Learning from previous responses in phase I dose-escalation studies

Dose escalation in phase I studies is generally performed on the basis of c linical experience and judgement. In this paper some of the statistical app roaches that have been proposed for the formalization of the procedure are described. Apart from the use of the Continual Reassessment Method in oncol ogy studies, such formal methods have received little implementation. The p urpose of presenting them here is to promote their further exploration and appropriate implementation. Certain limitations are discussed, which will b e best overcome by collaboration between clinical pharmacologists and stati sticians.