When people take a prescribed drug, they rarely if ever consider how it came to be. They assume it is the right drug and will work safely as it is supposed to. But leading up to that drug being available is a long process of discovery or invention of the molecule based on knowledge of the biology it is supposed to affect, then testing in the laboratory and in animals, and several phases of testing in people to make sure that it is safe and effective. Each of these steps takes time and lots of financial investment. Even after a drug is approved by the U.S. Food and Drug Administration for sale and then put on the market, further study of the drug in a larger population than in the testing phases may be carried out. In this episode, Dr. Hubert Fernandez, Director of the Center for Neurological Restoration at the Cleveland Clinic in Ohio, a Parkinson’s Foundation Center of Excellence, describes the process of bringing a drug to market, including how many of them never make it. And he explains why people need to participate in the clinical trials and what they can expect when they do.
Related Resources
- Understanding Parkinson’s: Clinical Trials
- Episode 34: New Pathways & Drug Development (podcast)
- Episode 59: Understanding Biomarkers to Deliver Precise Treatments (podcast)
- Episode 60: What is a Disease Modifying Therapy in PD? (podcast)
- About Parkinson's Advocates in Research (PAIR) Program
About This Episode
Released: August 25, 2020
Hubert Fernandez, MD
Hubert H. Fernandez, MD, is Professor of Medicine (Neurology) at the Cleveland Clinic Lerner College of Medicine, Case Western Reserve University and the Head of Movement Disorders under the Center for Neurological Restoration at Cleveland Clinic in Cleveland, Ohio.
Dr Fernandez received both his BS in Biology and MD degree in the Philippines. He completed his internship in internal medicine at University of Pennsylvania/Pennsylvania Hospital in Philadelphia, Pennsylvania; his residency in neurology at Boston University Medical Center in Massachusetts; and his fellowship in movement disorders at Brown University in Rhode Island.
Dr. Fernandez is an internationally recognized expert in movement disorders who has been voted one of the Best Doctors in America by his peers. After completing his medical training, he joined the faculty of Brown University School of Medicine as Assistant Professor of the Department of Clinical Neurosciences and served as Associate Director of the Movement Disorders Unit and Neurological Director of its Functional Neurosurgical Program. In 2003, Dr Fernandez relocated to the University of Florida, where he eventually became Director of the Clinical Research Unit for Neurological and Psychiatric Disorders, Vice Chair of Academic Affairs, and Professor of Neurology prior to joining Cleveland Clinic. An active and productive researcher, he has initiated or participated in over 50 clinical trials and has published his findings in well over 300 articles and abstracts on Parkinson’s disease, cervical dystonia, blepharospasm, and other movement disorders. He has nearly 40 published book chapters and books to his credit, and has served on the editorial board of Movement Disorders and is currently an editorial board member of the American Journal of Clinical Neurology, European Neurological Journal, and Clinical Neuropharmacology.
Dr Fernandez is a fellow of the American Academy of Neurology, and a member of the American Neurological Association. He is currently elected as a Councilor for the AAN Movement Disorders Section, Executive Committee Member of the Parkinson Study Group and Dystonia Study Group; and is also an Executive Board Member of the World Neurology Foundation. He has served as President of the Florida Society of Neurology, and is the current Co-Medical Editor of the Movement Disorders Society Web site. Recently, he has been elected the Co-Chair of the Parkinson Study Group for a 6 year term.
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This episode is supported by a grant from Genentech, a member of the Roche Group.
For more insights on this topic, listen to our podcast episodes “Retention Rates in Longer Clinical Studies” and “Repurposing Medications to Slow Progression of PD.”
