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Analyze Continuous Data Using Mean Limits of Confidence Interval

AnalyzeContinuousUsingMeanLimitsOfCI.Rd

This function performs analysis using a simplified limits of confidence interval design for continuous outcomes. The analysis determines whether a "Go" or "No-Go" decision is made based on the lower and upper limits of a user-specified confidence interval. It uses the t.test function from the base R library to compute the confidence interval. The decision-making process is based on the following logic:

  • If the lower limit of the confidence interval (LL) is greater than the Minimum Acceptable Value (MAV), a "Go" decision is made.

  • If a "Go" decision is not made, and the upper limit of the confidence interval (UL) is less than the Target Value (TV), a "No-Go" decision is made.

  • Otherwise, continue to the next analysis.

  • At the final analysis, if LL > MAV, a "Go" decision is made; otherwise, a "No-Go" decision is made.

This function assumes MAV ≤ TV and ignores boundary information sent from East or East Horizon to implement this decision approach.

Usage

AnalyzeContinuousUsingMeanLimitsOfCI(
  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 the 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. Must contain the following named elements:

UserParam$dMAV

Numeric; specifies the Minimum Acceptable Value (MAV).

UserParam$dTV

Numeric; specifies the Target Value (TV).

UserParam$dConfLevel

Numeric (0,1); specifies the confidence level for the t.test() function.

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.

Note

This function is applicable only when MAV ≤ TV.