Integration Point: Design - Multiple Endpoints • CyneRgy

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Description

The Design integration point allows you to implement custom decision-making logic for Multiple Endpoints designs. You can customize the statistical test for the treatment effect, the multiplicity adjustment method, and the decision rules instead of relying on East Horizon’s parameters. This integration point is similar to the Analysis and Multiplicity Adjustment integration points of other designs. Design functions are called at each analysis look to make decisions about endpoint efficacy, futility and trial continuation based on user-defined criteria.

Availability

East Horizon Design

This integration point is available in East Horizon Design for the following study objectives and endpoint types:

	Time to Event	Binary	Continuous	Continuous with repeated measures	Count	Composite	Dual TTE-TTE	Dual TTE-Binary
Two Arm Confirmatory	❌	❌	❌	❌	❌	❌	❌	❌
Two Arm Confirmatory - Multiple Endpoints	✅	✅	✅	-	-	-	-	-
Multiple Arm Confirmatory	❌	❌	❌	-	-	-	-	-
Dose Finding	-	-	❌	-	-	-	-	-

Legend

Icon	Meaning
✅	Available
❌	Not available
🔜	Coming soon

Instructions

In East Horizon Design

You can set up a design function under User Specified Analysis in the Design Tab while creating or editing an Input Set.

Follow these steps (click to expand/collapse):

Select User Specified-R from the dropdown in the User Specified Analysis field in the Design Tab.
Browse and select the appropriate R file (filename.r) from your computer, or use the built-in R Code Assistant to create one. This file should contain function(s) written to perform various tasks to be used throughout your Project.
Choose the appropriate function name. If the expected function is not displaying, then check your R code for errors.
Set any required user parameters (variables) as needed for your function using + Add Variables.
Continue creating your project by specifying scenarios for patient Response, Enrollments, etc.

For a visual guide of where to find the option, refer to the screenshot below:

Input Variables

When creating a custom R script, you can optionally use specific variables provided by East Horizon’s engine itself. These variables are automatically available and do not need to be set by the user, except for the UserParam variable. Refer to the table below for the variables that are available for this integration point, outcome, and study objective.

Variable	Type	Description
SimData	Data Frame	Subject data generated in current simulation, one row per subject. To access these variables in your R code, use the syntax: `SimData$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate variable name. See below for more information.
AnalysisData	Data Frame	Subset of `SimData`, containing the patient data available at the current analysis look. For `Statistical Design = Fixed Sample`, contains information for the single look. To access these variables in your R code, use the syntax: `AnalysisData$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate variable name. See `SimData` for more information.
DesignParam	List	Input parameters which may be needed to compute test statistics and perform tests. To access these variables in your R code, use the syntax: `DesignParam$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate variable name. See below for more information.
LookInfo	List	Input parameters related to multiple looks. For `Statistical Design = Fixed Sample`, contains information for the single look. To access these variables in your R code, use the syntax: `LookInfo$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate variable name. See below for more information.
DataSummary	List	Summary statistics for each endpoint. To access these variables in your R code, use the syntax: `DataSummary[[EPNAME]]$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate variable name and `EPNAME` by the endpoint name. See below for more information.
OutList	List	List of outputs that was returned in the previous look. Only relevant for `Statistical Design = Group Sequential`. Set to `NULL` for the first look. See below in the Output Variable.
UserParam	List	Contains all user-defined parameters specified in the East Horizon interface (refer to the Instructions section). To access these parameters in your R code, use the syntax: `UserParam$NameOfTheVariable`, replacing `NameOfTheVariable` with the appropriate parameter name.

Note: “Endpoint 1” is used as a sample endpoint name. It will be the actual endpoint name as specified by the user.

Variables of DataSummary

To access these variables in your R code, use the syntax: DataSummary[[EPNAME]]$NameOfTheVariable, replacing NameOfTheVariable with the appropriate variable name, and EPNAME by the endpoint name specified in East Horizon. Endpoint names can also be accessed using DesignParam$EndpointName.

Variable	Description	Notes
AvgFollowupTime	Mean follow-up time.
MedianFollowupTime	Median follow-up time.
Dropouts	Total number of dropouts.
Dropouts0	Number of dropouts in control arm.
Dropouts1	Number of dropouts in treatment arm.
Censored	Total number of censored subjects.
Censored0	Number of censored subjects in control arm.
Censored1	Number of censored subjects in treatment arm.
Pendings	Total number of pending events or completers.
Pendings0	Number of pending events or completers in the control arm.
Pendings1	Number of pending events or completers in the treatment arm.
Events	Total number of events.	Only available for `Endpoint Type = Time-to-Event`.
Events0	Number of events in control arm.	Only available for `Endpoint Type = Time-to-Event`.
Events1	Number of events in treatment arm.	Only available for `Endpoint Type = Time-to-Event`.
Completers	Total number of completers.	Only available for `Endpoint Type = Continuous or Binary`.
Completers0	Number of completers in control arm.	Only available for `Endpoint Type = Continuous or Binary`.
Completers1	Number of completers in treatment arm.	Only available for `Endpoint Type = Continuous or Binary`.
HR	Estimated hazard ratio comparing treatment to control.	Only available for `Endpoint Type = Time-to-Event`.
HR0	Hazard-related summary for the control arm.	Only available for `Endpoint Type = Time-to-Event`.
HR1	Hazard-related summary for the treatment arm.	Only available for `Endpoint Type = Time-to-Event`.
Mean0	Mean outcome value in the control arm.	Only available for `Endpoint Type = Continuous`.
Mean1	Mean outcome value in the treatment arm.	Only available for `Endpoint Type = Continuous`.
SD0	Standard deviation of the outcome in the control arm.	Only available for `Endpoint Type = Continuous`.
SD1	Standard deviation of the outcome in the treatment arm.	Only available for `Endpoint Type = Continuous`.
Delta	Estimated treatment effect.	Only available for `Endpoint Type = Continuous or Binary`
Prop0	Observed proportion of responders in the control arm.	Only available for `Endpoint Type = Binary`.
Prop1	Observed proportion of responders in the treatment arm.	Only available for `Endpoint Type = Binary`.

Expected Output Variable

East Horizon expects an output of a specific type. Refer to the table below for the expected output for this integration point:

Output	Type	Description
Response	Named List of Vector of Numeric	Named List of length equal to the number of endpoints, containing the survival time or response outputs for each endpoint. For example, `Response[“Endpoint 1”]` is the vector of generated response values for each subject for Endpoint 1. Order also matches `DesignParam$EndpointName` order. The length of each vector is equal to the number of subjects.
OutList	List	Optional. List of outputs to pass to the next look. Only relevant for `Statistical Design = Group Sequential`. Will be available as input to this function in the next look. See above in the Input Variables.
RawPVal	Vector	Optional. Vector of raw p-values for each endpoint.
EfficacyBoundary	Vector	Optional. Vector of efficacy boundaries.
WinStatus	Integer	Optional. Trial win status: `0` = No Decision, `1` = Win, `-1` = Lose.
Score	Vector	Optional. Vector of score statistics.
StdErr	Vector	Optional. Vector of standard errors.
PropPld	Vector	Optional. Vector of pooled proportions.
SDPld	Vector	Optional. Vector of pooled standard deviations.
ErrorCode	Integer	Optional. Can be used to handle errors in your script: – `0`: No error. – `Positive Integer`: Nonfatal error, the current simulation will be aborted, but the next simulation will proceed. – `Negative Integer`: Fatal error, no further simulations will be attempted.

Minimal Template

Your R script could contain a function such as this one, with a name of your choice. All input variables must be declared, even if they are not used in the script. We recommend always declaring UserParam and OutList as a default NULL value in the function arguments, as this will ensure that the same function will work regardless of whether the user has specified any custom parameters in the interface and whether or not OutList is used.

A detailed template with step-by-step explanations is available here: Design.MEP.R

GetMEPDecision <- function( SimData, AnalysisData, DataSummary, LookInfo, DesignParam, OutList = NULL, UserParam = NULL )
{
    nError  = 0 # Error handling (no error)
    
    Decision = list()
    EndpointName <- DesignParam$EndpointName
    Decision[ EndpointName[[ 1 ]]] = 0 # Initialize decision for endpoint 1
    Decision[ EndpointName[[ 2 ]]] = 0 # Initialize decision for endpoint 2
    
    # Get number of endpoints
    nNumEP <- length(DesignParam$EndpointName)
    for (nEPID in 1:nNumEP) {
        # Get endpoint name and type
        strEPName <- DesignParam$EndpointName[nEPID]
        nEPType <- DesignParam$EndpointType[nEPID]
        # More code here...
    }
    
    OutList = list()
    OutList$OutVal = 0 # This value will be passed to the next look
    
    # Write the actual code here.
    
    return( list( Decision = as.list( Decision ), OutList = as.list( OutList ), ErrorCode = as.integer( nError )))
}

Example

Explore the following example for more context:

Multiple Endpoints - Design
- GetMEPDecision.R

Integration Point: Design - Multiple Endpoints

Gabriel Potvin

January 09, 2026