Pre-specified crossover-adjusted survival in every trial that allows crossover
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.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
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not linked directly; found by shared links- IdeaBayesian shrinkage for subgroup claims to stop false 'works in this group' stories
- IdeaAgree in advance how to borrow evidence between similar rare cancers
Shares Hazard ratio (HR), European Society for Medical Oncology (ESMO), Trial design, endpoints and cost.
- IdeaPower trials to detect a benefit patients would value, not the smallest detectable one
Shares Hazard ratio (HR), European Society for Medical Oncology (ESMO), Overall survival (OS), Trial design, endpoints and cost.
- IdeaQuality-adjusted survival reported in every trial publication and label
Shares Hazard ratio (HR), Overall survival (OS).
- IdeaSeamless phase 2/3 with pre-registered go rules as the default for new agents
Shares Overall survival (OS), Trial design, endpoints and cost.
- IdeaRandomise the next line of treatment before the first one fails
Shares Overall survival (OS), Trial design, endpoints and cost.
- PersonMichael LeBlanc
Shares Hazard ratio (HR), Overall survival (OS).
- IdeaWin-ratio endpoints that weigh survival, toxicity and quality of life together
Shares European Society for Medical Oncology (ESMO), Overall survival (OS), Trial design, endpoints and cost.