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Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection.

Cynthia HuberTim FriedeJulia StinglNorbert Benda
Published in: Therapeutic innovation & regulatory science (2021)
The proposed classification will facilitate regulatory decision-making and support drug development with respect to biomarker-related subgrouping, both, during clinical programme and at the time of marketing authorization application, since the grade of evidence on the differential power of the biomarker can be considered as an indicator for the usefulness of a biomarker-related subgrouping.
Keyphrases
  • machine learning
  • decision making
  • deep learning
  • randomized controlled trial
  • clinical trial
  • transcription factor