Example: Simple Parallel Design, No Recovery

TOBA-211 - Getting issue details... STATUS TOBA-212 - Getting issue details... STATUS 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. In this case, the design consists of 3 trial arms, because there are 3 distinct sequences of elements, depicted as follows:

TOBA-210 - Getting issue details... STATUS

ta.xpt

ta.xpt

RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1EXP1TA1Control1SCRNScreenRandomized to Group 1PRE-EXPOSURE
2EXP1TA1Control2TRT01Vehicle Control
EXPOSURE
3EXP1TA2100 mg/kg1SCRNScreenRandomized to Group 2PRE-EXPOSURE
4EXP1TA2100 mg/kg2TRT02100 mg/kg Drug A
EXPOSURE
5EXP1TA3500 mg/kg1SCRNScreenRandomized to Group 3PRE-EXPOSURE
6EXP1TA3500 mg/kg2TRT03500 mg/kg Drug A
EXPOSURE
$warningHtml

  • No labels