Phase I cancer trials increasingly incorporate dose‐expansion cohorts (DECs), reflecting a growing demand to acquire more information about investigational drugs. Protocols commonly fail to provide a sample‐size justification or analysis… Click to show full abstract
Phase I cancer trials increasingly incorporate dose‐expansion cohorts (DECs), reflecting a growing demand to acquire more information about investigational drugs. Protocols commonly fail to provide a sample‐size justification or analysis plan for the DEC. In this study, we develop a statistical framework for the design of DECs.
               
Click one of the above tabs to view related content.