Clinical Trials Director's Comments
Richard Rupp, MD
The Clinical Trials Group performs the human trials for the Sealy Center for Vaccine Development. Clinical trials are the final step in the vaccine development process, providing the necessary data on vaccine efficacy, immunogenicity and safety in humans. Our investigators and coordinators are experienced with all phases of vaccine trials from first-in-human phase I studies through phase IV postmarketing studies. Additionally, our team works with investigational drugs and biologics against infectious diseases in the neonatal nursery and hospital. We have proven success with study populations spanning the lifespan from premature infants to the elderly. Our utmost concern is the safety of our volunteers.
The Clinical Trials Group handles a mix of industry and NIH-funded projects. We provide administrative oversight, including IRB submission and reporting, facilitation of budget and contract negotiations, management of regulatory documentation, and comprehensive operational support. Our team utilizes an on-site laboratory to manage sample processing and shipping. The physicians, coordinators and research assistants are all trained in Good Clinical Practice (GCP). The Clinical Trials Group is frequently commended by its sponsors for swift study setup, exceeding recruitment goals, high retention rates and quality data.