Evidence for personalised medicine: mechanisms, correlation, and new kinds of black box

Mary Jean Walker*, Justin Bourke, Katrina Hutchison

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)


Personalised medicine (PM) has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells (iPSCs) so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system.

Original languageEnglish
Pages (from-to)103-121
Number of pages19
JournalTheoretical Medicine and Bioethics
Issue number2
Publication statusPublished - Apr 2019


  • Black box
  • Correlational evidence
  • Induced pluripotent stem cell
  • Mechanistic evidence
  • Personalised medicine


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