Seminar
Ying Lu
"Research Questions in Statistical Design for Phase II Cancer Clinical Trials"
The primary objective of phase II cancer clinical trials is to determine
whether a new regimen has sufficient activity to warrant further study.
These trials are often single arm and compare to historical efficacy endpoints.
Simon's two stage design is the conventional approach. In this talk,
I will briefly review the Simon's two-stage design. I will then discuss statistical
questions for alternative designs under the 2-stage design framework,
including design for multiple endpoints, consistent estimation for efficacy endpoints,
adaptive design for endpoints, and characterization of endpoint markers useful
in two-stage design phase II trials.
