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Table 1 Timeline of events from trial opening to adding the new arms

From: A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia

Date Task
Q3 2014 Stage 1 open to recruitment September 2014: FCR vs IR
Q3 2015 Emerging response data for venetoclax
FLAIR recruiting ahead of target
Decision to progress amendment
Q4 2015 Initial DMEC/TSC review and provisional approval
CRUK amendment application
AbbVie funding application
NCRI CSG review
Q1 2016 AbbVie agreed to support amendment subject to contract
Q2 2016 CRUK approval
Janssen agreed to support amendment subject to contract
Protocol amendments began
Q1 2017 Amendments to protocol and PIS finalised
DMEC/TSC final approval
MHRA substantial amendments submitted
Q2 2017 Ethics substantial amendments submitted
Preliminary safety data for I+V became available
CRFs and database amendments finalised
Contracts signed and all approvals had been received
Q3 2017 Stage 2 open to recruitment: FCR vs IR vs I vs I+V
Amendment randomisation became live July 2017
Original randomisation system switched off August 2017