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

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

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

Successful survival designs require planners correctly address difficult questions

• How many events must be observed to obtain a properly powered trial?
• How long will the trial last and how many subjects will be needed?
• 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 – they don’t account for variable enrollment rates, non-constant hazard functions or variable differential drop-outs.

Cytel’s East® Surv 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 East® Surv 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

East® Surv features powerful yet simple to use simulation tools. Specify data generating parameters easily and intuitively to have East® Surv simulate complex survival data, then saved for further analysis. Then, at each interim look and the final look, East® Surv 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 East® Surv would help your team improve survival study designs, along with licensing and training options.