HIGHLIGHTS
SUMMARY
Efforts to develop biomarker-targeted anti-cancer therapies have progressed rapidly in recent years. The pooled control arm design enrolled a total of 113.2 patients under the null and 159.6 under the alternative, out of a maximum of 200. The enrichment design requires testing the largest number of patients, with 450 patients requiring PD-L1 testing if the design proceeds to stage 2, whereas the pooled design only tests 150 patients and the stratified design tests 300 patients. While the authors have developed open-source R software for the design of single . . .
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