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

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Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

FDA

Real-world evidence to support regulatory submissions: A landscape review and assessment of use cases

CTS-Key

Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions

CPT

Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls

CPT

External control arms in oncology: current use and future directions

AoO

Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development

FiO

A Comparison of 7 Oncology External Control Arm Case Studies: Critiques From Regulatory and Health Technology Assessment Agencies

ViH ISPOR

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