The following diagram for a crossover trial study does not use the crossing slanted lines sometimes used to represent crossover trialsstudies, because the order of the blocks is sufficient to represent the design of the trialstudy. Slanted lines are used only to represent the branch point at randomization, when a subject is assigned to a sequence of treatmentsstudy product exposures. As in most crossover trialsstudies, the arms are distinguished by the order of treatmentsstudy product exposures, with the same treatments study product exposure present in each arm. Note that even though all 3 arms of this trial study end with the same block (i.e., the block for the follow-up element), the diagram does not show the arms converging into one block. Also note that the same block (the "rest" element) occurs twice within each arm. Elements are conceived of as "reusable" and can appear in more than 1 arm, in more than 1 epoch, and more than once in an arm.
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| SDTMIG:Example Study 2, Crossover Trial Study Schema |
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| Example Study 2, Crossover Trial Study Schema |
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| SDTMIG:Example Study 2, Crossover Trial Study Schema |
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| Example Study 2, Crossover Trial Study Schema |
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The next diagram for this crossover trial study shows the prospective view of the trialstudy; it identifies the epoch and arms of the trialstudy, and gives each a name. As for most crossover studies, the objectives of the trial study will be addressed by comparisons between the arms and by within-subject comparisons between treatmentsstudy product exposures. Because the design depends on differentiating the periods during which the subject receives the 3 different treatmentsstudy product exposures, there are 3 different treatment study product exposure epochs. The fact that the rest periods are identified as separate epochs suggests that these also play an important part in the design of the trialstudy; they are probably designed to allow subjects to return to “baseline,” with data collected to show that this occurred. Note that epochs are not considered reusable; each epoch has a different name, even though all the treatment study product exposure epochs are similar and both the rest epochs are similar. As with the first example trialstudy, there is a one-to-one relationship between the epochs of the trial study and the elements in each arm.
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| Example Study 2, Crossover Study Prospective View |
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| Example Study 2, Crossover Study Prospective View |
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| Example Study Trial 2, Crossover Trial Study Prospective View |
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| Example Trial Study 2, Crossover Trial Study Prospective View |
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The next diagram shows the retrospective view of the trialstudy.
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| Example Study 2, Crossover Trial Retrospective View |
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| Example Study 2, Crossover Trial Retrospective View |
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| Example Study 2, Crossover Trial Retrospective View |
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| Example Study 2, Crossover Trial Retrospective View |
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The last diagram for this trial study shows the trial study from the viewpoint of blinded participants. As in the simple parallel trial study in Example Trial Study 1, blinded participants see only 1 sequence of elements; during the treatment product exposure epochs they do not know which of the treatment product exposure elements a subject is in.
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| Example Study 2, Crossover Study Blinded View |
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| Example Study 2, Crossover Study Blinded View |
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| Example Study Example Trial 2, Crossover Trial Study Blinded View |
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| Example Trial Study 2, Crossover Trial Study Blinded View |
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The following table illustrates the trial study design matrix for this crossover example trialstudy. It corresponds closely to the preceding retrospective diagram.
Trial Design Matrix
| Screen | First TreatmentStudy Product Exposure | First Rest | Second TreatmentStudy Product Exposure | Second Rest | Third TreatmentStudy Product Exposure | Follow-up |
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PU-5A-10B | Screen | Usual Tobacco Product | Rest | Tobacco Product A | Rest | Tobacco Product B | Follow-up |
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5A-PU-10B | Screen | Tobacco Product A | Rest | Usual Tobacco Product | Rest | Tobacco Product B | Follow-up |
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5B-10A-PU | Screen | Tobacco Product B | Rest | Tobacco Product A | Rest | Usual Tobacco Product | Follow-up |
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It is straightforward to produce the TA dataset for this crossover trial study from the diagram showing arms and epochs, or from the trial design matrix.
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Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | TATRANS | EPOCH |
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1 | EX2 | TA | U-A-B | UTP-TPA-TPB | 1 | SCRN | Screen | Randomized to UTP -TPA-TPB |
| SCREENING | 2 | EX2 | TA | U-A-B | UTP-TPA-TPB | 2 | UTP | Usual |
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| STUDY PRODUCT EXPOSURE 1 | 3 | EX2 | TA | U-A-B | UTP-TPA-TPB | 3 | REST | Rest |
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| WASHOUT 1 | 4 | EX2 | TA | U-A-B | UTP-TPA-TPB | 4 | TPA | Prod A |
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| STUDY PRODUCT EXPOSURE 2 | 5 | EX2 | TA | U-A-B | UTP-TPA-TPB | 5 | REST | Rest |
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| WASHOUT 2 | 6 | EX2 | TA | U-A-B | UTP-TPA-TPB | 6 | TPB | Prod B |
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| STUDY PRODUCT EXPOSURE 3 | 7 | EX2 | TA | U-A-B | UTP-TPA-TPB | 7 | FU | Follow-up |
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| FOLLOW-UP | 8 | EX2 | TA | A-U-B | TPA-UTP-TPB | 1 | SCRN | Screen | Randomized to TPA- UTP- TPB |
| SCREENING | 9 | EX2 | TA | A-U-B | TPA-UTP-TPB | 2 | TBA | Prod A |
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| STUDY PRODUCT EXPOSURE 1 | 10 | EX2 | TA | A-U-B | TPA-UTP-TPB | 3 | REST | Rest |
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| WASHOUT 1 | 1 | EX2 | TA | A-U-B | TPA-UTP-TPB | 4 | UTP | Usual |
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| STUDY PRODUCT EXPOSURE 2 | 12 | EX2 | TA | A-U-B | TPA-UTP-TPB | 5 | REST | Rest |
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| WASHOUT 2 | 13 | EX2 | TA | A-B-U | TPA-UTP-TPB | 6 | TPB | Prod B |
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| STUDY PRODUCT EXPOSURE 3 | 14 | EX2 | TA | A-B-U | TPA-UTP-TPB | 7 | FU | Follow-up |
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| FOLLOW-UP | 15 | EX2 | TA | A-B-U | TPA-TPB-Usual | 1 | SCRN | Screen | Randomized to TBA - TPB – Usual |
| SCREENING | 16 | EX2 | TA | A-B-U | TPA-TPB-Usual | 2 | TPA | Prod A |
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| STUDY PRODUCT EXPOSURE 1 | 17 | EX2 | TA | A-B-U | TPA-TPB-Usual | 3 | REST | Rest |
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| WASHOUT 1 | 18 | EX2 | TA | A-B-U | TPA-TPB-Usual | 4 | TPB | Prod B |
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| STUDY PRODUCT EXPOSURE 2 | 19 | EX2 | TA | A-B-U | TPA-TPB-Usual | 5 | REST | Rest |
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| WASHOUT 2 | 20 | EX2 | TA | A-B-U | TPA-TPB-Usual | 6 | UTP | Usual |
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| STUDY PRODUCT EXPOSURE 3 | 21 | EX2 | TA | A-B-U | TPA-TPB-Usual | 7 | FU | Follow-up |
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| FOLLOW-UP | |
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