JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.


Back to main JSM 2007 Program page

Abstract - #309074
Title: On Group Sequential Adaptations in Vaccine Development
Author(s): Ivan Chan*+ and William Wang and Joseph Heyse+
Companies:
Address: 351 North Sumneytown Pike, North Wales, PA, 19454, 351 North Sumneytown Pike, North Wales, PA, 19454,
Keywords: Vaccine Trials ; Group Sequential Adaptation
Abstract:

The application of adaptive designs has recently been studied and intensely debated in the development of drug products. In this talk, we will point out that group sequential adaptations could readily be applied to vaccine development due to many unique features. These features include (1) relatively short risk period in vaccine safety evaluation (2) convenient immune marker in vaccine immunogenicity trials, and (3) long-term follow-up in vaccine efficacy trials. We further discuss sample size re-estimation, alpha spending strategy, adjusted group sequential estimation, and two-stage mid-course adaptation in the context of vaccine development. We will use two recently completed pivotal vaccine trials, the Shingles Prevention Trial (Oxman et al., NEJM 2005) and the Rotavirus Efficacy and Safety Trial (REST) (Vesikari et al, NEJM 2006), along with simulations to illustrate our points.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

Back to the full JSM 2007 program

JSM 2007 For information, contact jsm@amstat.org or phone (888) 231-3473. If you have questions about the Continuing Education program, please contact the Education Department.
Revised September, 2007