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Analyze Continuous Data Using East Manual Formula

AnalyzeContinuousUsingEastManualFormula.Rd

Compute the test statistic using formula Q.3.3 in the East manual. This example demonstrates how analysis and decision-making can be modified in a simple approach. The test statistic is compared to the upper boundary computed and sent by East or East Horizon as an input. Note that this example does not include a futility rule. It performs a two-sample Z test for a normal distribution with the assumption that the number of looks is greater than one.

Usage

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

Arguments

SimData

Data frame consisting of data generated in the current simulation.

DesignParam

List of design and simulation parameters required to perform 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 in East or East Horizon. The default is NULL. For 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.