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ECA
Reliable ECAs cut enrollment in half, dramatically accelerating development of treatments for high-unmet need conditions.
Real-world evidence (RWE) to reduce the size and duration of clinical trials
Blog Post
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
Guidance
Real-world evidence to support regulatory submissions: A landscape review and assessment of use cases
Review Article
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions
Review Article
Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls
Review Article
External control arms in oncology: current use and future directions
Review Article
Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development
Review Article
A Comparison of 7 Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies
Paper
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