Excitement about the dramatic increase in potential successful anticancer medicines in recent years is hampered by the high costs involved as well as the length of time traditional pathways take for regulatory approval. The translation of experimental clinical data into real-world evidence is also problematic. While the randomised controlled trial remains the gold standard for assessing efficacy and safety, there is increasing interest in the use of observational data to enable more rapid, informed and widespread availability and access to important anticancer medicines. Taking real-world evidence into account in regulatory and health technology assessment in a thoughtful and balanced fashion will enrich and justify sound decision-making.

Original languageEnglish
Pages (from-to)69-76
Number of pages8
JournalEuropean Journal of Cancer
Publication statusPublished - Sept 2018


  • Drug development
  • Cancer
  • Clinical trials
  • Real-world data
  • Regulatory approval


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