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Censoring Bias in Oncology Clinical Trials

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Author

  • Andrea Mattsson

Summary, in English

Time to disease progression or death (PFS) is of main interest in oncology clinical trials. The data is commonly analyzed using a Cox model. Early discontinuation gives uncertainty in the estimated hazard ratio (HR). Censoring is generally used to handle discontinuations. However, if discontinuations are related to the patients’ prognosis, the HR may be biased. By simulating PFS data, this bias was investigated. The direction and size of the bias is dependent on the proportion of censored patients in each treatment arm. Our results show that supplementary analyses with different strategies to handle discontinuation should be used to compare cancer treatments.

Publishing year

2020

Language

English

Publication/Series

Bachelor's Theses in Mathematical Sciences

Document type

Student publication for Bachelor's degree

Topic

  • Mathematics and Statistics

Keywords

  • survival analysis
  • censoring
  • progression-free survival
  • Cox proportional hazards model
  • oncology clinical trial
  • HER2CLIMB

Report number

LUNFMS-4046-2020

Supervisor

  • Anna Lindgren
  • Aldana Rosso

Scientific presentation

ISBN/ISSN/Other

  • ISSN: 1654-6229
  • 2020:K16