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We develop three approaches to phase I dose finding designs for engineered T cells in oncology. Our goal is to address a very particular difficulty in this clinical setting: an inability to fully administer the dose allocated to some patients. Current designs can be biased as a result of this incomplete information being ignored or discarded from the analysis. The performance of the three proposed...
We consider a comparison of Kaplan–Meier curves from clinical trials in which there may be a delayed treatment effect. Any such delay takes us outside the umbrella of a proportional hazards structure and therefore outside the setting in which the log‐rank test would be optimal. The approach of Chauvel and O’Quigley based on Brownian motion approximations enables the construction of powerful tests...
The continual reassessment method (CRM) was first introduced by O’Quigley et al. [1990. Continual reassessment method: a practical design for Phase I clinical trials in cancer. Biometrics 46, 33–48]. Many articles followed adding to the original ideas, among which are articles by Babb et al. [1998. Cancer Phase I clinical trials: efficient dose escalation with overdose control. Statist. Med. 17, 1103–1120],...
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