New Additions to the Most Relied Upon Clinical Trial Design System

Trial Design

• Design multiple trials quickly through a point-and-click, Excel-based interface, and compare trial designs side-by-side
• Calculate sample size and stopping boundaries for superiority, futility and non-inferiority studies
• Choose stopping boundaries from the Wang-Tsiatis, Lan-Demets and Haybittle-Peto families, or derive stopping boundaries from a series of published error-spending functions

Interim Monitoring Module

• Simultaneously track the test statistic, re-computed stopping boundaries, error spent, conditional power and post-hoc power through a convenient dashboard-style user interface
• Calculate conditional power and repeated confidence intervals (Jennison and Turnbull, 2000) at each interim look. Calculate adjusted p-values, confidence intervals and point estimates at the end of the study
• Make informed decisions about trial outcome and stopping probabilities

Simulation

• Simulations allow statisticians, clinicians and regulators to understand the implications of different design possibilities so that the best design can be chosen
• Simulate studies to predict outcomes
• Verify a study's test statistic and power

Documentation and Regulatory Information

East® has an exceptionally comprehensive user manual with detailed examples, case studies and theoretical appendices. East’s online manual is indexed for context sensitive help.

East® 5 software complies with the ICH-E9 Guidance published by the FDA in Federal Register, Vol. 63, No. 179, pages 49583-49598, 1988. For more technical information, please contact info@cytel.com or call 617.661.2011.