Q. What is a clinical trial?

A clinical trial is the term given to the testing, for safety and effectiveness, of drugs or devices in people. Only drugs and devices that show promise in the laboratory and have passed rigorous safety testing in animals obtain approval to be tested in people.
 

Q. What happens during a clinical trial?

With your permission, questions are asked to see if you qualify for a particular trial. If so, you are asked to give your consent to participate after reading an informed consent form and having an opportunity to discuss it with your doctor or whomever you like. At scheduled visits you will see the different members of the study team of doctors, study coordinators, nurses, and other medical personnel. You may have physical exams, lab or other diagnostic tests, be asked to fill out questionnaires, and be given study medication.
 

Q. What is informed consent?
Informed consent is the process whereby a research patient becomes fully informed about the proposed research trial. It begins with a discussion with the study team and proceeds with a written document for you to review and sign that details the purpose of the research, the length of the trial, the procedures involved, the risks and benefits, where the research will take place, and what financial compensation may be available.
 

Q. How is my safety protected?

There are potential risks in taking any drug and that is why your safety is the number one concern during your participation in a clinical trial. Regular physical exams, safety lab tests, and other tests are performed and your study coordinator remains in constant contact with you. You may withdraw at any time for any reason and that will not affect your regular medical care.

Please visit http://clinicaltrials.gov/ct2/info/understand for a comprehensive list of frequently asked questions.