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Paper
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility
Semi-supervised mixture multi-source exchangeability model for leveraging real-world data in clinical trials
Considerations for pooling real-world data as a comparator cohort to a single arm trial: a simulation study on assessment of heterogeneity
On the relevance of prognostic information for clinical trials: A theoretical quantification
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Minimizing control group allocation in randomized trials using dynamic borrowing of external control data – An application to second line therapy for non-small cell lung cancer