TOBA-275 - Getting issue details... STATUS

 

This example assumes a design in which the applicant-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

  • Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
  • Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
  • Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
Group
Number
Group LabelDose LevelNumber of Animals (Both Sexes Combined)
NonrecoveryRecovery
1Group 1, ControlVehicle Control1010
2Group 2, 100 mg/kg100 mg/kg/day1010
3Group 3, 500 mg/kg500 mg/kg/day1010

There are no other experimental factors of interest specified in the study design. In this case, the design consists of 6 trial arms, because there are 6 distinct sequences of elements, as depicted in the following figure.

Figure. Example Trial 1 Design
 

Trial Elements

This example includes the start and end rule for the recovery element starting after last dose of the drug or vehicle.

te.xpt

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1TDM1TESCRNScreenStart of Pre-exposure1 week after start of ElementP7D
2TDM1TETRT01Vehicle ControlFirst day of dosing with vehicle control28 days after start of ElementP28D
3TDM1TETRT02100 mg/kg Drug A, once dailyFirst day of dosing with 100 mg/kg Drug A28 days after start of ElementP28D
4TDM1TETRT03500 mg/kg Drug A, once dailyFirst day of dosing with 500 mg/kg Drug A28 days after start of ElementP28D
5TDM1TERECORecoveryFirst day of Recovery7 days after start of ElementP7D
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Trial Arms

The 6 trial arms of this study can be depicted as follows:

ta.xpt

ta.xpt

RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1TDM1TA01Control1SCRNScreenRandomized to Group 1PRE-EXPOSURE
2TDM1TA01Control2TRT01Vehicle Control
EXPOSURE
3TDM1TA01RControl w/ Recovery1SCRNScreenRandomized to Group 1, planned for recoveryPRE-EXPOSURE
4TDM1TA01RControl w/ Recovery2TRT01Vehicle Control
EXPOSURE
5TDM1TA01RControl w/ Recovery3RECORecovery
RECOVERY
6TDM1TA02Low Dose1SCRNScreenRandomized to Group 2PRE-EXPOSURE
7TDM1TA02Low Dose2TRT02100 mg/kg Drug A
EXPOSURE
8TDM1TA02RLow Dose w/ Recovery1SCRNScreenRandomized to Group 2, planned for recoveryPRE-EXPOSURE
9TDM1TA02RLow Dose w/ Recovery2TRT02100 mg/kg Drug A
EXPOSURE
10TDM1TA02RLow Dose w/ Recovery3RECORecovery
RECOVERY
11TDM1TA03High Dose1SCRNScreenRandomized to Group 3PRE-EXPOSURE
12TDM1TA03High Dose2TRT03500 mg/kg Drug A
EXPOSURE
13TDM1TA03RHigh Dose w/ Recovery1SCRNScreenRandomized to Group 3, planned for recoveryPRE-EXPOSURE
14TDM1TA03RHigh Dose w/ Recovery2TRT03500 mg/kg Drug A
EXPOSURE
15TDM1TA03RHigh Dose w/ Recovery3RECORecovery
RECOVERY
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Trial Sets

As noted, there are 6 distinct trial sets. The experimental factors of interest are the dose level to be received during the exposure period and whether the subjects are planned for termination on day 28 or will enter a recovery period.

In this example, the applicant is providing the arm code, applicant-defined group code, group label, set label, dose level and units, control type, and planned number of males and females for each set.

tx.xpt

tx.xpt

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery1ARMCDArm Code01
2TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery2SPGRPCDapplicant-Defined Group Code1
3TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery3GRPLBLGroup LabelGroup 1, Control
4TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery4SETLBLSet LabelGroup 1, Control - Nonrec
5TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery5TRTDOSDose Level0
6TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery6TRTDOSUDose Unitsmg/kg/day
7TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery7TCNTRLControl TypeVEHICLE CONTROL
8TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery8PLANMSUBPlanned Number of Male Subjects5
9TDM1TX1NRControl Group, Vehicle Control once daily, Nonrecovery9PLANFSUBPlanned Number of Female Subjects5
10TDM1TX1RControl Group, Vehicle Control once daily, Recovery10ARMCDArm Code01R
11TDM1TX1RControl Group, Vehicle Control once daily, Recovery11SPGRPCDApplicant-Defined Group Code1
12TDM1TX1RControl Group, Vehicle Control once daily, Recovery12GRPLBLGroup LabelGroup 1, Control
13TDM1TX1RControl Group, Vehicle Control once daily, Recovery13SETLBLSet LabelGroup 1, Control - Rec
14TDM1TX1RControl Group, Vehicle Control once daily, Recovery14TRTDOSDose Level0
15TDM1TX1RControl Group, Vehicle Control once daily, Recovery15TRTDOSUDose Unitsmg/kg/day
16TDM1TX1RControl Group, Vehicle Control once daily, Recovery16TCNTRLControl TypeVEHICLE CONTROL
17TDM1TX1RControl Group, Vehicle Control once daily, Recovery17PLANMSUBPlanned Number of Male Subjects5
18TDM1TX1RControl Group, Vehicle Control once daily, Recovery18PLANFSUBPlanned Number of Female Subjects5
19TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery19ARMCDArm Code02
20TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery20SPGRPCDApplicant-Defined Group Code2
21TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery21GRPLBLGroup LabelGroup 2, 100 mg/kg
22TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery22SETLBLSet LabelGroup 2, 100 mg/kg - Nonrec
23TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery23TRTDOSDose Level100
24TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery24TRTDOSUDose Unitsmg/kg/day
25TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery25PLANMSUBPlanned Number of Male Subjects5
26TDM1TX2NRLow-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery26PLANFSUBPlanned Number of Female Subjects5
27TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery27ARMCDArm Code02R
28TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery28SPGRPCDApplicant-Defined Group Code2
29TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery29GRPLBLGroup LabelGroup 2, 100 mg/kg
30TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery30SETLBLSet LabelGroup 2, 100 mg/kg - Rec
31TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery31TRTDOSDose Level100
32TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery32TRTDOSUDose Unitsmg/kg/day
33TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery33PLANMSUBPlanned Number of Male Subjects5
34TDM1TX2RLow-Dose Group, 100 mg/kg Drug a once daily, Recovery34PLANFSUBPlanned Number of Female Subjects5
35TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery35ARMCDArm Code03
36TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery36SPGRPCDApplicant-Defined Group Code3
37TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery37GRPLBLGroup LabelGroup 3, 500 mg/kg
38TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery38SETLBLSet LabelGroup 3, 500 mg/kg - Nonrec
39TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery39TRTDOSDose Level500
40TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery40TRTDOSUDose Unitsmg/kg/day
41TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery41PLANMSUBPlanned Number of Male Subjects5
42TDM1TX3NRHigh-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery42PLANFSUBPlanned Number of Female Subjects5
43TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery43ARMCDArm Code03R
44TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery44SPGRPCDApplicant-Defined Group Code3
45TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery45GRPLBLGroup LabelGroup 3, 500 mg/kg
46TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery46SETLBLSet LabelGroup 3, 500 mg/kg - Rec
47TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery47TRTDOSDose Level500
48TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery48TRTDOSUDose Unitsmg/kg/day
49TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery49PLANMSUBPlanned Number of Male Subjects5
50TDM1TX3RHigh-Dose Group, 500 mg/kg Drug a once daily, Recovery50PLANFSUBPlanned Number of Female Subjects5
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