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

Area of Science:

• Oncology
• Health Services Research
• Biotechnology

Background:

• Precision oncology, utilizing omics-based diagnostics for histology-agnostic cancer treatment, faces implementation barriers.
• High uncertainty in regulatory and reimbursement evidence submissions limits widespread adoption of precision oncology.

Purpose of the Study:

• To describe a life-cycle evaluation approach for precision oncology technologies.
• To address evidentiary uncertainty using real-world evidence (RWE).
• To guide regulatory and reimbursement decision-making.

Main Methods:

• The study proposes a framework grounded in RWE derived from routinely collected healthcare data.
• It reviews biases in observational precision oncology evaluations.
• Recommendations for RWE study design, analysis, and data collection are provided.

Main Results:

• Real-world data (RWD) can support the generation of decision-grade RWE.
• This approach enables real-world life-cycle assessment for precision oncology technologies.
• The framework aims to reduce uncertainty in evidence submissions.

Conclusions:

• A life-cycle approach utilizing RWE is crucial for evaluating precision oncology technologies.
• Standardized data collection and robust RWE methodologies are needed.
• This strategy can facilitate the integration of precision oncology into healthcare systems.