112 citations · 264 across the 17 of their papers we have counts for
17 papers
CARB: A Covariate-Assessed Robust Borrowing Strategy with Literature-Informed Prior Weights for External Data
Jinping Liang, Guannan Gong, Satrajit Roychoudhury +1
Borrowing external control data can improve the efficiency of clinical trials, particularly when patient accrual is difficult. A persistent challenge is how to prespecify the degre…
Dynamic Prediction of the Target Survival Time in Metastatic Solid Tumor Cancer Clinical Trials
Sidi Wang, Kelley Kidwell, Bo Huang +1
Overall survival (OS) is the gold standard for assessing patient benefit and cost-effectiveness of new cancer drugs. However, it is often difficult to use OS as the primary endpoin…
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 regional treatment effect assessment using robust MAP priors
Xin Zhang, Hui Zhang, Satrajit Roychoudhury
Bayesian dynamic borrowing has become an increasingly important tool for evaluating the consistency of regional treatment effects which is a key requirement for local regulatory ap…
Evaluating treatment effects on longitudinal outcomes with attrition due to death: Methods for a two-dimentional estimand with a case study in Quality of Life
Dries Reynders, Doranne Thomassen, Satrajit Roychoudhury +5
When longitudinal outcomes are evaluated in mortal populations, their non-existence after death complicates the analysis and its causal interpretation. Where popular methods often…
A robust score test in g-computation for covariate adjustment in randomized clinical trials leveraging different variance estimators via influence functions
Xin Zhang, Haitao Chu, Lin Liu +1
G-computation has become a widely used robust method for estimating unconditional (marginal) treatment effects with covariate adjustment in the analysis of randomized clinical tria…
Study Duration Prediction for Clinical Trials with Time-to-Event Endpoints Using Mixture Distributions Accounting for Heterogeneous Population
Hong Zhang, Jie Pu, Shibing Deng +3
In the era of precision medicine, more and more clinical trials are now driven or guided by biomarkers, which are patient characteristics objectively measured and evaluated as indi…
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.
Duration of and time to response in oncology clinical trials from the perspective of the estimand framework
Hans-Jochen Weber, Stephen Corson, Jiang Li +6
Duration of response (DOR) and time to response (TTR) are typically evaluated as secondary endpoints in early-stage clinical studies in oncology when efficacy is assessed by the be…
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…
Estimands in Hematologic Oncology Trials
Steven Sun, Hans-Jochen Weber, Emily Butler +2
The estimand framework included in the addendum to the ICH E9 guideline facilitates discussions to ensure alignment between the key question of interest, the analysis, and interpre…
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…
On the structure of a family of probability generating functions induced by shock models
Satrajit Roychoudhury, Manish C. Bhattacharjee
We explore conditions for a class of functions defined via an integral representation to be a probability generating function of some positive integer valued random variable. Inter…