Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility

Figures & data

Fig. 1 Dynamic Data Monitoring (DDM) system radar screen displays. Use the conditional power under the alternative hypothesis $0.05\le C{P}_a<0.90$ to define the hopeful (and other two) regions. The red dotted line is for $C{P}_a=0.5.$ Illustrations with data generated (the orange dotted line) when the true response rates are p₀, p₁, and $\overline{p}=\frac{p_0+p_1}{2}$, respectively, as indicated in the figure title.

Fig. 2 Dynamic Data Monitoring (DDM) system radar screen displays. Use the conditional power under the current trend $0.05\le C{P}_c<0.90$ to define the hopeful (and other two) regions. The red dotted line is for $C{P}_c=0.5.$ Illustrations with data generated (the orange dotted line) when the true response rates are $p_0,p_1,$ and $\overline{p}=\frac{p_0+p_1}{2}$, respectively, as indicated in the figure title.