A scheme for a dose-escalation study when the event is lagged.
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.
Hüsing
J
J
Institut für Medizinische Informatik, Biometrie und Epidemiologie, Medizinische Einrichtungen der Universität-Gesamthochschule Essen, Hufelandstrasse 55, D-45127 Essen, Germany. johannes.huesing@uni-essen.de
Sauerwein
W
W
Hideghéty
K
K
Jöckel
K H
KH
D016754:Boron Neutron Capture Therapy / Q000009:adverse effects; D001932:Brain Neoplasms / Q000532:radiotherapy; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D003198:Computer Simulation; D004305:Dose-Response Relationship, Drug; D006801:Humans; D020714:Maximum Tolerated Dose; D018579:Patient Selection