<p>Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidisciplinary think tank was established to further advance acceptance and use of RWE in treatment decision-making, with the focus on breast cancer (while recognizing relevance in oncology more broadly). Members discussed perceptions of RWE from a clinical perspective, across domains of data, methodology, and mindset, and “calls-to-action” for stakeholders. Agreement was reached on a primary “call-to-action,” to develop clinically-relevant, patient-informed, real-world endpoints, and secondary “calls-to-action”: establish a multidisciplinary consensus forum; publish examples of unique RWE value; build upon existing frameworks and resources; and tailor an approach for exhibiting utility to guideline bodies.</p>

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Real-World Evidence Acceptability and Use in Breast Cancer Treatment Decision-Making in the United States: Call-to-Action from a Multidisciplinary Think Tank

  • Sean Khozin,
  • Nancy A. Dreyer,
  • Dominic Galante,
  • Raymond Liu,
  • Peter Neumann,
  • Nathan Nussbaum,
  • Joyce O’Shaughnessy,
  • Debra Patt,
  • Mothaffar Rimawi,
  • Hope Rugo,
  • Sara M. Tolaney,
  • Marisa Weiss,
  • Adam Brufsky

摘要

Complementing randomized controlled trials, real-world evidence (RWE) from observational analyses can extend clinical insights in oncology. While healthcare stakeholders have published rigorous RWE frameworks and resources, a multidisciplinary think tank was established to further advance acceptance and use of RWE in treatment decision-making, with the focus on breast cancer (while recognizing relevance in oncology more broadly). Members discussed perceptions of RWE from a clinical perspective, across domains of data, methodology, and mindset, and “calls-to-action” for stakeholders. Agreement was reached on a primary “call-to-action,” to develop clinically-relevant, patient-informed, real-world endpoints, and secondary “calls-to-action”: establish a multidisciplinary consensus forum; publish examples of unique RWE value; build upon existing frameworks and resources; and tailor an approach for exhibiting utility to guideline bodies.