New additions to the world's most relied upon 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 dash-board 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 Features

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

ast 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.