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Scope of the problemMany trials have not just treatment switching (i.e. to thetreatment allocated to the other trial arm), but also:• Other changes of prescribed treatment– changes to non-trial treatments– changes to no treatment– multiple treatments– dose adjustment• Non-compliance with prescribed treatment4
Plan of the dayIan WhiteSusie DoddJames MordenNick LatimerNeil HawkinsXin HuangRobHemmingsMartin Pitt &Martin HoyleClaire WatkinsChris MetcalfeMethods for handling treatment switching: rank-preservingstructural nested failure time models, inverse-probability-ofcensoringweighting, and marginal structural modelsDeparture from treatment protocol in published RCTs: a reviewMethods for adjusting survival estimates in the presence oftreatment crossover – simulation studiesMethods for health economic models in metastatic cancerAdjusting the Crossover Effect in Survival Analysis Using aRank Preserving Structural Failure Time Model: The Case ofSunitinib GIST TrialTreatment switches in cancer trials – problems, pitfalls and(no) solutionsDealing with treatment switches in cost-effectiveness analysis:the NICE experienceDiscussants & general discussion5
Page 1 and 2: Methods for handling treatmentswitc
Page 3: Note on terminology• I’ve calle
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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