East® Xact
Exact Statistical Design and Simulation Tools for Clinical Trial Planners

East® Xact is a suite of trial design options for Cytel’s East® applicable to clinical studies with binomial endpoints with small sample sizes or proportions that are close to zero.

What does East® Xact do?

East® Xact provides clinical trial planners with statistical design and simulation tools utilizing exact binomial distributions. East® Xact is an optional module for extending the capabilities of the East® clinical trial design software system.

Why is it important?

In small sample sizes or with very high/low proportions, asymptotic normal approximations may lead to inaccurate power calculations. Instead, East® Xact utilizes statistical methods based on exact binomial distributions which are more precise than asymptotic normal approximations especially in calculating trial power.

For whom is East® Xact intended?

Any statistician designing a clinical trial with a binomial endpoint, particularly in studies with small sample sizes or very high/low event rates.

What therapeutic areas does East® Xact best suit?

Beneficial to most if not all therapeutic areas, but especially in trials for oncology, infectious diseases and vaccines.

Key benefits

• Better protection of the design’s type 1 error in trials involving small sample sizes or very high/low event rate employing exact binomial distribution statistical methods
• Greater accuracy in determining the power of the design
• Added ability to design studies consistently with the planned inference

Key features

• Exact fixed sample design, IM, simulation for one- and two- sample binomial tests
• Exact group sequential design, IM, simulation for one-sample binomial
• Simon’s 2-stage design for one-sample efficacy screening

Contact us for more information on the specific capabilities of East® Xact, along with license and training options.