group sequential design

group sequential design

A clinical trial design rgat allows one to examine the data at specific time points or after a defined number of patients have been entered and followed up, based on a stopping rule derived from repeated significance tests.
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Allocation rule defines how subjects will be allocated to different treatment arms (e.g., response adaptive randomization); sampling rule defines how many subjects will be sampled in the next stage (e.g., sample-size re-estimation); stopping rule defines when to stop the trial (e.g., group sequential design); decision rule defines decisions pertaining to design change, not covered by the other three rules (e.g., changes in hypothesis or study endpoint) (9,10).
It covers different types of designs, from group sequential design to early-phase oncology trials, as well as adaptive trial monitoring and advanced features of the software such as data generation and toolkits.
It covers statistical methods for various adaptive designs such as adaptive group sequential design, adaptive dose-escalation design, adaptive seamless phase II/III trial design, and biomarker-adaptive design.