ADDPLAN allows to select between commonly used group sequential designs including the designs proposed by O’Brien and Fleming (1979), Pocock (1977), Wang and Tsiatis (1987), Pampallona and Tsiatis (1994), and alpha and beta spending function designs. Binding and non-binding stopping for futility bounds are defined either by design, or can be directly entered by the user.
Power calculation and sample size planning facilities are included for the following designs:
Output in the planning phase is comprised of the total sample size in a comparable fixed sample design, total maximum sample size according to the group sequential plan, average sample size (ASN), as well as power achieved, alpha spent, and beta spent if early rejection of the alternative is possible.
Graphical output comprised of plots of stopping boundaries, power, ASN and maximum sample size.
Adaptive designs allow the use of data from an interim analysis to recalculate the sample size for the ongoing trial. The recalculation can follow various methods that differ in the conditional power arguments on which they are based. The simulation module in ADDPLAN includes the assessment of different sample size recalculation methods.
Simulations are available for all designs (with the exception of the general design) that are available in the planning phase.
Once a design is specified, the user can study the impact of
on the performance of the trial in terms of power and ASN in case of testing of means, rates, or expected number of events/expected duration in case of survival designs.
ADDPLAN allows for the convenient interactive analysis of user supplied data within an adaptive design. ADDPLAN enables the user to utilize data from an interim analysis to recalculate the sample size of an ongoing trial.
In the analysis phase, the user specifies which design will be used for data analysis and sample size recalculation/adaptive redesign. All designs that were available in the planning phase are also available for analysis.
Upon choosing a design, the user has the choice between various forms of interim analysis including:
Graphical output comprises plots of stopping boundaries along with test statistics, and plots of the conditional power and likelihood vs effect.
Design Your Trial
All Relevant Group Sequential Designs
Compare Your Effect Size
Ready-to-Use Text Modules
Visualize Your Decision Boundaries
Simulate Your Trial Design
Compare Test Strategies
Assess Survival Assumptions
Assess Treatment Arm Selection Rules
Produce Your Own Charts and Tables
Analyze Your Data
Seamless Phase II/III Combinations
Visualize Your Trial's Progress
Recalculate the Sample Size
Demonstrate the Conditional Power
Redesign Your Trial
Audit Trial Information