Should your patient volunteer to be in a clinical research trial?

People volunteer to participate in a clinical trial for a number of reasons. They may get involved simply want to help in the advancement of science. Or they may be suffer from a disease for which a good treatment does not presently exist.

Many physicians and patients have questions about clinical trials and medical device research. The most important thing is to not be afraid to ask those questions. Iowa Heart physicians and research coordinators can answer any questions you have before the patient chooses whether or not to volunteer.

A clinical trial is a carefully designed study that is done with people who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Sponsor 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.

Regulated clinical trials are reviewed by the FDA and a city-wide institutional review board (IRB). The IRB is an independent committee whose job it is to make sure patient rights are fully protected, and that patients are not exposed to 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. Other volunteers may receive or be treated with a control device, standard therapy or placebo. Patients receive the same level of medical attention and care regardless of the group to which they are assigned.

Iowa Heart physicians and research professionals are committed to providing quality patient care and medical attention. Patients should feel free to discuss their treatment with an investigator or research staff member at any time during the course of the trial.

Safety is the number one priority in any trial. Therefore, it’s important that patients keep all of their scheduled visits and answer the investigator’s questions.

Privacy is protected for participants in clinical trials. Medical records are confidential. The trial data provided to the sponsoring company and FDA does not include the names of participants.