A scheme for a dose-escalation study when the event is lagged
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Updated: Oct 3, 2026

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction
Published on: January 29, 2019
J Hüsing1, W Sauerwein, K Hideghéty
1Institut für Medizinische Informatik, Biometrie und Epidemiologie, Medizinische Einrichtungen der Universität-Gesamthochschule Essen, Hufelandstrasse 55, D-45127 Essen, Germany. johannes.huesing@uni-essen.de
Abstract:
Classical designs for clinical phase I trials assume that information about a dose-limiting event (DLE) is available for all the included patients, or advise not to treat new patients until the information is present. If a DLE occurs after a lag, however, information at the current time might not be sufficient to make clear-cut decisions according to these designs. In particular, if new patients are available, it is not clear whether to include them in the trial. We suggest a rule that decides on the accrual of each individual eligible patient. Simulation studies are presented that indicate an advantage over the standard 'three-at-once' design in the length of the study.
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