CheckTrialMonitor: Check Trial Monitor

In kwathen/OCTOPUS: OCTOPUS

Check Trial Monitor

Description

CheckTrialMonitor An ISA monitoring plan consists of the specifying a minimum number of patients and follow-up (FU) time. You must specify the minimum number of patients to perform an analysis and the final analysis FU time. This is done by specifying the elements vMinQtyPats and vMinFUTime with at least 2 elements. The first elements define when to start monitoring based on a number of patients enrolled with additional FU (in months) and the last elements in the vectors define when to do the final analysis.

To increase flexibility there are two options for adding additional IAs. Which option is used is based on dQtyMonthsBtwIA ==0 or > 0

1. Option 1: vMinQtyPats and vMinFUTime are of equal length with length > 2 then the trial would consist of length( vMinQtyPats )-1 IAs and 1 FA. See Example 1.

2. Option 2: You MUST have the lengths of vMinQtyPats and vMinFUTime equal to 2. See Example 3

Usage

CheckTrialMonitor(
  cISADesigns,
  lEnrolledPats,
  vISAStatus,
  dCurrentTime,
  vISAAnalysisIndx,
  vPreviousIATime
)

Value

Return: list( vRunISAAnalysis, vPreviousIATime ) vRunISAAnalysis = 1 if the ISA needs to have the IA run and 0 otherwise vPreviousIATime > 0 for the option when vQtyMonthsBtw[1] > 0 so we can track when the IA is done and know when the next one is to be done.

In both cases, vIsFinalISAAnalysis = TRUE if dCurrentTime >= time of the FA as defined above; otherwise it is set to FALSE

If vISAStatus != 1 then for the corresponding ISA elements in the return list this function returns vRunISAAnalysis = 0, vPreviousIATime = vPreviousIATime , vIsFinalISAAnalysis = FALSE, vCase = corresponding case )

See Also

View Code on GitHub

Examples

## Not run: 
# Example 1 :   Perform  IA 1 at 3 months after the 30th patient enrolled, IA 2 at 3 months after the 90th patient enrolled, IA 3 when the 150th patient enrolled,
#               (not since the 3rd element of vMinFUTime = 0 IA 3 is performed when the 150th patient is enrolled) and the FA is performed 3 months after the 200th patient.

     dQtyMonthsBtwIA <- 0
     vMinQtyPats     <- c( 30, 90, 150, 200 )
     vMinFUTime      <- c( 3,  3,  0,    3)

#Example 2 - 1 Interim analysis (IA) at 30 patients with 3 months of FU
#            No additional IA
#            Final Analysis (FA) at 200 patients with 3 months FU

     dQtyMonthsBtwIA <- 0
     vMinQtyPats     <- c( 30, 200 )
     vMinFUTime      <- c( 3,   3)

#Example 3 - Start the IA 30 patients with 3 months of FU, continue
#            Perform additional analysis every 2 months after the first IA
#            Final Analysis (FA) at 200 patients with 3 months FU

     dQtyMonthsBtwIA <- 2
     vMinQtyPats     <- c( 30, 200 )
     vMinFUTime      <- c( 3,   3)

#Example 4 - No IA becasue the IA is done at the same time as the FA
     dQtyMonthsBtwIA <- 0
     vMinQtyPats     <- c( 200, 200 )
     vMinFUTime      <- c( 3,   3)


## End(Not run)

kwathen/OCTOPUS documentation built on Oct. 24, 2024, 12:36 p.m.