PERSPECTIVE article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1563950
How Life-Cycle Real-World Evidence Can Bridge Evidentiary Gaps in Precision Oncology
Provisionally accepted
- 1BC Cancer Research Institute, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
- 2Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada
- 3Aga Khan University, Karachi, Sindh, Pakistan
- 4University of British Columbia, Vancouver, British Columbia, Canada
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Precision oncology uses omics-based diagnostic technologies to inform histology-agnostic cancer treatment. To date, health system implementation remains limited owing to high uncertainty in regulatory and reimbursement evidence submissions. In this perspective, we describe a life-cycle approach to the evaluation of precision oncology technologies that addresses evidentiary uncertainty and is grounded in real-world evidence (RWE) derived using data routinely collected by healthcare systems. We consider the role for RWE in international regulatory and reimbursement decision-making, review common biases for observational precision oncology evaluations, make specific recommendations for RWE study design and analysis, and specify healthcare system requirements for data collection. We then explore how decision-grade real-world data can support the generation of decision-grade RWE, ultimately enabling real-world life-cycle assessment for precision oncology.
Keywords: Real-world evidence (RWE), real-world data (RWD), Life-cycle a ssessment, causal inference, Regulatory Science, Decision Making, Regulatory acceptance and use, precision oncology
Received: 20 Jan 2025; Accepted: 31 Jul 2025.
Copyright: © 2025 Krebs, Weymann, Bubela and Regier. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dean Regier, BC Cancer Research Institute, Faculty of Medicine, University of British Columbia, Vancouver, V5Z 1L3, British Columbia, Canada
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.