Breaking down the phases of FDA clinical studies

An 8-year-old boy living in a town outside Glasgow, Scotland, experienced a frightening bacterial meningitis epidemic in which five of his best friends died, one of his friends lost his hearing in both ears, and the young boy lost his sight completely in one eye and partially in the second eye. This young boy was why I became an ophthalmologist and why I continually participate in clinical trials to find new ways to improve care for our patients both medically and surgically. This young boy was my father, who in the 1940s persevered to become a well-established attorney and judge before Parkinson’s disease took his life.

Mitchell A. Jackson

Although I became an anterior segment surgeon and do not treat optic neuropathies on a daily basis, my obligation to my patients and my field is to participate in clinical studies to help discover new therapies. Each and every surgeon will most likely have the opportunity at some point in his or her career to participate in clinical study, but weaving through the maze of clinical research can be a bit daunting at first glance.

There are many phases of clinical research as defined by the U.S. Food and Drug Administration: preclinical and phases 0, 1, 2, 3 4 and 5. These phases apply to both pharmaceutical drugs and surgical devices, with the latter also having the well-known 510(k) approval.

Click here to read the full September 10 publication exclusive, The Premium Channel, by Mitchell A. Jackson, MD.