Chances are you've seen one of these ads in your local newspaper or on television: "Do you suffer from (insert common medical condition here)? Would you like to participate in a research study to evaluate a new treatment?" Many people are curious about such studies but hesitate to take the next step.
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.
Types of studies
One of the most famous studies is the long-running Framingham Heart Study, which has yielded a wealth of information about the causes of heart disease and stroke. It's an example of a cohort study, which follows 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 to assess a person's health status.
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.
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 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.
Safeguards in place
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 is performed in a way that 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, although in any clinical trial, 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 condition. The National Library of Medicine maintains a current list of public 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?