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Across 2025–2026’s highest-profile oncology setbacks, the underlying science was frequently sound. The trial design was not. This whitepaper examines three distinct Phase 2/3 failures — population mismatch, enrollment infeasibility, and endpoint misalignment — and proposes a clinically grounded, AI-augmented framework for patient-first trial design. Draws on the published biomarker-stratification evidence base, disease-specific response assessment standards (RECIST, Lugano, RANO, ELN), and current FDA/EMA AI guidance.
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