Clinical Trials from A to Z - Risks and Benefits

Risks and Safety Measures
Participants must be aware that they may experience unpleasant, serious, or even life-threatening side effects of the drug or treatment being studied. They must also know that the treatment may not work, and that the requirements of the study may be more than they bargained for. Every clinical trial has a protocol, which is the plan on which the entire study is based. The protocol describes exactly what the participants must do during the trial such as how often they need to see the research staff, how much of the drug they need to take, what other procedures they must follow, and how long the trial will last. Sometimes, particularly for participants who are not in good health, these activities take up a good deal of time and attention.

To minimize risks, all clinical trials that involve human participants in the United States are approved and monitored by an Institutional Review Board (IRB). This is a group of doctors, researchers, community advocates, and others who ensure the ethical nature of the trial and make sure that the rights of the study participants are protected. The IRB also reviews all study-related documents such as the protocol, participant recruitment announcements, and consent forms.

Benefits
There are also many benefits to participating in a clinical trial. Not only does it give patients access to the latest research and treatments before they are available to anyone else, patients often are able to get expert medical care from leading health centers during the trial. Participation in a clinical trial also allows patients to become active participants in their own health care as well as help others by contributing to medical research. For many people, these benefits outweigh the potential risks of participation.

Clinical Trials: It's Your Choice
It's your personal choice if you want to participate in a clinical trial. If you are unsure, talk to your doctor, family, and friends. If you find a trial that you might qualify for, contact the research staff to get more information. Knowing as much as you can about the trial will make your decision a bit easier.