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 currently exist. You may join a trial hoping to improve the medical care you receive or to learn more about your current condition. Lastly, if you do not have health insurance, clinical trials are a way to receive study-related medical care. A survey (MetaOps Sept. 2009) was conducted recently asking past study participants at Quest Research Institute for the most notable benefit they experienced. Here’s a sample response: “Finding a physician with education and awareness of my disease…finding a treatment that actually worked!”
A clinical trial is a carefully designed study that involves people like you who volunteer to receive investigational treatments under the close supervision of a physician and other research professionals. Pharmaceutical, academic and biotechnological companies have developed these treatments. These companies select physicians, called investigators, who are qualified to conduct clinical trials. It is through these trials that investigational drugs may show their benefits. Every medicine must show through clinical trials, that they are safe and effective prior to becoming available to the public.
Once you have enrolled in a study, you will receive an Informed Consent document which provides a detailed description of your specific clinical study and what’s expected of you. Your study physician or a research staff member will review your medical history and may give you a physical examination. You will have time to read the Informed Consent and ask questions of a medical professional to ensure you understand what will happen during the study.
No, joining a study does not require insurance or a physician referral. Participants will receive study medications at no cost and, in most instances, financial compensation for their time and travel.
The patient’s rights and safety are protected in two important ways. First, any physician awarded a research study must obtain approval to conduct the study from an Institutional Review Board or ethics committee. The board, usually composed of physicians and lay people, is charged with examining the study’s design to ensure patient’s rights are protected and that the study does not present an undue or unnecessary risk to people participating. Second, every participant must be presented with an Informed Consent form detailing the nature of the study. The consent form tells patients that they have the right to leave a study at any time.
Also see Questions to Ask prepared by The Center for Information & Study on Clinical Research Participation.