11 papers
Frequentist-calibrated Bayesian group sequential design with dynamic borrowing
Francesco Mariani, Shirin Golchi, Stefania Gubbiotti +1
Bayesian analysis is increasingly used in clinical trials. However, assessment of the design with respect to the frequentist operating characteristics, such as type I error and pow…
Group Sequential Design with Posterior and Posterior Predictive Probabilities
Luke Hagar, Shirin Golchi, Marina B. Klein
Group sequential designs drive innovation in clinical, industrial, and corporate settings. Early stopping for failure in sequential designs conserves experimental resources, wherea…
A Bayesian adaptive enrichment design using aggregate historical data to inform individualized treatment recommendations
Lara Maleyeff, Shirin Golchi, Erica E. M. Moodie
Adaptive enrichment trials aim to identify and recruit participants most likely to benefit from treatment based on evolving biomarker evidence, with the goal of informing individua…
Bayesian Design and Analysis of Precision Trials with Partial Borrowing
Shirin Golchi, Satoshi Morita
With the advancement of precision medicine there is an increasing need for design and analysis methods in clinical trials with the objective of investigating effect heterogeneity a…
Identifying Treatment Effect Heterogeneity with Bayesian Hierarchical Adjustable Random Partition in Adaptive Enrichment Trials
Xianglin Zhao, Shirin Golchi, Jean-Philippe Gouin +1
Treatment effect heterogeneity refers to the systematic variation in treatment effects across subgroups. There is an increasing need for clinical trials that aim to investigate tre…
Design of Bayesian Clinical Trials with Clustered Data
Luke Hagar, Shirin Golchi
In the design of clinical trials, it is essential to assess the design operating characteristics (e.g., power and the type I error rate). Common practice for the evaluation of oper…