The Trial Without Walls: How Real-World Evidence Is Rewriting the Rules of Drug Approval

Real-world evidence (RWE) from routine clinical practice can now substitute for traditional randomised control arms in drug trials through trial emulation methodology, but FDA and ICH guidance remains incomplete on disease-specific thresholds and data quality standards. Sponsors are redesigning Phase 3 programs mid-cycle to exploit this regulatory shift, though underlying real-world data quality—not methodology—remains the critical barrier to approval.

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