Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data.

Hassing GJ, van Esdonk MJ, van Westen GJP, Cohen AF, Burggraaf J, Gal P

During phase I study conduct, blinded data are reviewed to predict the safety of increasing the dose level. The aim of the present study was to describe the probability that effects are observed in blinded evaluations of data in a simulated phase I study design.