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	25
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	15
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	14
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	14
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f 2	13
Optimised point estimators for multi-stage single-arm phase II oncology trials	12
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	12
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	11
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	11
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	11
A stochastically curtailed single‐arm phase II trial design for binary outcomes	11
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	10
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	10
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	9
Whole-cage randomization for animal studies with unequal cage or group sizes	9
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	8
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	8
A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	8
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	8
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	8
Estimand in benefit-risk assessment	8
Evaluating bias in the anchor method for the minimal clinically important difference: a simulation approach	7
Statistical innovation for next generation pharmaceutical development	7
Machine learning approach for detection of MACE events within clinical trial data	7
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	7

An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	7
Enhancing dose selection in phase I cancer trials: Extending the Bayesian Logistic Regression Model with non-DLT adverse events integration	7
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	7
Evaluating bias control strategies in observational studies using frequentist model averaging	7
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	6
Optimal designs for phase II clinical trials with heterogeneous patient populations	6
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	6
Adjusted win ratio using the inverse probability of treatment weighting	6
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	6
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	6
Defining optimal cut-off points for multiple class ROC analysis: generalization of the Index of Union method	6
Bayesian censored piecewise regression mixture models with skewness	5
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	5
Strategies for successful dose optimization in oncology drug development: a practical guide	5
Comparison of continuous, binary, and ordinal endpoints	5
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	5
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	5
Guest editors’ note on special issue on application of estimand	5
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	5
Sequential monitoring of cancer immunotherapy trial with random delayed treatment effect	5
Bayesian screening for feature selection	5
FDA experiences with a centralized statistical monitoring tool	5
Double machine learning methods for estimating average treatment effects: a comparative study	5
Sample size determination for a study with variable follow-up time	5
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	5
Analysis of continuous monitoring device data	5
Linear regression models for analyzing the covariate-adjusted Youden index and associated cut-off points in three diagnostic groups	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	5
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	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
Recovery of overall survival information from treatment switching in oncology trials using multiple imputation	4
Bayesian method for comparing F1 scores in the absence of a gold standard	4
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	4
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	4
Combination MCP-Mod for two-drug combination dose-ranging studies	4
Isotonic design for phase I cancer clinical trials with late-onset toxicities	4
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	4
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	4
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	4
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	4
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	4
Conditional power in vaccine trials with seasonal variations	4
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	4
The use of real-world data for clinical investigation of effectiveness in drug development	4
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data	4
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	4
Establishment of RWS guidance reflecting contributions of China to regulatory science	3
BOP2-FE: Bayesian optimal phase II design with futility and efficacy-stopping boundaries	3
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3

Adaptive two-stage seamless sequential design for clinical trials	3
Assessment of nonlinear dose–response relationships via nonparametric regression	3
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	3
Real world data (RWD) in pediatrics	3
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	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
On F β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3
Change-point detection in Weibull-accelerated failure time models via narrowest significance pursuit	3
Emerging insights and commentaries – MMRM vs LOCF	3
Dynamic incorporation of real world evidence within the framework of adaptive design	3
Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	3
Common risk difference and corresponding confidence interval adjusted for multiple factors – comparison of seven different methods	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Reimagining optimization of clinical trials efficiency through use of statistical innovation, technology and non-standard data sources	2
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
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	2
Generalized triple outcome decision-making in basket trials	2
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	2
Use of alternative and confirmatory data in support of rare disease drug development	2
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups	2
Novel machine learning approach to differential cell flow cytometry analysis based on projection pursuit	2
Response to Comment on “Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	2
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	2
Estimation of treatment effects in early phase randomized clinical trials involving multiple data sources for external control	2
Comparing diagnostic tests and biomarkers based on benefit-risk under tree orderings of disease classes	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
Correction	2
Investigating the impact of data monitoring committee recommendations on the probability of trial success	2
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials	2
Developing large language models to detect adverse drug events in posts on x	2
Assessing model accuracy using random data split: a simulation study	2
Meta-analysis application to hERG safety evaluation in clinical trials	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
Bayesian design of clinical trials using the scale transformed power prior	2
The value of a two-armed Bayesian response adaptive randomization trial	2
Determining the late effect parameter in the Fleming-Harrington test using asymptotic relative efficiency in cancer immunotherapy clinical trials	2
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials	2
The role of regulatory flexibility in the review and approval process of rare disease drug development	2
Statistical considerations for using tolerance interval to set product specification for normally distributed attribute	2
Estimation of the selected treatment mean in two stage drop-the-losers design	2
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	2
Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>	2
Correction	2
An improved biomarker-guided adaptive patient enrichment design for oncology trials	2
Informative event rate in study determination, study design, and interim analysis monitoring with non-proportional hazards	2
Identifying the clinical relative importance of each correlated outcome variables in multivariate approach: an exploration using ACCORD trial data	2
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	2
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
Overview of real-world applications of federated learning with NVIDIA FLARE	1
Statistical operating characteristics of current early phase dose finding designs with toxicity and efficacy in oncology	1
Reverse graphical approaches for multiple test procedures	1
Simultaneous comparison of the predictive values of two binary diagnostic tests in the presence of categorical covariates	1
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	1
Statistical learning in preclinical drug proarrhythmic assessment	1
Joint linear and nonlinear mixed effects model with random change points for left-censored longitudinal data: application to HIV surveillance	1
Inverse probability weighted Bayesian dynamic borrowing for estimation of marginal treatment effects with application to hybrid control arm oncology studies	1
Miettinen and Nurminen score statistics revisited	1
A promising subgroup identification method based on a genetic algorithm for censored survival data	1
A multiple imputation approach in enhancing causal inference for overall survival in randomized controlled trials with crossover	1
Power priors and type I error control: constrained borrowing of external control data	1
Application of marginal structural models for causal inference on the treatment effect for overall survival in randomized controlled trials with control arm patients switching to active intervention a	1
Reweighting estimators to extend the external validity of clinical trials: methodological considerations	1
Drug safety assessment by machine learning models	1
Comments on ”Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	1
Robust estimates of regional treatment effects in multiregional randomized clinical trials with ordinal responses	1
Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves	1
Bayesian hierarchical model for dose-finding trial incorporating historical data	1
Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data	1
A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	1
A bias correction method for hazard ratio estimation and its inference in a multiple-arm clinical trial	1
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources	1
Response to Comment on ‘Statistical Consideration and Challenges in Bridging Study of Personalized Medicine’: A modified variance for sensitivity	1

Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	1
Adaptive promising zone design for cancer immunotherapy with heterogeneous delayed treatment effect	1
Applied Meta-Analysis with R and Stata, 2nd Edition	1
Group sequential designs for cancer immunotherapy trial with delayed treatment effect	1
Direct estimation of volume under the ROC surface with verification bias	1
Optimal dose selection in phase I/II dose finding trial with contextual bandits: a case study and practical recommendations	1
Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life	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
Interval estimation of relative risks for combined unilateral and bilateral correlated data	1
Multi-stage dose expansion cohort (MSDEC) design with Bayesian stopping rule	1
Multi-armed bandits backfill Bayesian optimal interval design	1
Issues in cox proportional hazards model with unequal randomization	1
Bayesian design of clinical trials with multiple time-to-event outcomes subject to functional cure	1
Defective regression models for cure rate data with competing risks	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
Transporting survival of an HIV clinical trial to the external target populations	1
TITE-STEIN: Time-to-event simple toxicity and efficacy interval design to accelerate phase I/II trials	1
Improving power in adaptive expansion of biomarker populations in phase 3 clinical trials	1
The proportional treatment effect: A metric that empowers and connects	1
Covariate-adjusted value-guided subgroup identification via boosting	1
On a Holm-related MTP for rejecting at least k hypotheses: general validity, optimality property, confidence regions, and applications	1
Efficient estimation of the cox model when incorporating the subgroup restricted mean survival time	1
Correction	1
Demystifying stabilization in inverse probability of treatment weighting	1
Epistemic uncertainty in Bayesian predictive probabilities	1
Bias and Type I error Control in Correcting Treatment Effect for Treatment Switching Using Marginal Structural Models in Phase III Oncology Trials	1
Statistical approaches to evaluate the positive control drug using the hERG assay	1
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	1
Multi-arm multi-stage survival trial design with arm-specific stopping rule	1
Bayesian optimal Phase II survival trial design with event-driven approach	1
Large-scale dependent multiple testing via higher-order hidden Markov models	1
A Bayesian three-tier quantitative decision-making framework for single arm studies in early phase oncology	1
Saddlepoint approximation for weighted log-rank tests based on block truncated binomial design	1
Approximate Bayesian estimation of time to clinical benefit using Frequentist approaches: an application to an intensive blood pressure control trial	1
Two-stage response adaptive randomization designs for multi-arm trials with binary outcome	1
Assessing predictive probability of success for future clinical trials	1
Response to comment on “Transporting survival of an HIV clinical trial to the external target populations by Lee et al. (2024)”	1
Dissecting the restricted mean time in favor of treatment	1
Mitigating propensity score model misspecification with multiply robust weights when leveraging external data	1