How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology

Emanuel Krebs; Deirdre Weymann; Tania Bubela; Dean A Regier

doi:10.3389/fmed.2025.1563950

How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology

Front Med (Lausanne). 2025 Sep 2:12:1563950. doi: 10.3389/fmed.2025.1563950. eCollection 2025.

Authors

Emanuel Krebs^#¹, Deirdre Weymann^#^{1

2}, Tania Bubela^{2

3}, Dean A Regier^{1

4}

Affiliations

¹ Regulatory Science Lab, BC Cancer Research Institute, Vancouver, BC, Canada.
² Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada.
³ Aga Khan University, Karachi, Pakistan.
⁴ School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.

^# Contributed equally.

Abstract

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: causal inference; decision making; life-cycle assessment; precision oncology; real-world data (RWD); real-world evidence (RWE); regulatory acceptance and use; regulatory science.