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Analyze Binary Data Using Formula 28.2 from the East Manual

AnalyzeBinaryUsingEastManualFormula.Rd

This function computes the test statistic using formula 28.2 from the East manual, which is designed for analyzing binary data in group sequential designs. It demonstrates how analysis and decision-making can be customized in a simple approach. The test statistic is compared to the upper efficacy boundary provided by East or East Horizon as input. Note that this example does not include a futility rule.

Usage

AnalyzeBinaryUsingEastManualFormula(
  SimData,
  DesignParam,
  LookInfo = NULL,
  UserParam = NULL
)

Arguments

SimData

A data frame containing data generated in the current simulation.

DesignParam

A list of design and simulation parameters required for analysis.

LookInfo

A list of input parameters related to multiple looks in group sequential designs. Variables should be accessed by names (e.g., LookInfo$NumLooks). Important variables include:

  • LookInfo$NumLooks: Integer, number of looks in the study.

  • LookInfo$CurrLookIndex: Integer, current look index (starting from 1).

  • LookInfo$CumEvents: Vector, cumulative number of events at each look.

  • LookInfo$RejType: Code representing rejection types. Possible values include:

  • Efficacy Only:

    • 0: 1-Sided Efficacy Upper.

    • 2: 1-Sided Efficacy Lower.

  • Futility Only:

    • 1: 1-Sided Futility Upper.

    • 3: 1-Sided Futility Lower.

  • Efficacy and Futility:

    • 4: 1-Sided Efficacy Upper and Futility Lower.

    • 5: 1-Sided Efficacy Lower and Futility Upper.

UserParam

A list of user-defined parameters provided by East or East Horizon. Defaults to NULL. In this example, user-defined parameters are not included.

Value

A list containing the following elements:

TestStat

A double representing the computed test statistic.

Decision

Required integer value indicating the decision made:

0

No boundary crossed (neither efficacy nor futility).

1

Lower efficacy boundary crossed.

2

Upper efficacy boundary crossed.

3

Futility boundary crossed.

4

Equivalence boundary crossed.

ErrorCode

Optional integer value:

0

No error.

> 0

Non-fatal error; current simulation is aborted but subsequent simulations continue.

< 0

Fatal error; no further simulations are attempted.

Delta

Estimated difference between experimental and control treatments.