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Statistics Seminar Series

Thursday, November 30, 2006 @ 4:00PM
Campus Center, Room #220
New Jersey Institute of Technology

Adaptive Design in Antibiotic Trials

  Gang Li, Ph.D.
Director of Biostatistics
Johnson & Johnson PRD

Adaptive design is expected to reduce the risk of antibiotic trials by using the interim data to examine the assumptions on cure rate and evaluability rate that are used for the sample size calculation.  In application of adaptive design, one of the challenges is back-calculation, i.e., by knowing the overall cure rate and the second stage sample size, the first stage treatment effect may be accurately calculated, which causes a concern of operational bias.  Some practical issues will be discussed as well.