EastAdapt®

Expand East 5's Design and Simulation Capabilities with the Latest Adaptive Methodologies

Every clinical trial design requires the sponsor make assumptions about both the unknown effect size and the unknown nuisance parameters. The subsequent operating characteristics, and the ultimate success of any trial depends greatly on the accuracy of these assumptions. Traditional trials pre-specify these parameters - prohibiting any chance of beneficial design "tuning" once the trial has begun.

Adaptive trial designs change all that. Recently introduced flexible designs use knowledge gained from the ongoing trial via planned, interim looks - periodic analysis of a trial's actual performance. By considering actual trial data as it progresses, sponsors can revise the assumed primary and nuisance parameters - all while preserving the study's statistical validity and integrity.

With the growing validation of flexible designs adaptive approaches are increasingly utilized by trial sponsors and accepted by regulators. Cytel is an acknowledged pioneer in the research and development of the advanced statistics that make adaptive trials possible and practical.

Cytel's unique EastAdapt software module implements three adaptive and flexible design methods proposed by Cui, Hung and Wang (Biometrics, 1999) for down-weighting the second stage contribution to the test statistic; by Proschan and Hunsberger (Biometrics, 1995) for adjusting the critical rejection region; and by Muller and Schafer (Biometrics, 2001) for combining p-values and preserving the conditional type I error.

EastAdapt provides sponsors with the flexibility to make data-dependent design modifications to an ongoing trial while preserving type I error.
Possible changes include:

• Increasing or decreasing the sample size
• Modifying the error spending function
• Changing the number and spacing of interim looks
• Refining the primary hypothesis

Please contact us for more information on EastAdapt's specific capabilities, along with license and training options.