How is a Drug Approved for Testing in Humans?
Following successful testing in the laboratory and in human cells, and in animal studies, a pharmaceutical company applies to the U.S. Food and Drug Administration (FDA) to test in humans. The FDA must authorize the company’s request before testing in human volunteers. Who Can Volunteer? Usually, people with the condition being studied can volunteer in a clinical trial. Sometimes healthy patients can participate as well. The FDA has strict guidelines for who can participate in a study. How do I know if I Qualify? Each clinical trial has specific requirements for age, sex and medical condition being studied. The physician conducting the study, called the Principal Investigator, (P.I.), will review your medical history and study requirements to determine your eligibility. When the doctor determines you are eligible to participate, the physician will explain the study to you during the informed consent process. What is Informed Consent? Once the doctor determines you qualify for a clinica
