Example: Simple Parallel Design, No Recovery

This example assumes a simple parallel 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.
  • 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.
  • 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.

There are no other experimental factors of interest specified in the study design. There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the applicant has chosen to provide a small amount of additional information about each trial set, including the associated arm code, applicant-defined protocol group number, control group type, group label, and dose level and units, and the applicant has made the assumption that male and female animals will be compared separately when relevant.

tx.xpt

tx.xpt

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1EXP1TX1Control Group, Vehicle Control once daily1ARMCDArm Code1
2EXP1TX1Control Group, Vehicle Control once daily2SPGRPCDApplicant-Defined Group Code1
3EXP1TX1Control Group, Vehicle Control once daily3TCNTRLControl TypeVEHICLE CONTROL
4EXP1TX1Control Group, Vehicle Control once daily4GRPLBLGroup LabelGroup 1, Control
5EXP1TX1Control Group, Vehicle Control once daily5TRTDOSDose Level0
6EXP1TX1Control Group, Vehicle Control once daily6TRTDOSUDose Unitsmg/kg/day
7EXP1TX2Low-Dose Group, 100 mg/kg Drug a once daily7ARMCDArm Code2
8EXP1TX2Low-Dose Group, 100 mg/kg Drug a once daily8SPGRPCDApplicant-Defined Group Code2
9EXP1TX2Low-Dose Group, 100 mg/kg Drug a once daily9GRPLBLGroup LabelGroup 2, 100 mg/kg/day
10EXP1TX2Low-Dose Group, 100 mg/kg Drug a once daily10TRTDOSDose Level100
11EXP1TX2Low-Dose Group, 100 mg/kg Drug a once daily11TRTDOSUDose Unitsmg/kg/day
12EXP1TX3High-Dose Group, 500 mg/kg Drug a once daily12ARMCDArm Code3
13EXP1TX3High-Dose Group, 500 mg/kg Drug a once daily13SPGRPCDApplicant-Defined Group Code3
14EXP1TX3High-Dose Group, 500 mg/kg Drug a once daily14GRPLBLGroup LabelGroup 3, 500 mg/kg/day
15EXP1TX3High-Dose Group, 500 mg/kg Drug a once daily15TRTDOSDose Level500
16EXP1TX3High-Dose Group, 500 mg/kg Drug a once daily16TRTDOSUDose Unitsmg/kg/day
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See also Section 3.2.1.5, Additional Examples of In Vivo Trial Designs.

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