EastXact™ is a suite of design options for Cytel’s East® and specifically applicable to clinical trials with binomial endpoints with small sample sizes, or proportions that are close to zero.

What does EastXact™ do?

EastXact™ provides clinical trial planners with statistical design and simulation tools utilizing exact binomial distributions. Joining EastAdapt™ and EastSurv™, EastXact™ is our most recently introduced optional module for extending the capabilities of Cytel’s 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, EastXact utilizes statistical methods based on exact binomial distributions, which are more precise than asymptotic normal approximations especially in calculating the power of a trial.

For whom is EastXact™ designed?

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 benefit?

Most if not all therapeutic areas are applicable, 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

Please contact us for more information on the specific capabilities of EastXact, along with license and training options.