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EastXact®

EastXact™ is a new 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?
The new EastXact® is an optional “module” that extends the capabilities of Cytel’s East clinical trial design software system.  EastXact® provides clinical trial planners with statistical design and simulation tools utilizing exact binomial distributions.

Why is it important?

In small sample sizes or with very high/low proportions, asymptotic normal approximations may lead to inaccurate power calculations. 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 it 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 EastXacts's specific capabilities, along with license and training options.


 



To learn more...
call +1.617.661.2011

or if from a company, email your request to
Evan Hahn
ehahn@cytel.com

if from an academic or non-profit outfit email
Nina Kohen
nina@cytel.com