Journal of Biopharmaceutical Statistics

Article	Citations
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	24
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f 2	24
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	24
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	17
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	15
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	13
A stochastically curtailed single‐arm phase II trial design for binary outcomes	12
Optimised point estimators for multi-stage single-arm phase II oncology trials	12
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	11
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	11
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	11
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	11
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	10
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	10
Estimand in benefit-risk assessment	10
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	9
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	9
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	9
A shrinkage estimator for subgroup analysis without the exchangeability assumption	9
Whole-cage randomization for animal studies with unequal cage or group sizes	8
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	8
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	7
Evaluating bias control strategies in observational studies using frequentist model averaging	7
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	7
Statistical innovation for next generation pharmaceutical development	7

A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	7
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	7
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	7
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	7
Calibrated dynamic borrowing using capping priors	6
Defining optimal cut-off points for multiple class ROC analysis: generalization of the Index of Union method	6
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	6
Machine learning approach for detection of MACE events within clinical trial data	6
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	6
Strategies for successful dose optimization in oncology drug development: a practical guide	6
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	6
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	6
Evaluating bias in the anchor method for the minimal clinically important difference: a simulation approach	6
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	5
Optimal designs for phase II clinical trials with heterogeneous patient populations	5
Analysis of continuous monitoring device data	5
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	5
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	5
Sequential monitoring of cancer immunotherapy trial with random delayed treatment effect	5
FDA experiences with a centralized statistical monitoring tool	5
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	5
Comparison of continuous, binary, and ordinal endpoints	5
Adjusted win ratio using the inverse probability of treatment weighting	5
Double machine learning methods for estimating average treatment effects: a comparative study	5
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	4
Bayesian censored piecewise regression mixture models with skewness	4
Conditional power in vaccine trials with seasonal variations	4
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study	4
Using Bayesian hierarchical models for controlled post hoc subgroup analysis of clinical trials: application to smoking cessation treatment in American Indians and Alaska Natives	4
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	4
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	4
Sample size determination for a study with variable follow-up time	4
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	4
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	4
Bayesian method for comparing F1 scores in the absence of a gold standard	4
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data	4
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	4
Bayesian screening for feature selection	4
Guest editors’ note on special issue on application of estimand	4
Combination MCP-Mod for two-drug combination dose-ranging studies	4
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	4
The use of real-world data for clinical investigation of effectiveness in drug development	4
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	4
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	4
Isotonic design for phase I cancer clinical trials with late-onset toxicities	3
The impact of different data handling strategies in exploratory and confirmatory factor analysis of diary measures: an evaluation using simulated and real-world asthma nighttime symptoms diary data	3
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Real world data (RWD) in pediatrics	3

Dynamic incorporation of real world evidence within the framework of adaptive design	3
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Assessment of nonlinear dose–response relationships via nonparametric regression	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	3
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	3
Emerging insights and commentaries – MMRM vs LOCF	3
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	3
Adaptive two-stage seamless sequential design for clinical trials	3
Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	3
Establishment of RWS guidance reflecting contributions of China to regulatory science	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	3
Random intercept hierarchical linear model for multi-regional clinical trials	3
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	3
On F β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Estimation of the selected treatment mean in two stage drop-the-losers design	2
Bayesian design of clinical trials using the scale transformed power prior	2
Informative event rate in study determination, study design, and interim analysis monitoring with non-proportional hazards	2
Assessing model accuracy using random data split: a simulation study	2
Meta-analysis application to hERG safety evaluation in clinical trials	2
Identifying the clinical relative importance of each correlated outcome variables in multivariate approach: an exploration using ACCORD trial data	2
Use of alternative and confirmatory data in support of rare disease drug development	2
Addressing sequential and concurrent treatment regimens in a small n sequential, multiple assignment, randomized trial (snSMART) in the MISTIC study	2
A randomized Bayesian optimal phase II design with binary endpoint	2
Statistical considerations for using tolerance interval to set product specification for normally distributed attribute	2
Developing large language models to detect adverse drug events in posts on x	2
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	2
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups	2
Response to Comment on “Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	2
Flexible parametric accelerated failure time model	2
Novel machine learning approach to differential cell flow cytometry analysis based on projection pursuit	2
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	2
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	2
Reimagining optimization of clinical trials efficiency through use of statistical innovation, technology and non-standard data sources	2
Generalized triple outcome decision-making in basket trials	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
The value of a two-armed Bayesian response adaptive randomization trial	2
Comparing diagnostic tests and biomarkers based on benefit-risk under tree orderings of disease classes	2
Estimation of treatment effects in early phase randomized clinical trials involving multiple data sources for external control	2
Correction	2
Estimation of treatment effects in early-phase randomized clinical trials involving external control data	2
Bayesian analyses of multiple random change points in survival models with applications to clinical trials	2
An improved biomarker-guided adaptive patient enrichment design for oncology trials	2
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials	2
Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials	2
Investigating the impact of data monitoring committee recommendations on the probability of trial success	2
The role of regulatory flexibility in the review and approval process of rare disease drug development	2
Reverse graphical approaches for multiple test procedures	1
Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>	1
Covariate-adjusted value-guided subgroup identification via boosting	1
Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data	1
Saddlepoint approximation for weighted log-rank tests based on block truncated binomial design	1
Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	1
Simultaneous comparison of the predictive values of two binary diagnostic tests in the presence of categorical covariates	1
Applied Meta-Analysis with R and Stata, 2nd Edition	1
Dissecting the restricted mean time in favor of treatment	1
Response to comment on “Transporting survival of an HIV clinical trial to the external target populations by Lee et al. (2024)”	1
Direct estimation of volume under the ROC surface with verification bias	1
Optimal two-phase sampling for comparing correlated areas under the ROC curves of two screening tests in the presence of verification bias	1
Bayesian model averaging of longitudinal dose-response models	1
Statistical operating characteristics of current early phase dose finding designs with toxicity and efficacy in oncology	1
Correction	1
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	1
Miettinen and Nurminen score statistics revisited	1
Group sequential designs for cancer immunotherapy trial with delayed treatment effect	1
Improving power in adaptive expansion of biomarker populations in phase 3 clinical trials	1
Overview of real-world applications of federated learning with NVIDIA FLARE	1
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	1
Interval estimation of relative risks for combined unilateral and bilateral correlated data	1
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials	1
Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life	1
Mitigating propensity score model misspecification with multiply robust weights when leveraging external data	1
Joint linear and nonlinear mixed effects model with random change points for left-censored longitudinal data: application to HIV surveillance	1
Defective regression models for cure rate data with competing risks	1
Response to Comment on ‘Statistical Consideration and Challenges in Bridging Study of Personalized Medicine’: A modified variance for sensitivity	1

Robust estimates of regional treatment effects in multiregional randomized clinical trials with ordinal responses	1
Bayesian design of clinical trials with multiple time-to-event outcomes subject to functional cure	1
A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	1
Efficient estimation of the cox model when incorporating the subgroup restricted mean survival time	1
Two-stage response adaptive randomization designs for multi-arm trials with binary outcome	1
Adaptive promising zone design for cancer immunotherapy with heterogeneous delayed treatment effect	1
Correction	1
Bayesian hierarchical model for dose-finding trial incorporating historical data	1
A novel approach to augment single-arm clinical studies with real-world data	1
A promising subgroup identification method based on a genetic algorithm for censored survival data	1
Multi-arm multi-stage survival trial design with arm-specific stopping rule	1
Assess predictive values of a binary diagnostic test under a nested case–control design	1
Large-scale dependent multiple testing via higher-order hidden Markov models	1
Inverse probability weighted Bayesian dynamic borrowing for estimation of marginal treatment effects with application to hybrid control arm oncology studies	1
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources	1
Sample size reestimation and Bayesian predictive probability for single-arm clinical trials with a time-to-event endpoint using Weibull distribution with unknown shape parameter	1
Transporting survival of an HIV clinical trial to the external target populations	1
Approximate Bayesian estimation of time to clinical benefit using Frequentist approaches: an application to an intensive blood pressure control trial	1
Optimal dose selection in phase I/II dose finding trial with contextual bandits: a case study and practical recommendations	1
A multiple imputation approach in enhancing causal inference for overall survival in randomized controlled trials with crossover	1
Comments on ”Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	1
Bias and Type I error Control in Correcting Treatment Effect for Treatment Switching Using Marginal Structural Models in Phase III Oncology Trials	1
Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves	1
DOD-BART: machine learning-based dose optimization design incorporating patient-level prognostic factors via Bayesian additive regression trees	1
A composite semiparametric homogeneity test for the distributions of multigroup interval-bounded longitudinal data	1
Bayesian optimal Phase II survival trial design with event-driven approach	1
Epistemic uncertainty in Bayesian predictive probabilities	1
Statistical learning in preclinical drug proarrhythmic assessment	1
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	1
On a Holm-related MTP for rejecting at least k hypotheses: general validity, optimality property, confidence regions, and applications	1
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	1
Determining the late effect parameter in the Fleming-Harrington test using asymptotic relative efficiency in cancer immunotherapy clinical trials	1