Randomization
Introduction
Randomization models the distribution of patients to treatment arms.
Notes
Randomization specification can occur using sentences or using visit action randomize. If visit action randomize is used, then randomization specification using sentences is ignored.
If more than one randomization should be modeled (re-randomization), visit action randomize must be used.
Randomization specification using sentences
Syntax
Patients will be randomized at visit [randomization visit] between treatment arms: [treatment arm 1, treatment arm 2, … and treatment arm n].
Randomization ratio: [treatment arm 1 ratio] : [treatment arm 2 ratio] : … : [treatment arm n ratio]
Example
Patients will be randomized at V1 between treatment arms: TA and TB.
Randomization ratio: 1:1.
Randomization visit
Definition
Visit code of visit where randomization should occur.
Rules
The randomization visit must be a valid visit in the visit schedule. If an invalid randomization visit is entered, a warning with the following message is shown:
No randomization visit was found - passing randomization interpretation.
In forecast calculations with RTSM data extract, the randomization visit specified in 4C Supply® must map correctly to the randomization visit in the RTSM. This can be verified in the RTSM data extract mapping input screen.
If the randomization visit specified in 4C Supply® is earlier in the visit schedule than the randomization visit specified in the RTSM, then there may be patients in the extract without a treatment arm for whom 4C Supply® expects a treatment arm. This will generate a forecast calculation error.
If the randomization visit specified in 4C Supply® is later in the visit schedule than the randomization visit specified in the RTSM, then there may be patients in the extract with a treatment for whom 4C Supply® does not expect a treatment arm. This may cause the treatment arm of the respective patient to be overwritten in the forecast.
Treatment arms
Definition
Treatment arm code of treatment arms patients are randomized to.
Rules
In forecast calculations with RTSM data extract, the treatment arms specified in 4C Supply® must map correctly to the corresponding treatment arms in the RTSM. This can be verified in the RTSM data extract mapping input screen.
Randomization ratio
Definition
The randomization ratio defines the proportions in which patients are distributed to treatment arms.
Rules
In forecast calculations with RTSM data extract, if a different randomization ratio is specified in 4C Supply® than in the RTSM, all future patients will be forecasted to be randomized according to the ratio specified in 4C Supply®, potentially causing errors in the calculation of demand and supply.