Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) talks about the safety of clinical trials.
As Dr. Marks makes it clear, clinical trials are monitored but numerous regulatory bodies, including the FDA to always ensure the safety of the trial participants is the top priority.
Dr. Marks noted there is always a risk of an adverse event or side effect with any treatment but he noted that the FDA, as well as the clinical trial managers, are constantly monitoring for safety so that the presence of any adverse events can be quickly adhered to.
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