Statistical issues for design and analysis of single-arm multi-stage phase II cancer clinical trials.

摘要: Abstract Background Phase II trials have been very widely conducted and published every year for cancer clinical research. In spite of the fast progress in design analysis methods, single-arm two-stage is still most popular phase trials. Because their small sample sizes, statistical methods based on large approximation are not appropriate Methods As a prospective research, method trial predetermined at stage it analyzed during end as planned by design. The should be matched with method. For single arm trials, Simon's has standards choosing an optimal design, but resulting data ignoring aspect sizes. Conclusions this article, we review that exactly get along exact We also discuss some to improve existing