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| Crossover Design (Latin Square) |
This example assumes a crossover design in which the applicant-defined protocol specifies the following information. All subjects are to be screened for 10 days prior to randomization into 4 protocol groups:
- Group 1 is a control group of 20 subjects, 10 male and 10 female, which are to be dosed with vehicle once per day for 14 days, given a 7-day rest period, dosed again with vehicle once per day for 14 days, given a second 7-day rest period, and dosed with vehicle once per day for the final 14 days.
- Group 2 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 50 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 800 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 400 mg/kg once per day for the final 14 days.
- Group 3 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 400 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg once per day for the final 14 days.
- Group 4 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 800 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg once per day for the final 14 days.
There are no other experimental factors of interest specified in the study design.
| Excerpt Include |
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| Figure. Example Trial 5 Design |
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| Figure. Example Trial 5 Design |
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Trial Elements
This example shows the start and end rules and durations for the different treatment elements, indicating whether they follow a treatment or nontreatment element.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-216 |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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| 1 | TDM5 | TE | SCRN | Screen | Start of Pretreatment | 10 days after start of Element | P10D | | 2 | TDM5 | TE | CONTROL | Vehicle Control | First dosing with vehicle control following a nontreatment Element | 14 days after start of Element | P14D | | 3 | TDM5 | TE | REST | Rest for 7 days | 1 day after last dose in a treatment Element | 7 days after start of Element | P7D | | 4 | TDM5 | TE | 50A | 50 mg/kg Drug A, once daily | First dosing with 50 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D | | 5 | TDM5 | TE | 400A | 400 mg/kg Drug A, once daily | First dosing with 400 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D | | 6 | TDM5 | TE | 800A | 800 mg/kg Drug A, once daily | First dosing with 800 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D | |
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Trial Arms
Based upon the description, there are 4 trial arms.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
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| 1 | TDM5 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | PRE-TREATMENT | | 2 | TDM5 | TA | 1 | Control | 2 | CONTROL | Vehicle Control |
| TREATMENT | | 3 | TDM5 | TA | 1 | Control | 3 | REST | Rest for 7 days |
| WASHOUT | | 4 | TDM5 | TA | 1 | Control | 4 | CONTROL | Vehicle Control |
| TREATMENT | | 5 | TDM5 | TA | 1 | Control | 5 | REST | Rest for 7 days |
| WASHOUT | | 6 | TDM5 | TA | 1 | Control | 6 | CONTROL | Vehicle Control |
| TREATMENT | | 7 | TDM5 | TA | 2 | 50-800-400 | 1 | SCRN | Screen | Randomized to Group 2 | PRE-TREATMENT | | 8 | TDM5 | TA | 2 | 50-800-400 | 2 | 50A | 50 mg/kg Drug A |
| TREATMENT | | 9 | TDM5 | TA | 2 | 50-800-400 | 3 | REST | Rest for 7 days |
| WASHOUT | | 10 | TDM5 | TA | 2 | 50-800-400 | 4 | 800A | 800 mg/kg Drug A |
| TREATMENT | | 11 | TDM5 | TA | 2 | 50-800-400 | 5 | REST | Rest for 7 days |
| WASHOUT | | 12 | TDM5 | TA | 2 | 50-800-400 | 6 | 400A | 400 mg/kg Drug A |
| TREATMENT | | 13 | TDM5 | TA | 3 | 400-50-800 | 1 | SCRN | Screen | Randomized to Group 3 | PRE-TREATMENT | | 14 | TDM5 | TA | 3 | 400-50-800 | 2 | 400A | 400 mg/kg Drug A |
| TREATMENT | | 15 | TDM5 | TA | 3 | 400-50-800 | 3 | REST | Rest for 7 days |
| WASHOUT | | 16 | TDM5 | TA | 3 | 400-50-800 | 4 | 50A | 50 mg/kg Drug A |
| TREATMENT | | 17 | TDM5 | TA | 3 | 400-50-800 | 5 | REST | Rest for 7 days |
| WASHOUT | | 18 | TDM5 | TA | 3 | 400-50-800 | 6 | 800A | 800 mg/kg Drug A |
| TREATMENT | | 19 | TDM5 | TA | 4 | 800-400-50 | 1 | SCRN | Screen | Randomized to Group 4 | PRE-TREATMENT | | 20 | TDM5 | TA | 4 | 800-400-50 | 2 | 800A | 800 mg/kg Drug A |
| TREATMENT | | 21 | TDM5 | TA | 4 | 800-400-50 | 3 | REST | Rest for 7 days |
| WASHOUT | | 22 | TDM5 | TA | 4 | 800-400-50 | 4 | 400A | 400 mg/kg Drug A |
| TREATMENT | | 23 | TDM5 | TA | 4 | 800-400-50 | 5 | REST | Rest for 7 days |
| WASHOUT | | 24 | TDM5 | TA | 4 | 800-400-50 | 6 | 50A | 50 mg/kg Drug A |
| TREATMENT |
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Trial Sets
In this example, there are 4 trial sets. The experimental factors considered are type of treatment (vehicle control or compound) and sequencing of treatment levels. The applicant is providing the arm code, applicant-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 1 | ARMCD | Arm Code | 1 | | 2 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 2 | SPGRPCD | Applicant-Defined Group Code | 1 | | 3 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 3 | GRPLBL | Group Label | Group 1, Control | | 4 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 4 | TCNTRL | Control Type | VEHICLE CONTROL | | 5 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 5 | TRTDOS | Dose Level | 0 | | 6 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 6 | TRTDOSU | Dose Units | mg/kg/day | | 7 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 7 | SPLANSUB | Planned Number of Subjects | 20 | | 8 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 8 | ARMCD | Arm Code | 2 | | 9 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 9 | SPGRPCD | Applicant-Defined Group Code | 2 | | 10 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 10 | GRPLBL | Group Label | Group 2, 50-800-400 mg/kg/day | | 11 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 11 | TRTDOS | Dose Level | SEE PROTOCOL | | 12 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 12 | TRTDOSU | Dose Units | SEE PROTOCOL | | 13 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 13 | SPLANSUB | Planned Number of Subjects | 20 | | 14 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 14 | ARMCD | Arm Code | 3 | | 15 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 15 | SPGRPCD | Applicant-Defined Group Code | 3 | | 16 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 16 | GRPLBL | Group Label | Group 3, 400-50-800 mg/kg/day | | 17 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 17 | TRTDOS | Dose Level | SEE PROTOCOL | | 18 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 18 | TRTDOSU | Dose Units | SEE PROTOCOL | | 19 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 19 | SPLANSUB | Planned Number of Subjects | 20 | | 20 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 20 | ARMCD | Arm Code | 4 | | 21 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 21 | SPGRPCD | Applicant-Defined Group Code | 4 | | 22 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 22 | GRPLBL | Group Label | Group 4, 800-400-50 mg/kg/day | | 23 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 23 | TRTDOS | Dose Level | SEE PROTOCOL | | 24 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 24 | TRTDOSU | Dose Units | SEE PROTOCOL | | 25 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 25 | SPLANSUB | Planned Number of Subjects | 20 |
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