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Paper
A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real-World Evidence for Regulatory Decisions
A Simulation-Based Evaluation of Statistical Methods for Hybrid Real-World Control Arms in Clinical Trials
Single-arm oncology trials and the nature of external controls arms
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation
Covariate adjustment in Bayesian adaptive randomized controlled trials
The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework
Comparative Study of Bayesian Information Borrowing Methods in Oncology Clinical Trials
Covariate-adjusted borrowing of historical control data in randomized clinical trials
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