What is a clinical trial?
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.
Pharmaceutical and biotechnology companies have developed these treatments. Physicians, also called investigators, who are qualified to conduct clinical trials are selected to conduct the study. It is through these trials that we may discover the benefits of the investigational drug.
All medications currently available by prescription have been approved through the clinical trial process by the U.S. government’s Food and Drug Administration (FDA) to establish safety and effectiveness for treating a particular disease.
Is it safe to participate in a clinical trial?
Yes. Your safety is always paramount.
It is our job to keep you well informed of all potential risks involved with participating in a clinical trial. We closely monitor your health by routine measurement of vital signs and laboratory results throughout the trial in addition to regular office visits and phone calls to keep your safety at the forefront. As with all medications, there can be side effects but through this collaborative effort between patient and doctor, we can mitigate the risks involved when testing new medications.
As a participant, it is important that you take all your medication as prescribed, that you keep all your scheduled visits, and that you answer your investigators questions regarding how you feel and whether you’ve been taking your medication at scheduled times.
What is a placebo?
A placebo is an inactive product used to compare the results of the study drug. You, your physician and your research staff may not know who is receiving a placebo and who is not. In this way, volunteers in a clinical trial can be observed by the physician and research staff more fairly. Where you receive the placebo or the investigational drug, the level of medical attention and care you receive is the same.
Not all clinical trials will have a placebo group. These are often referred to as “open-label” trials and every participant will receive the investigational drug.
What can I expect if I agree to participate in a drug trial?
You will be asked to sign a consent form which outlines the study, your risks, rights, and what you can expect from the experimental drug. You must sign the consent form before any procedures can be completed. You can then expect a physical examination, medical history, family history and a variety of screening test to determine whether you qualify for the drug trial. If you qualify, the drug trial will begin.
What if I don’t like how the study medication makes me feel?
As with any medication you must decide whether the benefits outweigh the side effects. You can exit a clinical drug trial any time you choose.