What does East® do?

Successful clinical studies begin with the right trial design. East® 5 guides trial planners through the myriad of design options while offering more adaptive, group sequential and fixed-sample size clinical trial designs than any other commercial software package.

What sets East® apart?

With an ever increasing array of statistical methods, simulation and comparison tools, East® is the most widely used clinical trial design software system in use today. The optional modules - EastAdapt™, EastSurv™ and EastXact™ - further expand East’s capabilities.

Are the trial designs validated?
What is the regulatory perspective on East®?

All methodologies in East are fully referenced and all designs are highly validated. Hundreds of adaptive and conventional East-designed trials have been accepted and successfully implemented by biopharmaceuticals, device companies and research institutions worldwide.

East® is also currently in use at the FDA divisions of CDER, CBER and CDRH. Cytel experts periodically train FDA statisticians in East® use, and also advances in the statistics if adaptive and group sequential designs. East® is also referred to at the EMEA, MHRA and other European regulatory trial design overseers.

What’s new in East® 5

New additions to the industry's foremost trial design system include:

• Expanded visualization tools for better understanding of trial design concepts among 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
• More stopping boundary specifications options, including Lan-DeMets, Haybittle-Peto, Want Tsiatis and other published or user-specified error-spending functions

For a complete trial design and simulations index, download the East® brochure.

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 graphics 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 to 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:
3. • 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
• 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.