Phase IV trials are not always conducted. When they are, they usually take place after the treatment receives FDA approval and is available to the public. During a Phase IV trial, long-term safety and effectiveness, side effects that may not have been apparent during Phase III, and optimal usage are evaluated. Hundreds to thousands of volunteers may participate in a Phase IV trial.
Clinical trials have eligibility guidelines for volunteers. This ensures that the study's questions can be effectively answered. The primary benefits of participating in a clinical trial are:
•Gaining access to new treatment before it is widely available
•Possibility of being placed in the care of some of the nation's top physicians
•Helping contribute to medical research that may one day benefit many patients
•Many costs may be covered by a federal program or pharmaceutical sponsor
Drawbacks to participating in a clinical trial include the possibility of:
•Unpleasant, serious, or even life-threatening side effects
•Receiving a placebo or standard treatment rather than the investigational treatment (Volunteers agree to this risk when they consent to participate in the study.)
•Receiving treatment that is ineffective
•Assuming responsibility for many costs (Costs are not always covered by health insurance or a sponsor.)
•A greater time commitment since participation may require more of the volunteer's time than a standard treatment due to trips to the study site, possible need for more frequent observation or treatment, hospital stays, and other factors
Duration varies and depends on the time required to test the study hypothesis adequately. A clinical trial can last a few days, several weeks, or years. In a randomized control trial, a volunteer may be asked to return for follow-up testing for several weeks or months after the treatment phase is over. The volunteer's time commitment will be specified in the public notice for the clinical trial.
To find clinical trials conducted by an authoritative sponsor, you should talk with your doctor and/or contact large medical centers and pharmaceutical firms regarding any trials they may be conducting or planning in the area of your interest.
You can also search the Internet. Visit the websites of medical centers, pharmaceutical companies, FDA, and government-sponsored research centers, such as the NIH. Information on clinical trials sponsored or approved by the NIH and FDA is available at ClinicalTrials.gov.
NANCY TURNEY received a bachelor's degree in social work and a certificate in gerontology. If you have a specific question you would like answered in this column, e-mail it to firstname.lastname@example.org or call Turney at the Crescenta-Cañada YMCA, (818) 790-0123, ext. 225.