Wouldn't it be great to volunteer for the clinical trial on the effects of dark chocolate on insulin sensitivity that the National Center for Complementary and Alternative Medicine has been conducting? That might seem like fun, but most clinical trials are extremely serious and not something to take lightly. They are programs that study or test if different drugs, treatments or devices are safe and effective for people to use. Deciding whether or not you should participate in one should be considered carefully.

Types of trials

Approximately 50,000 clinical trials are currently going on in the United States. The four main types are:

• Treatment trials, which study specific drugs, treatments or new methods of treatment.
• Prevention trials, which study medicines, supplements or exercises that may lower the risk for developing certain diseases.
• Screening trials, which test the best methods for screening for certain diseases.
• Quality of life trials, which study the benefits of treatments or lifestyle changes that may improve quality of life.

Are they right for you?

A 2005 Harris Poll found that 30 percent of adults who participated in clinical trials did so to obtain education about treatment or improving their health, while one in four did so because the information they read, saw or heard about the study influenced them. In addition, 84 percent of participants in previous studies said they would do it again if given the chance.

If your doctor has suggested you consider joining a clinical trial, or if you have heard about one that interests you, it's important to do your homework. Clinical trials allow you to participate in research that can provide important medical data to help not only those people in the study, but also those who will benefit from what is learned from the trial. These studies also allow participants to have access to new types of treatments that are not yet readily available to the public.

It is important to consider potential risks. Participants may experience side effects or risks that researchers are not aware of when the trial begins. Since participants do not have the right to choose which treatment they will receive, they may be in the control group meaning they do not receive the treatment being studied. Not everyone benefits from the treatment. Participants may have to see the doctor more often than usual. Finally, health insurance may not cover treatment.

Asking the right questions

Check out "Miracle Cures - What You Need to Know About Clinical Trials " on this Web site for additional information on clinical studies.

If you decide to participate in a clinical study, you have a right to ask very detailed questions about the study and what is expected of participants. Here are some specific questions you may want to ask:

• What is the purpose of the study? What are researchers trying to learn from it?
• Who may participate in the trial?
• What previous studies have been conducted that make researchers believe the trial will be effective?
• Who will be in charge of my care?
• What are my responsibilities during the trial?
• Will I have to stop taking any of my usual medications during the trial?
• Are there other treatment choices I should be aware of?
• What kinds of tests and procedures will I undergo?
• What are the possible risks, side effects and benefits associated with this trial that are different from those my current medication, device or treatment have?
• How long will the trial last and how much time will it involve?
• Is there any long-term follow-up care being offered?
• Will I be provided with the results of the trial?
• Who pays for this treatment? If my insurance does not cover it, will I be reimbursed for my expenses?

Leaving the trial

As a participant in the study, you are allowed to leave at any time. However, participants are usually asked to share their reasons for leaving to the researchers so they can be aware of any problems there may be in the trial.

Who pays?

A study in the June 2003 Journal of the American Medical Association found that the costs of treating cancer patients in clinical trials was just slightly higher than treating similar patients outside of trials.

Check with your health care provider to see if they will cover your costs of participating in the clinical trial. Many states require that health plans pay any expenses of routine medical care you receive while participating, such as doctor visits, hospital stays, laboratory tests and x-rays. You will need to check with your state to see exactly what laws apply.

In 2002 Medicare began covering beneficiaries' costs in clinical trials. Its Web site can provide you with information about what this coverage includes: http://www.medicare.gov/Coverage/Home.asp.

For Further Information You May Consult the Following:

• CenterWatch by Thomson Corporation can be found at http://www.centerwatch.com/patient/trials.html