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Should you join a research study?

Like legions of earlier volunteers, you could contribute to the quest to improve care for people with heart disease.

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Image: Wavebreakmedia/Thinkstock

Imagine getting a letter from a physician based at a nearby academic medical center, telling you about research under way at the institution. It says you might be eligible to participate in a clinical trial designed to test a new blood pressure drug. Or maybe it’s a study on the exercise habits of people ages 65 and older.

You’re curious, so you check the box indicating that you’re interested in learning more and mail it back.

Nothing obligates you to join a study, but it’s an option worth examining. “If you participate in a study, you’ll be advancing scientific knowledge to help the next patient like you. In fact, you’ve already benefited from all the people who took part in earlier clinical research,” says Harvard professor Dr. Christopher Cannon, executive director of Cardiometabolic Trials at the Harvard Clinical Research Institute.

Clues from cohort studies

Perhaps the most famous example is the Framingham Heart Study, which has yielded a wealth of information about the causes of heart disease and stroke (see www.framinghamheartstudy.org). So has the Multi-Ethnic Study of Atherosclerosis, which includes ethnically diverse people from six communities throughout the United States (see www.mesa-nhlbi.org).

Both are examples of cohort studies, which follow a large group of people over a long period of time. Through questionnaires or interviews, researchers gather information on a wide range of things—diet, exercise, and medical and family history, for example. They may also measure different variables (such as blood pressure or cholesterol level) or do other testing, such as a coronary artery calcium scan, which looks for early signs of heart disease.

Evaluating new therapies

A clinical trial is type of study in which volunteers receive a new treatment, which may be a medication, a procedure, or a device. Most often, volunteers are randomly assigned to receive either the investigational treatment or the comparison, which may be a placebo (an inactive therapy) or a treatment that’s already available.

“A key requirement for any study is to have clinical equipoise, which means we don’t know which of the two treatments is better, even though there may be known pluses and minuses for either approach,” says Dr. Cannon.

All clinical trials have very specific guidelines about who can participate. Some seek healthy participants, while others require people with a specific condition or illness. Researchers also use a variety of different criteria—including age, blood test results, and other medical conditions—to include or exclude people from a trial. This helps protect the participants’ safety and ensures the investigators get the information they need.

Anyone who volunteers for a research study must undergo a process known as informed consent, which is designed to help them clearly understand what to expect, as well as the risks and benefits of participating. An independent committee known as an Institutional Review Board ensures the study protects the rights and welfare of the participants.

In addition, the FDA reviews proposed studies of new drugs or devices and approves only those for which they deem the potential benefit is greater than the possible risk, Dr. Cannon explains. Still, there can be unforeseen side effects from any experimental treatment, and they can be unpleasant, serious, or even life-threatening. Another possible downside is the inconvenience, as the study may require extra clinic visits and complex treatment regimens.

On the other hand, the extra medical attention—which is in addition to your usual care—may be helpful, because any changes in your health are more likely to be noticed. Another potential advantage is access to new therapies before they are widely available or affordable. But in most clinical trials, you won’t know if you get the new treatment or not, notes Dr. Cannon.

For more information

If you’re considering joining a clinical trial, your doctor may be able to steer you to a study appropriate for your particular condition. The National Library of Medicine maintains a current list of publicly and privately supported clinical trials at www.clinicaltrials.gov where you can search by condition, location, and other criteria.

Before signing up for a study, carefully read the informed consent form and be sure to get answers to these questions:

  • Are there alternative treatments other than the one being tested in the trial?

  • How will you monitor my safety during the trial?

  • After the trial ends, can I opt to stay on (or switch to) the treatment being tested if it proves successful?

  • What happens if I am harmed by the trial?

Posted by: Dr.Health

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