Artificial intelligence (AI) and real-world evidence (RWE) are playing a growing role across oncology development—from patient stratification and trial design to post-approval monitoring. As adoption accelerates, regulators are setting clearer expectations to ensure these tools are applied with transparency, rigor, and accountability.
This white paper explores how global agencies, including the FDA, EMA, MHRA, and Health Canada, are aligning around shared principles for responsible AI and RWE use. It outlines practical considerations to help sponsors generate credible, high-quality oncology evidence while meeting evolving regulatory expectations.
What’s Inside
- How AI and RWE are being applied across the oncology lifecycle
- Key regulatory perspectives shaping validation, governance, and oversight
- Practical use cases supporting trial design and evidence generation
- Operational considerations for data integrity, bias mitigation, and lifecycle monitoring
Download the White Paper
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