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

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.