The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Adaptive Designs for Infectious Diseases Clinical Development Strategy

December 11, 2014

 

A common framework for the clinical development of vaccines involves the study of several candidate compounds in Phase 1 followed by the selection of potential vaccine regimens for study in Phase 2 and Phase 3. In the attached presentation, Cytel Consulting’s Jim Bolognese compares traditional and adaptive Phase 1/Phase 2 studies for vaccines and infectious diseases, providing simulations results for both 2-stage and multi-stage adaptive designs. Jim also outlines a structure for a Hybrid Adaptive Study.

Read More