Compute Analysis Time for Dual Endpoint (DEP) Designs
ComputeDEPAnalysisTime.RdComputes the calendar analysis time for trials with one or two endpoints, supporting both Fixed Sample Designs and Group Sequential Designs. The function determines when the planned number of events or completers has been reached based on simulated trial data and design parameters.
For Group Sequential Designs, the analysis time is determined according to the current interim look and synchronization endpoint. For Fixed Sample Designs, the analysis time corresponds to the final look when all required events or completers are observed.
Arguments
- SimData
A data frame containing the simulated subject-level data with the following required columns:
- ClndrRespTime
Response times for Endpoint 1.
- CensorIndOrg
Censoring indicators for Endpoint 1.
- ClndrRespTime2
Response times for Endpoint 2.
- CensorIndOrg2
Censoring indicators for Endpoint 2.
- DesignParam
A list of design parameters containing:
- EndpointType
Numeric vector specifying endpoint types (1 = completer, 2 = event).
- EndpointName
Character vector of endpoint names.
- PlanEndTrial
Integer specifying which endpoint(s) define the trial end:
- 1
Both endpoints.
- 2
Endpoint 1 only.
- 3
Endpoint 2 only.
- MaxCompleters
List of target numbers of completers for each endpoint.
- MaxEvents
List of target numbers of events for each endpoint.
- SampleSize
Total sample size.
- LookInfo
Optional list specifying Group Sequential Design information (default =
NULL). When provided, indicates that a GSD is used and must include:- SyncInterim
Endpoint ID used for interim look positioning.
- NumLooks
Total number of looks planned.
- CurrLookIndex
Current look index.
- NumEndpointLooks
Numeric vector giving the number of looks per endpoint.
- CumEvents
List of cumulative event targets per endpoint.
- CumCompleters
List of cumulative completer targets per endpoint.