Should I volunteer to be in a clinical research trial?

People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not exist presently. You may join a clinical trial hoping to get improved medical care.

For whatever reason, you may have questions about clinical trials and medical device research. The most important thing is to not be afraid to ask those questions. Your physicians and research coordinators can answer any questions you have before you choose whether or not to volunteer.

A clinical trial is a carefully designed study that is done with people like you who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Sponsor biotechnology companies have developed these drugs or devices, and then selected physicians – also called investigators – who are qualified to conduct clinical trials. It is through these clinical trials that investigational drugs and devices may show their benefits.

The clinical testing of an investigational drug or device is a step-by-step process that ensures you receive careful medical attention. Regulated clinical trials are reviewed by the U.S. Food and Drug Administration (FDA) and your hospital’s institutional review board (IRB). IRBs are independent committees whose job it is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks.

In a clinical trial, a volunteer is usually assigned to a specific group. Sometimes volunteers in one study group will receive or be treated with an investigational drug or device. Sometimes volunteers will receive or be treated with a control device. A control device is used to compare the results of the investigational treatment with a similar therapy, or with a placebo (a “dummy pill,” or a device that is not “turned on”). Whether you receive the control or investigational device, the level of medical attention and care that you receive is the same.

A detailed description of your specific clinical trial and what’s expected of you will be outlined in your consent form and reviewed with you by your physician or research coordinator.

Physicians and other healthcare professionals that conduct clinical trials are committed to providing you with quality patient care and medical attention. You should feel free to discuss your medical treatment with your investigator or any research staff member at any time during the course of your clinical trial.

Your safety is the number one priority in any clinical trial. Therefore, it’s important that you keep all of your scheduled visits and that you answer your investigator’s questions regarding how you feel.

Many study volunteers appreciate the medical attention that they receive when they participate. Your study investigator needs to record any symptoms you have – no matter how minor they may seem to you. Your input is valuable and important.

When you participate in a clinical trial, your privacy is protected. Your medical records are confidential. The trial data that is provided to the sponsoring company and the FDA will not include your name or the names of other participants.

After a study is complete, all of the information is collected and analyzed. Even after a drug or device is approved by the FDA for widespread use, sponsor companies may continue to conduct studies that compare the new drug or device in terms of its safety, effectiveness and cost to other treatments already on the market. In addition, some studies assess the treatment’s long-term effectiveness and its impact on the quality of a person’s life.

Every volunteer in a clinical trial is extremely valuable and important. Without volunteers, there would be no new drugs, devices or other treatments to fight diseases and ailments. By participating in a clinical trial, you are helping yourself and others like you to live longer and healthier lives now and long into the future.