What is a clinical trial?

A clinical trial is a drug study sponsored by a pharmaceutical or biotechnology company. The purpose of these studies is to find out whether a medication is safe to use and effective against various diseases or medical conditions. Qualified physicians and other research professionals supervise clinical trials that are approved by the U.S. government’s FDA as well as Institutional Review Boards.

In a clinical drug trial a volunteer is randomly assigned to receive either an investigational medication, a medication already commercially available, or a placebo. Throughout the study the volunteer returns for regular check-ups to make sure that the treatment is safe and effective.

Why are clinical trials important?

Clinical trials facilitate the development of new and alternative drug treatments. These drugs, in turn, may present an alternative course of treatment for a patient. These trials assist drug manufacturers in making informed decisions about whether to pursue bringing a new technology to the marketplace. Ultimately, these trials continue to assist the industry’s efforts at developing medications that are safer, easier to administer, and more effective.

Why should I join?

By volunteering in a clinical trial, you may help in the development of new medical therapies that may offer better treatment, or even cures, for life-threatening or chronic diseases. People participate in clinical trials for various reasons: to help in the advancement of science, to get medical care, or in hopes of trying the latest treatment for a particular disease or condition.
It is important that you make an informed choice about volunteering for a clinical trial. Before signing an informed consent form, you must read it, understand it, and ask pertinent questions about the protocol. You always have the right, for any reason, to withdraw your consent and remove yourself from the study.

Trial Procedures
After enrolling, you will receive a physical examination, a review of your medical history and a detailed description of the clinical trial. Your responsibilities and expectations will be discussed. It is important that you feel comfortable with the role you will be playing as a clinical trial participant. You should feel free to discuss your medical treatment with your primary physician or provider at any time.

What happens after a study is complete?

After the study is done, a patient will return to their regular medical care. All information from the trial is collected and analyzed. Sometimes, an extension to the study is provided so a patient can continue on their current course of therapy. FDA medical advisors and specialists review the information before approving any new drug or device.