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ECA
Reliable ECAs cut enrollment in half, dramatically accelerating development of treatments for high-unmet need conditions.
External Controls to Study Treatment Effects in Rare Diseases: Challenges and Future Directions
Review Article
Single-arm oncology trials and the nature of external controls arms
Paper
A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases
Review Article
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
Paper
Considerations for pooling real-world data as a comparator cohort to a single arm trial: a simulation study on assessment of heterogeneity
Paper
Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers
Review Article
