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Analyzing patient-reported outcome data when completion differs between arms in open-label trials: an application of principal stratification.

Jessica K RoydhouseRoee GutmanVishal BhatnagarPaul G KluetzRajeshwari SridharaPallavi S Mishra-Kalyani
Published in: Pharmacoepidemiology and drug safety (2019)
The principal stratification estimand may be a useful additional analysis, especially if PRO completion differs between arms.
Keyphrases
  • patient reported outcomes
  • open label
  • clinical trial
  • electronic health record
  • big data
  • study protocol
  • anti inflammatory
  • phase ii study
  • phase iii
  • squamous cell carcinoma
  • machine learning
  • data analysis