DAE

Abstract

Early phase clinical trials generate information on pharmacokinetic parameters and on safety issues. In addition, a dose level, or a set of dose levels, needs to be selected for further examination in later phases. If patients, rather than healthy volunteers, take part in the early phase, it may be possible to observe the effects of the drug on the disease. In the presentation we will discuss some statistical, ethical and economic aspects of designing optimum adaptive clinical trials for dose selection incorporating both pharmacokinetic and pharmacodynamic endpoints.