The multi-step process of developing a new epilepsy drug can take many years and requires a small army of researchers, chemists, scientists, physicians, and data analysts. But ultimately it’s the human volunteers and their responses to the drug that will determine if a new medication wins FDA approval. Clinical trials are the first time that the drug being evaluated is given to human volunteers. They are conducted in multiple phases and focus on safety, effectiveness, and potential side effects. Each phase of the clinical trial is carefully designed and rigorously regulated by the FDA to ensure the well-being of the volunteers and the collection of unbiased data by researchers. It’s a thoughtful and thorough process that holds the promise of transforming the lives of those with epilepsy.
In the second part of our 4-part series exploring the drug development process and clinical trial participation, we speak with Dr. Kelly Knupp, Associate Research Director of the Neuroscience Institute and Director of the Dravet Program at Children’s Hospital Colorado. Dr. Knupp provides a comprehensive explanation of human clinical trials in layman’s terms. She details the procedures and goals of each phase of the process, explains trial terminology, outlines key personnel and responsibilities, and describes the FDA requirements for new drug approval. It’s everything you want to know about clinical trials but didn’t know how to ask.
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