East® Version 5

New EastXact Module Now Available
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Better plan even the most complex trials with more clinical trial design, simulation and analysis tools

Successful clinical outcomes begin with the right trial design. With more adaptive, group sequential and fixed-sample size clinical trial designs than any other commercial software package, East® 5 delivers a host of new features to better guide trial planners through the myriad of design options. 

New additions to the world's most relied upon trial design system include:

• expanded visualization tools for better understanding of trial design concepts amongst trial planners, clinical operations and regulators
• new report-ready tables for protocol review and study results submission
• better designs for trials using smaller sample sizes
• more single-look trial designs and simulations

From Cyrus Mehta, Cytel President, Co-Founder:

“East 5 builds on East’s reputation for versatility and accuracy. Many of the new features in East 5 came from ideas provided by our users, for example better ways to share trial concepts amongst non-statisticians like "Split Screen" and displaying of multiple graphis to compare results. Helping our customers confidently determine the best design and clearly communicate the design's concepts is what East 5 is all about.”

Optional modules extend East's core capabilities:

EastAdapt® Should the trial design be adaptive or group sequential? How many patients, how much time and what resources could be saved with an adaptive design? With EastAdapt®, design, monitor and simulate adaptive designs with methods that preserve type-1 error: 1. Using the inverse normal weighted combination of p-values re-estimate the sample size based on conditional power* 2. By preserving the conditional type-1 error, re-design on-going trials by changing design parameters** including: sample size spending function number of interim looks and interim spacing *Cui, Hung and Wang, Biometrics, vol. 55, pages 853-857, 1999. **Muller and Schafer, Biometrics, vol. 57, pages 886-891, 2001.		EastSurv® East's survival studies module provides the power to simulate and assess time-to-event designs. Using EastSurv trial designers can easily account for: subject drop outs non-uniform accrual non-constant hazard rates …and fixed follow-up time in studies with time-to-event endpoints EastSurv's survival trial simulations accurately estimate the total study duration - even under different enrollment patterns with differential drop out and varying hazard rates for the treatment arms. EastSurv accommodates both proportional and non-proportional hazards alternatives.

Recently introduced to East...

23 New Trial Designs
One-Sample, Two-Sample, K-Sample, and Regression Models

9 New Normal End Point Designs
One Sample, Regression, Repeated Measure, Equivalence,
and Crossover

12 New Binomial End Point Designs

• Superiority Trials
  One Binomial, McNemar, Ratio of Proportions, Odds Ratio of Proportions, Common Odds Ratio of Stratified 2x2 Tales, Equivalence of Proportions, Trend Test, Logistic Regression and Equivalence


• Generalized Non-inferiority Trials
  Non-inferiority tests for Difference of Proportions, Ratio of Proportions and Odds Ratio of Proportions powered at alternatives other than equality of the two treatments

Survival End Point Design
Cox proportional hazard model to handle covariates

Nonparametric Design
Wilcoxon rank-sum test

Asymmetric Two-Sided Stopping Boundaries
Provides additional flexibility when simultaneously testing for efficacy and safety

Confidence Interval Charts
Now select sample size based on the desired width of the confidence interval