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When control-arm patients switch to the new drug after their cancer grows, the survival comparison gets muddied. Trials should plan in advance how they will correct for this, and report both raw and corrected numbers.
Protocols permitting treatment switching pre-specify the adjustment method (rank-preserving structural failure time, inverse probability of censoring weighting, two-stage estimation), the assumptions, and sensitivity analyses, with the estimand defined under ICH E9(R1). Both intention-to-treat and adjusted OS are reported in the label and in HTA submissions. Health technology agencies already require this ad hoc; the idea is to make it a registration requirement.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Hazard ratio (HR), Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Overall survival (OS), Trial design, endpoints and cost.
Shares European Society for Medical Oncology (ESMO), Hazard ratio (HR), Overall survival (OS), Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.
Shares European Society for Medical Oncology (ESMO), Hazard ratio (HR), Trial design, endpoints and cost.
Shares Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13, Trial design, endpoints and cost.