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As illustrated in the study schema diagram for Example Trial 1, this simple parallel trial has 3 arms, corresponding to the 3 possible left-to-right "paths" through the trial. Each path corresponds to 1 of the 3 treatment elements at the right end of the diagram. Randomization is represented by the 3 red arrows leading from the Run-in block.
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As illustrated in the following table, the columns of a trial design matrix are the epochs of the trial, the rows are the arms of the trial, and the cells of the matrix (the study cells) contain elements. Note that randomization is not represented in the trial design matrix. All of the preceding diagrams and the trial design matrix are alternative representations of the trial design. None of them contains all the information that will be in the finished TA dataset; users may find it useful to draw some or all of these diagrams when working out the dataset.
Trial Design Matrix
| Screen | Run-in | Treatment | |
|---|---|---|---|
| Placebo | Screen | Run-in | PLACEBO |
| A | Screen | Run-in | DRUG A |
| B | Screen | Run-in | DRUG B |
For Example Trial 1, the conversion of the trial design matrix into the TA dataset is straightforward. For each cell of the matrix, there is a record in the TA dataset. ARM, EPOCH, and ELEMENT can be populated directly from the matrix. TAETORD acts as a sequence number for the elements within an arm, so it can be populated by counting across the cells in the matrix. The randomization information, which is not represented in the trial design matrix, is held in TABRANCH in the TA dataset. TABRANCH is populated only if there is a branch at the end of an element for the arm. When TABRANCH is populated, it describes how the decision at the branch point would result in a subject being in this arm.
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