Who Approves a Clinical Trial?
Before beginning a clinical trial on human subjects, it must be reviewed by and approved by the FDA and an Institutional Review Board (IRB). The FDA reviews the known information about the drug and the proposed plan for the clinical trial. An IRB is an ethics committee that reviews the trial making sure that the patient’s rights and safety are protected and that the trial is scientifically sound. The trial itself is conducted by qualified doctors and other healthcare professionals.
Can I participate in a clinical trial?
If you meet certain criteria, you may qualify to volunteer for a clinical trial. This evaluation usually includes a review of your history and medical records, a physical exam, and bloodwork. It may also include additional studies such as a sonogram, x-ray, and EKG. All of these will be done at no cost to you and you will be compensated for your time and travel.
If I participate in a trial, what can I expect? How long will it last?
Depending on the medication or device being evaluated, different trials will last different periods of time. For example, a trial may only require one visit. Others may last several months to a few years and require regular visits such as on a monthly or quarterly basis.