If you find yourself in a situation where current health treatment options are unsatisfactory, you may want to enroll in a clinical trial that is testing an experimental therapy.
A clinical trial evaluates whether new medical, surgical, or complementary treatments are safe, and how well they work in people (having already been tested in lab animals). Most of the medical advances in recent decades were first evaluated in clinical trials—and millions of Americans have taken part in these vital research studies.
To ensure participants of the highest level of safety, clinical trials must be approved and monitored by an institutional review board (IRB), an independent committee composed of doctors, researchers, and patient advocates. IRBs also ensure ethical practices. Participants must be well informed about their rights, including the right to withdraw at any time. Rules are strict. IRBs stop studies if side effects are common or dangerous.
The IRB also can halt a study if a treatment proves so beneficial that it should be made available to the control group—and the public—as soon as possible.
Participating in a clinical trial can have advantages and disadvantages, so ask questions at every step of the process. Your doctor is the best place to start. He or she will be familiar with any large trials you might benefit from participating in. Ask your doctor to explain the pros and cons of being treated in a particular trial.
People have diverse motives for wanting to take part in a clinical trial. Many, of course, want to see if a novel therapy will improve their health, and joining a study is the only way to gain access to this treatment. If they’re very lucky, the drug they’re given might be a “hot” new therapy that works. Altruism—hoping to help other people by participating in ongoing research—is another motivation for joining a trial. By enabling researchers to understand whether and how a therapy works in people, trial subjects are providing a priceless, irreplaceable gift.
Patients in a clinical trial are typically provided a lot of support and education. They are educated about their disease and helped with planning for the future and day-to-day management of symptoms. A benefit for both doctors and patients is the increased opportunity to talk one-on-one: Doctors come to understand patients and their disease much better than they could in a busy office setting.
Your participation in a clinical trial doesn’t start until you or a family member has signed the informed consent form. The study coordinator will explain each section to you; if you don’t understand something, ask questions until you’re satisfied that you know exactly what to expect and what will be required of you.
Feel free to take the consent form home so that you can review it with your personal doctor and your family before signing. Seriously consider the commitment you’re about to make. Although you can withdraw from a trial at any time, for any reason, a high number of withdrawals may affect the integrity of the study and weaken its results. When you sign the consent form, you are signing an agreement based on trust between you and the researchers.
To find a clinical trial, contact your local hospital or medical center, or ask your doctor to help. Be wary of claims in advertisements, and make sure your health costs are covered.
Other sources of information about clinical trials include:
• The National Institutes of Health, 800-411-1222.
• Center Watch, 800-765-9647.
• Trials Central