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William B. Smith

William B. Smith

MD, FACC, (VRG and NOCCR)

Title: Investigator Prospective on Vaccine Studies Protocol Development and Execution

Biography

William B. Smith, MD, FACC, is currently a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. He is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care Medicine. Dr Smith is the President of New Orleans Center for Clinical Research and Volunteer Research Group located within the University of Tennessee Medical Center. Dr Smith has been involved as a Principal Investigator in over 1800 clinical research studies to include first-in-man, cardiac disease, renal/hepatic disease, healthy volunteers, diabetes, numerous vaccines, women’s health, HSDD, obesity, Parkinsons, Alzheimers, Multiple Sclerosis, and smoking cessation.

Abstract

The issues for investigators and for sites are somewhat unique for vaccine studies. The large number of subjects enrolled in a very short time, the number of minor AEs, the large total number and different types of specimens to process and the need for 1-5 year subject retention. This session will discuss these differences and offer practical considerations to assist with protocol development and execution.