4 papers · 1 filter
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…
Beyond p-values: a phase II dual-criterion design with statistical significance and clinical relevance
Satrajit Roychoudhury, Nicolas Scheuer, Beat Neuenschwander
Background: Well-designed phase II trials must have acceptable error rates relative to a pre-specified success criterion, usually a statistically significant p-value. Such standard…
Bayesian leveraging of historical control data for a clinical trial with time-to-event endpoint
Satrajit Roychoudhury, Beat Neuenschwander
The recent 21st Century Cures Act propagates innovations to accelerate the discovery, development, and delivery of 21st century cures. It includes the broader application of Bayesi…
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…