Design, Simulate and Monitor Superiority and Non-Inferiority Survival Trials

EastSurv™ is the premier survival study design tool that reduces typical trial duration, subjects and costs in oncology and cardiovascular and infectious disease studies, including HIV and hepatitis.

Time-to-event endpoints present a particularly important challenge for clinical trial designers. Because power depends on the number and distribution of events among the treatment arms during the trial's course rather than on sample size, typical complications that arise during the study – such as subject drop-outs, treatment cross-over and uncertain control arm event rates – are difficult to fully grasp without capable design and simulation tools.

Successful survival designs require planners correctly address such difficult questions as:

• How many events must be observed to obtain a properly powered trial?
• How long will the trial last and how many subjects will need to be enrolled?
• When and how can events be expected to come in?
• How frequently should the Data Monitoring Committee convene?
• When and in what form can events be expected to occur?
• Should more subjects be enrolled and/or follow-up time be increased if events do not occur at the expected rate?
• How will drop-outs, non-constant accrual or even non-proportional hazards affect the trial’s design and operating characteristics?

Simple assumptions are simply inadequate – and don’t account for variable enrollment rates, non-constant hazard functions, and variable differential drop-outs.

Cytel’s EastSurv option for East® enables superior survival study designs with superior methods to address complex parameter assumptions. EastSurv helps trials designers make the toughest design decisions with confidence by accounting for:

• variable subject drop-outs
• non-uniform accrual
• non-constant hazard rates
• variable and fixed subject follow-up
• lagged treatment effects and other non-proportional hazards scenarios

New EastSurv capabilities include:

• option to specify accrual & study duration or accrual rate & sample size
• multiple survival and drop-out parameter input methods
• interactive event rate charts to predict accrual and accumulation of events over time
• variable and fixed subject follow-up
• power charts based on sample size, accrual duration, study duration and number of events

EastSurv now features powerful yet simple simulation tools. Specify data generating parameters easily and intuitively to have EastSurv simulate complex survival data, then saved for further analysis. In addition, at each interim look and the final look, EastSurv provides fixed sample size and group sequential hypothesis testing, as well as Monte Carlo averages of follow-up time, plus cumulative accruals, events and drop-outs in each treatment group.

Please contact us to better understand how EastSurv can help your team design better survival studies along with licensing and training options.