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October 3, 2025Journal of Comparative Effectiveness Research3 citationsOpen Access

R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 21

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PAPaul AroraSRSreeram V Ramagopalan

Key Points

  • The vocal adoption of the target trial emulation framework by the US FDA suggests proactive engagement in health assessments.
  • Key frameworks like the FRAME methodology systematically evaluate the use and impact of real-world evidence in regulatory submissions.
  • The Canadian CanREValue framework is crucial for improving cancer medicine reassessment decisions with real-world evidence.
  • Recent developments indicate a significant shift towards leveraging real-world evidence to enhance decision-making in health technology assessments.

Abstract

In this update, we explore the vocal adoption of the target trial emulation framework by the US FDA, the FRAME methodology for systematically evaluating the use and impact of RWE in health technology assessment and regulatory submissions, and the Canadian CanREValue framework for incorporating RWE into cancer medicine reassessment decisions.

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Cite This Study

Arora et al. (2025) studied this question.

synapsesocial.com/papers/68e02f34f0e39f13e7fa2299https://doi.org/10.57264/cer-2025-0148
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