112 citations · 114 across the 5 of their papers we have counts for
5 papers
A gated group sequential design for seamless Phase II/III trial with subpopulation selection
Guanhong Miao, Jason J. Z. Liao, Jing Yang +1
Due to the high cost and high failure rate of Phase III trials, seamless Phase II/III designs are more and more popular to trial efficiency. A potential attraction of Phase II/III…
A unified framework for weighted parametric group sequential design (WPGSD)
Keaven M. Anderson, Zifang Guo, Jing Zhao +1
Group sequential design (GSD) is widely used in clinical trials in which correlated tests of multiple hypotheses are used. Multiple primary objectives resulting in tests with known…
Multiplicity for a Group Sequential Trial with Biomarker Subpopulations
Ting-Yu Chen, Jing Zhao, Linda Sun +1
Biomarker subpopulations have become increasingly important for drug development in targeted therapies. The use of biomarkers has the potential to facilitate more effective outcome…
Alternative Analysis Methods for Time to Event Endpoints under Non-proportional Hazards: A Comparative Analysis
Ray S. Lin, Ji Lin, Satrajit Roychoudhury +16
The log-rank test is most powerful under proportional hazards (PH). In practice, non-PH patterns are often observed in clinical trials, such as in immuno-oncology; therefore, alter…
Robust Design and Analysis of Clinical Trials With Non-proportional Hazards: A Straw Man Guidance from a Cross-pharma Working Group
Satrajit Roychoudhury, Keaven M Anderson, Jiabu Ye +1
Loss of power and clear description of treatment differences are key issues in designing and analyzing a clinical trial where non-proportional hazard is a possibility. A log-rank t…