Table 1

Summary of some key features of rule-based and model-based designs1

Rule-based designsModel-based designs
Target dose-limiting toxicity rateUnclearClearly defined and can be flexibly chosen
Patients treated at the optimal dose(Relatively) few(Relatively) many
Patients treated at subtherapeutic doses(Relatively) many(Relatively) few
Utilisation of available dataPoorEfficient
Extension to more complex questionsDifficult and dubiousSmooth and straightforward
Deviations from the plan (eg, other doses, different number of patients on a dose)Hard or impossible to incorporateEasily accommodated