Statistical Innovations in Vaccine Development

• Activity Number: 269
• Type: Invited
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Ivan S.F. Chan*+ and Joseph Heyse
• Companies: Merck and Merck
• Keywords: Adaptive design ; trial monitoring ; correlate of protection ; Vaccine

Abstract

Vaccines have a long history of providing protection to human health. As an example, eradication of a deadly disease, Smallpox, was accomplished in 1980 via massive vaccination programs around the world. In fact, vaccination was recognized as the greatest public health achievement of the 20th century by the Center for Disease Control and Prevention. In recent years, statisticians have been playing an increasingly important role as collaborative researchers in vaccine development. In this talk, we will highlight some innovative applications of statistical techniques that contribute to the successful development of several vaccines for prevention of diseases such as chickenpox, herpes zoster, rotavirus gastroenteritis, and cervical cancer. Real life examples will be used to illustrate statistical innovations in several areas, including trial design and adaptation, safety monitoring, endpoint measure, and evaluation of correlate of protection. These statistical innovations are a reflection of statisticians' engagement and leadership, which has resulted in a substantial improvement of the scientific rigor, quality, and operational efficiency in vaccine development.