“Clinical trials are approved and reviewed in phases,” says Kissela, who is also a UC Health physician. “Phase I studies assess the safety of a drug or device. Phase II studies assess the efficacy of a drug or device. Phase III studies involve randomized and blind testing in several hundreds to several thousands of patients to assess the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. Then FDA approval is sought followed by Phase IV studies, often called ‘post marketing surveillance trials,’ which are conducted after a drug or device has been approved for consumer sale. [It is] compared to other drugs on the market; [we] monitor its long-term effectiveness and impact on a patient’s quality of life and determine cost-effectiveness.”
“When hydroxychloroquine was given to patients initially, there was no placebo or sugar pill control group. And there was no randomization, meaning Group A received the medication and Group B received nothing, in order to compare outcomes,” adds Fichtenbaum. “Doctors were just trying to save lives. Now, we’re doing things right, assessing risks for a number of possible treatments, dosages and benefits, and we are tracking the data.”
UC is involved in about 1,000 active clinical studies across the academic health system at any given time, Kissela says, noting that it is more than equipped to take on these COVID-19 studies.