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Motivation• Sunitinib trial (from Blay,2010)• Big treatment effect onprogression-free survival• Many in placebo arm“switched” to receivesunitinib after progression• No treatment effect onoverall survival (except invery early follow-up)• How can we analyse suchdata?• More later from Xin Huang2
Note on terminology• I’ve called this workshop “Methods for handlingtreatment switching …”• Others use “treatment cross-overs” – but may led toconfusion with cross-over trials?• Links to wider statistical literature on “non-compliance”– where I’d prefer the non-judgemental “departuresfrom randomised treatment”3
Page 1: Methods for handling treatmentswitc
Page 5 and 6: Plan of the dayIan WhiteSusie DoddJ
Page 7 and 8: Defining the question• What is th
Page 9 and 10: A hypothetical (& simplistic) trial
Page 11 and 12: Intention-To-Treat (ITT) Analysis
Page 13 and 14: Per Protocol (PP) Analysis• Censo
Page 15 and 16: Inverse-probability-of-censoring we
Page 17 and 18: Inverse probability weights• Half
Page 19 and 20: Choice of covariates for IPCW• Re
Page 21 and 22: Note on IPCW• Can handle more tha
Page 23 and 24: Marginal Structural Models (MSMs)
Page 25 and 26: Towards the RPSFTM• focussing on
Page 27 and 28: RPSFTM (2)• The RPSFTM relates ob
Page 29 and 30: Interpretation of ψModel: T i (0)
Page 31 and 32: G-estimation: an unusual estimation
Page 33 and 34: Hypothetical data(switches occur on
Page 35 and 36: Estimating ψ: is e ψ = 0.5?Treate
Page 37 and 38: Censoring• Censoring introduces c
Page 39 and 40: Non-standard RPSFTM-like analysisto
Page 41 and 42: Arguments used: IPCWFor• Gives HR
Page 43 and 44: Key messages: design• Collect fol
Page 45 and 46: Summary & questions• IPCW, MSM an

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