2 papers
stat.ME2025
Designing Efficient Hybrid and Single-Arm Trials: External Control Borrowing and Sample Size Calculation
Yujing Gao, Xiang Zhang, Shu Yang
External controls (ECs) from historical trials or real-world data have gained increasing attention as a way to augment hybrid and single-arm trials, especially when balanced random…
stat.ME2025
Doubly robust omnibus sensitivity analysis of externally controlled trials with intercurrent events
Chenyin Gao, Xiang Zhang, Shu Yang
Externally controlled trials are crucial in clinical development when randomized controlled trials are unethical or impractical. These trials consist of a full treatment arm with t…