Robust Trial Design Under Treatment And Enrollment Uncertainty

By Esha Senchaudhuri

The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the selection of patient population, choice of endpoints, even recruitment uncertainties can assail the typical decision-maker. In a recent Cytel webinar, Dr. Pantelis Vlachos argued that with access to the right historical data, uncertainty can transform into robust clinical trial design. Using a Phase III double-blind multicenter trial, Dr. Vlachos showed how new technology can be harnessed to answer an array of questions about early stopping, the pacing of interim analyses, enrollment variability and cost-optimization.