Nov 6, 2019
Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND).
In this episode, Therese Markow and Dr. Robert Temple discuss what the term clinical trial means and how it compares to clinical studies or clinical investigations, as well as the many various facets of applying for and conducting a clinical trial. All clinical trials must be approved through the FDA application process and, once completed, the results must be reported back to the FDA. As new drugs and other therapies have been developed clinical trials became more relevant throughout the 20th century. They discuss how a positive outcome of a clinical trial is determined, namely that there is an improvement in the particular condition being targeted and that there are no harmful effects.
"That’s what I hope will be conveyed to people – you should be in trials because it’s good for everybody, we learn more." — Dr. Robert Temple
Connect with Dr. Robert Temple:
FDA Bio: Robert Temple M.D.
Connect with Therese:
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