1.5 Widespread Research on Adaptive Designs Since the Turn of the 21st Century

1.5.1 Early Phase Oncology Designs

For many oncology development programs, the first clinical trials in humans are in cancer patients with a primary objective to estimate the maximum tolerated dose (MTD). A review paper by Le Tourneau et al. provides an overview of dose escalation methods for phase I oncology trials [54]. A 3+3 design has traditionally been used and continues to be used to estimate the MTD by some sponsors. A 3+3 design tests 3 patients at a dose initially. If none of the 3 patients has what is referred to as a dose limiting toxicity (DLT), the next higher dose will be studied. If 2 or more out of 3 patients have a DLT, the dose is considered toxic ...

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