East EXACT

Exact Inference in East with East EXACT

Small sample sizes present a unique set of challenges for clinical trials using binomial endpoints. Valid results require careful, knowledgeable implementation of complex exact tests.

Cytel, a leading developer of exact and Monte Carlo tests and simulations for small sample analyses, now provides East EXACT for designs with small samples.

Features

Group Sequential Designs for binomial superiority tests with one sample (single proportion).

Single Look Fixed Sample Designs including: Binomial superiority designs for one and two samples; binomial noninferiority designs for two samples; binomial equivalence designs for two samples; and Simon's Two-Stage Design.

East EXACT's binomial superiority tests include designs for single and paired proportions, difference of proportions and ratio of proportions. The tooklit of noninferiority tests also provide designs for difference of proportions and ratio of proportions.

What are Simon's Two Stage Designs?

Simon's Two Stage Designs are a popular design for Phase II clinical trials. The design, which has been gaining respect and recognition since its introduction in 1980s, is finally available in a validated software package. Learn more about the design at Researchgate:

Simon, Richard. "Optimal two-stage designs for phase II clinical trials."Controlled clinical trials 10.1 (1989): 1-10. (PDF from Researchgate)