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Table 2 Planned actions and timelines when accrual is stopped to trial arms

From: Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Action required Timelines
  Safety LOB
Notify sites in writing of IDMC meeting date to pre-warn -28 d -28 d
Circulate prior letter from regulatory agency confirming that stopping early for LOB is not a substantial amendment, but part of trial design -28 d -28 d
IDMC meeting -7 d -7 d
IDMC notes and recommendations finalised (<1 w) (<1 w)
TSC meeting: stop / continue decision for each research arm Day 0 Day 0
Turn off randomisation to arms stopping early for safety <24 h <1 w
Notify centres by email; patients to ignore irrelevant parts of PIS <24 h <24 h
Notify relevant industry partners <24 h <24 h
Notify TMG members <24 h <24 h
Alert trials unit staff to potential queries <24 h <48 h
Phone all site PIs. Instructed to hand-amend PIS and CF. Updated documentation to follow <1 w <1 w
Protocol and documents updated and agreed by TMG <1 w <1 w
Summary information for patients <2 w <2 w
Notify ethics committee and regulatory agency (for information only) <2 w <2 w
Detailed discussions with industry partners <1 m <1 m
TMG review of processes <1 m <1 m
  1. Key: LOB = lack-of-benefit; IDMC = Independent Data Monitoring Committee; TSC = Trial Steering Committee; TMG = Trial Management Group; PIS = patient information sheet; CF = consent form; h = hour; w = week.
  2. Note: the observed timelines broadly followed these plans.