ABSTRACT
Challenges in dose-finding studies were discussed in the previous chapters on MCP-Mod methodology and design of Phase II dose-finding studies. Problems related to design inefficiency in conventional Phase II studies were also examined in the first chapter with suggestions for more efficient dose allocations. However, the optimal dose allocation depends on the unknown dose–response relationship. Considering the dose allocation based on a guess of the true dose–response model may result in an inefficient design. Adaptive designs make use of accumulating information to safeguard against design misspecifications. The purpose of this chapter is to introduce and discuss adaptive two-stage dose-finding designs.
