112 citations · 264 across the 17 of their papers we have counts for
8 papers · 1 filter
Learning from Literature: Integrating LLMs and Bayesian Hierarchical Modeling for Oncology Trial Design
Guannan Gong, Satrajit Roychoudhury, Allison Meisner +3
Designing modern oncology trials requires synthesizing evidence from prior studies to inform hypothesis generation and sample size determination. Trial designs based on incomplete…
On fixed and uncertain mixture prior weights
Beat Neuenschwander, Simon Wandel, Satrajit Roychoudhury +1
This paper focuses on the specification of the weights for the components of mixture priors.
The Predictive Individual Effect for Survival Data
Beat Neuenschwander, Satrajit Roychoudhury, Simon Wandel +2
The call for patient-focused drug development is loud and clear, as expressed in the 21st Century Cures Act and in recent guidelines and initiatives of regulatory agencies. Among t…
Principal Stratum Strategy: Potential Role in Drug Development
Björn Bornkamp, Kaspar Rufibach, Jianchang Lin +6
A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristi…
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…