Learning from previous responses in phase I dose-escalation studies.
Dose escalation in phase I studies is generally performed on the basis of clinical experience and judgement. In this paper some of the statistical approaches that have been proposed for the formalization of the procedure are described. Apart from the use of the Continual Reassessment Method in oncology studies, such formal methods have received little implementation. The purpose of presenting them here is to promote their further exploration and appropriate implementation. Certain limitations are discussed, which will be best overcome by collaboration between clinical pharmacologists and statisticians.
Whitehead
J
J
Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN. j.r.whitehead@reading.ac.uk
Zhou
Y
Y
Stallard
N
N
Todd
S
S
Whitehead
A
A
D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
D000970:Antineoplastic Agents