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Table 3 Impact of variable factors on STAMPEDE target accrual and duration

From: Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial

  Median Arms accruing at stage Total Differences in
Pts/yr Median FFS (m) Median OS (m) 1 2 3 4 Pts Time (m) Total pts Time (m)
Reference
500 24 48 6 6 6 6 3411 82 0 0
Impact of accrual rate
350 24 48 6 6 6 6 2960 102 -451 20
500 24 48 6 6 6 6 3411 82 0 0
750 24 48 6 6 6 6 4046 65 635 -17
Impact of FFS event rates
500 18 36 6 6 6 6 3040 73 -371 -9
500 24 48 6 6 6 6 3411 82 0 0
500 30 60 6 6 6 6 3743 90 332 8
Impact of OS event rates
500 24 48 6 6 6 6 3411 82 0 0
500 24 60 6 6 6 6 3743 90 332 8
Impact of dropping arms
500 24 48 6 6 6 6 3411 82 0 0
500 24 48 6 6 6 2 3190 77 -221 -5
500 24 48 6 6 2 2 2983 72 -428 -10
500 24 48 6 2 2 2 2738 66 -673 -16
500 24 48 6 5 4 3 3133 75 -278 -7
  1. Difference = difference from reference scenario, FFS = failure-free survival, OS = overall survival, Pts = patients, M = months. This does not include the Pilot stage for safety, concentrating only the particular issues relating to the application of the MAMS activity and efficacy stages