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Updated: Apr 23, 2026

Establishing a Competing Risk Regression Nomogram Model for Survival Data
Published on: October 23, 2020
Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation
Linus Jönsson1, Rickard Sandin2, Mattias Ekman1
1OptumInsight AB, Klarabergsviadukten, Stockholm, Sweden.
Correcting for treatment crossover in oncology trials is crucial for accurate survival and cost-effectiveness analysis. Choosing appropriate statistical methods, like inverse probability of censoring weighting or rank-preserving structural failure time models, minimizes bias and ensures optimal drug reimbursement decisions.
Area of Science:
- Clinical Trials Methodology
- Health Economics
- Oncology Research
Background:
- Patient crossover to active treatment in oncology trials is common for ethical reasons.
- Crossover complicates overall survival and cost-effectiveness analyses due to information loss and diluted efficacy.
Purpose of the Study:
- To review methods for addressing crossover in clinical trial analysis.
- To assess the impact of crossover on survival estimates and cost-effectiveness.
- To examine how crossover influences reimbursement decisions.
Main Methods:
- Literature review of statistical methods for crossover adjustment.
- Analysis of health technology assessment decisions in oncology.
- Illustration using two phase III sunitinib oncology trials.
Main Results:
- Statistical method choice significantly impacts treatment effect and cost-effectiveness estimates when crossover is high.
- Inverse probability of censoring weighting or rank-preserving structural failure time models are recommended for frequent crossover.
- Method selection depends on crossover characteristics, trial size, and data availability.
Conclusions:
- Failure to adjust for crossover can lead to poor reimbursement decisions.
- Accurate analysis ensures effective drugs reach patients and are appropriately valued.
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