Robust safety monitoring and signal detection using alternatives to the standard poisson distribution

2024-9-11

Optimum designs for clinical trials in personalized medicine when response variance depends on treatment

2024-8-31

MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design

2024-8-29

Strategies for successful dose optimization in oncology drug development: a practical guide

2024-8-11

Up-front matching: an ongoing recruitment method for prospective observational studies that mimics randomization for selected baseline covariates

2024-7-22

Leveraging pharmacokinetic parameters as covariate in Bayesian logistic regression model to optimize dose selection in early phase oncology trial

2024-7-19

The score-goldilocks design for phase 3 clinical trials

2024-7-12

A constrained optimum adaptive design for dose finding in early phase clinical trials

2024-7-10

Response to comment on “Transporting survival of an HIV clinical trial to the external target populations by Lee et al. (2024)”

2024-7-8

Re: Transporting survival of an HIV clinical trial to the external target populations

2024-6-29

The generalized order statistics arising from three populations with the lower truncated proportional hazard rate models and its application to the sensitivity to the early disease stage

2024-6-22

Pharmacometrics-Enabled DOse OPtimization (PEDOOP) for seamless phase I-II trials in oncology

2024-6-18

Clustering plasma concentration-time curves: applications of unsupervised learning in pharmacogenomics

2024-6-18

A comparison of Bayesian and score methods for interval estimates of positive/negative likelihood ratios in support of diagnostic device performance evaluation

2024-6-18

Drug safety assessment by machine learning models

2024-6-18

Meta-analysis application to hERG safety evaluation in clinical trials

2024-6-14

Optimal two-phase sampling for comparing correlated areas under the ROC curves of two screening tests in the presence of verification bias

2024-6-13

PROpwr: a Shiny R application to analyze patient-reported outcomes data and estimate power

2024-6-13

Investigating pharmacokinetic profiles of <i>Centella asiatica</i> using machine learning and PBPK modelling

2024-6-11

A machine learning case study to predict rare clinical event of interest: imbalanced data, interpretability, and practical considerations

2024-6-11

Saddlepoint p-values for a class of location-scale tests

2024-6-10

Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift

2024-6-7

Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design

2024-6-6

Application of estimand framework to the design and analysis of multi-regional clinical trials

2024-6-5

Improved automated spot counting and modeling with bias correction

2024-6-5

Biomarker-driven basket trial designs: origins and new methodological developments

2024-6-4

A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics

2024-5-30

Adaptive two-stage seamless sequential design for clinical trials

2024-5-5

Statistical methods to control for confounders in rare disease settings that use external control

2024-5-2

[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes

2024-4-30

An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment

2024-4-23

Bayesian design of clinical trials using the scale transformed power prior

2024-4-19

Utility of real-world evidence in biosimilar development

2024-4-17

Adaptive sequential design for phase II single-arm oncology trials: an expansion of Simon’s design

2024-4-15

Adaptive promising zone design for cancer immunotherapy with heterogeneous delayed treatment effect

2024-4-14

P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data

2024-4-14

Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves

2024-4-14

genRCT: a statistical analysis framework for generalizing RCT findings to real-world population

2024-4-8

An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data

2024-4-5

Regional consistency assessment in multiregional clinical trials

2024-4-1

Optimization of EWOC principle in BLRM design for phase 1 oncology trials

2024-4-1

Adaptively leverage multiple real-world data sources for treatment effect estimation based on similarity

2024-4-1

Covariate adjusted meta-analytic predictive (CA-MAP) prior for historical borrowing using patient-level data

2024-4-1

Empower clinical development by harnessing data from diverse sources: methodology, applications and regulatory perspectives

2024-4-1

Estimating treatment effect in randomized trial after control to treatment crossover using external controls

2024-4-1

FDA experiences with a centralized statistical monitoring tool

2024-3-29

Flexible seamless 2-in-1 design with sample size adaptation

2024-3-29

Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study

2024-3-29

Transporting survival of an HIV clinical trial to the external target populations

2024-3-23

Assessing clinical response in early oncology development with a predictive biomarker

2024-3-22