Journal of Biopharmaceutical Statistics

Article	Citations
Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data	32
The inverse-probability-of-censoring weighting (IPCW) adjusted win ratio statistic: an unbiased estimator in the presence of independent censoring	26
Comparison of propensity score methods for pre-specified subgroup analysis with survival data	18
Bayesian Semi-parametric Design (BSD) for adaptive dose-finding with multiple strata	17
Precise and accurate power of the rank-sum test for a continuous outcome	14
Multiplicity issues for platform trials with a shared control arm	12
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	12
Incorporating propensity scores for evidence synthesis under bayesian framework: review and recommendations for clinical studies	12
The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations	10
TEPI-2 and UBI: designs for optimal immuno-oncology and cell therapy dose finding with toxicity and efficacy	9
Log-rank tests for censored clustered data under generalized randomized block design: Saddlepoint approximation	9
The use of the win odds in the design of non-inferiority clinical trials	8
A BAYESIAN ADAPTIVE TWO-STAGE DESIGN FOR PEDIATRIC CLINICAL TRIALS	8
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	8
Futility stopping in clinical trials, optimality and practical considerations	7
Using supervised machine learning approach to predict treatment outcomes of vedolizumab in ulcerative colitis patients	7
Weighted log-rank tests for left-truncated data under Wei’s urn design: saddlepoint p-values and confidence intervals	7
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	7
A simulation study of approaches for handling disease progression in dose-finding clinical trials	7
Two-stage optimal designs based on exact variance for a single-arm trial with survival endpoints	6
Matching design for augmenting the control arm of a randomized controlled trial using real-world data	6
Design optimization for dose-finding trials: a review	6
Dose-finding design and benchmark for a right censored endpoint	6
Dynamic borrowing from a single prior data source using the conditional power prior	6
Restricted mean survival time and confidence intervals by empirical likelihood ratio	6

Subgroup analysis based on structured mixed-effects models for longitudinal data	6
A novel approach to augment single-arm clinical studies with real-world data	6
Confidence intervals for the Youden index and its optimal cut-off point in the presence of covariates	6
Leverage multiple real-world data sources in single-arm medical device clinical studies	5
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	5
Bayesian joint modeling for partially linear mixed-effects quantile regression of longitudinal and time-to-event data with limit of detection, covariate measurement errors and skewness	5
Statistical and practical considerations in designing of immuno-oncology trials	5
Tests for equivalence of two survival functions: alternatives to the PH and PO models	5
Bayesian sample size determination in a three-arm non-inferiority trial with binary endpoints	5
Evaluating bias control strategies in observational studies using frequentist model averaging	5
P-values and confidence intervals of linear rank tests for left-truncated data under truncated binomial design	4
Evidence inconsistency degrees of freedom in Bayesian network meta-analysis	4
Randomized two-stage optimal design for interval-censored data	4
Two-tailed asymptotic inferences for the odds ratio in cross-sectional studies: evaluation of fifteen old and new methods of inference	4
Exact critical values for group sequential designs with small sample sizes	4
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	4
Bayesian Additive Regression Trees (BART) with covariate adjusted borrowing in subgroup analyses	4
Multi-stage adaptive enrichment trial design with subgroup estimation	4
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer	4
The win odds: statistical inference and regression	4
A new basket trial design based on clustering of homogeneous subpopulations	4
Checkerboard: a Bayesian efficacy and toxicity interval design for phase I/II dose-finding trials	4
Analysis of time-to-event data using a flexible mixture model under a constraint of proportional hazards	4
Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges	3
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	3
A nonparametric approach to confidence intervals for concordance index and difference between correlated indices	3
On dependence assumption in p-value based multiple test procedures	3
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	3
A curve similarity approach to parallelism testing in bioassay	3
Optimal biological dose selection in dose-finding trials with model-assisted designs based on efficacy and toxicity: a simulation study	3
Power calculations for the sequential parallel comparison design with continuous outcomes	3
Evaluating medical device adverse event signals using a likelihood ratio test method	3
Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	3
Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study	3
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	3
Sample size determination for Bayesian analysis of small n sequential, multiple assignment, randomized trials (snSMARTs) with three agents	3
A year in review: artificial intelligence permeates into mainstream statistics in pharmaceutical product development at a laggard pace	3
Perspectives on informative Bayesian methods in pediatrics	3
Matching within a hybrid RCT/RWD: framework on associated causal estimands	3
Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data	3
Evidence synthesis analysis with prioritized benefit outcomes in oncology clinical trials	3
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f 2	3
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	3
Challenges and potential strategies utilizing external data for efficacy evaluation in small-sized clinical trials	3
Pair copula construction for longitudinal data with zero-inflated power series marginal distributions	3
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials	3
Bayesian joint modeling of ordinal longitudinal measurements and competing risks survival data for analysing Tehran Lipid and Glucose Study	3
Flexible parametric accelerated failure time model	3
Estimand in benefit-risk assessment	2
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	2

Modelling non-linear patterns of time-varying intervention effects on recurrent events in infectious disease prevention studies	2
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
Forecasting determinants of recurrence in lung cancer patients exploiting various machine learning models	2
A stochastically curtailed single‐arm phase II trial design for binary outcomes	2
Comparison of statistical methodologies used to estimate the treatment effect on time-to-event outcomes in observational studies	2
The Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials	2
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	2
Advancing drug development in pediatric oncology, a focus on cancer biology and targeted therapies: iMATRIX platform	2
Investigation of the relationship between heart rate and functional class in pulmonary hypertension	2
Practical guidance on modeling choices for the virtual twins method	2
Functional modeling of pedaling kinematics for the Stroke patients	2
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data	2
A Cholesky-based sparse covariance estimation with an application to genes data	2
How to select the initial dose for a pediatric study?	2
Estimation on conditional restricted mean survival time with counting process	2
Application of a likelihood ratio test based method for safety signal detection to left ventricular assist devices	2
Recommended confidence intervals for the conditional odds ratio in matched-pairs designs	2
Measuring individual benefits of psychiatric treatment using longitudinal binary outcomes: Application to antipsychotic benefits in non-cannabis and cannabis users	2
Weighted log-rank tests for censored data under Wei’s urn design: saddlepoint approximation and confidence intervals	2
A collection of parametric modal regression models for bounded data	2
Parameter estimation of Weibull distribution for the number of days between drug administration and early onset adverse event	2
Assessing model accuracy using random data split: a simulation study	2
Inclusion of unexposed subjects improves the precision and power of self-controlled case series method	2
Nonparametric inference of the area under ROC curve under two-phase cluster sampling	2
Randomization tests in clinical trials with multiple imputation for handling missing data	2
Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment	2
Equivalence tests under the Cox-Aalen model and the partly Aalen model	2
A win ratio approach for comparing crossing survival curves in clinical trials	2
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	2
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	2
Estimation of the area under a curve via several B-spline-based regression methods and applications	2
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	2
Estimands and estimators of two-level methods using return to baseline strategy for longitudinal clinical trials with incomplete daily patient reported outcomes	2
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	2
Fast QLB algorithm and hypothesis tests in logistic model for ophthalmologic bilateral correlated data	2
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	2
Two-stage response adaptive randomization designs for multi-arm trials with binary outcome	2
Testing the homogeneity of proportions for combined unilateral and bilateral data	2
Utility of propensity score-based Bayesian borrowing of external adult data in pediatric trials: A pragmatic evaluation through a case study in acute lymphoblastic leukemia (ALL)	2
Construction of a survival tree for dependent censoring	1
Special Issue PRO-Analysis of Clinically Meaningful Change on Patient-Reported Outcomes: Renewed Insights About Covariate Adjustment	1
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials	1
A new type of generalized information criterion for regularization parameter selection in penalized regression with application to treatment process data	1
Optimal designs for phase II clinical trials with heterogeneous patient populations	1
Reverse graphical approaches for multiple test procedures	1
Composite Likelihoods with Bounded Weights in Extrapolation of Data	1
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	1
Robust estimates of regional treatment effects in multiregional randomized clinical trials with ordinal responses	1
Application of estimand framework in ICH E9 (R1) to vaccine trials	1
A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	1
Baseline selection in concentration-QTc modeling: impact on assay sensitivity	1
Response to letter to editor	1
Sample size calculation using Markov chains for a one-arm study of heroin administration routes	1
Statistical learning in preclinical drug proarrhythmic assessment	1
Dynamic incorporation of real world evidence within the framework of adaptive design	1
On Reference-based Imputation for Analysis of Incomplete Repeated Binary Endpoints	1
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	1
Optimised point estimators for multi-stage single-arm phase II oncology trials	1
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources	1
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	1
Networked knowledge, combinatorial creativity, and (statistical) innovation	1
Multi-stage dose expansion cohort (MSDEC) design with Bayesian stopping rule	1
Calibrated dynamic borrowing using capping priors	1
Guest Editors’ Note on the Special Issue Real-World Evidence	1
Saddlepoint approximation for weighted log-rank tests based on block truncated binomial design	1
Multi-arm multi-stage clinical trials for time-to-event outcomes	1
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials	1
RESTART trial design: two-stage seamless transition design with operational considerations	1
Confidence interval construction for proportion difference from partially validated series with two fallible classifiers	1
A two-stage approach for joint modeling of longitudinal measurements and competing risks data	1
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	1
Empirical weighted Bayesian tolerance intervals	1
Study design for a three-arm equivalence clinical trial with binomially distributed outcomes	1
Bayesian Divide-and-Conquer Propensity Score Based Approaches for Leveraging Real World Data in Single Arm Clinical Trials	1
Estimation of the selected treatment mean in two stage drop-the-losers design	1
Do strict decision criteria hamper productivity in the pharmaceutical industry?	1
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	1
Relative efficiency of equal versus unequal cluster sizes in cluster randomized trials with a small number of clusters	1
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	1

Adjusted win ratio using the inverse probability of treatment weighting	1
Joint model for longitudinal mixture of normal and zero-inflated power series correlated responses Abbreviated title:mixture of normal and zero-inflated power series random-effects model	1
An optimal response adaptive design for multi-treatment clinical trials with ordinal categorical outcomes	1
Borrowing historical information to improve phase I clinical trials using meta-analytic-predictive priors	1
Enhancing clarity of clinical trial safety reports for data monitoring committees	1
Use of a tolerance interval approach as a statistical quality control tool for traditional Chinese medicine	1
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic	1
Adaptive platform trials: the impact of common controls on type one error and power	1
Letter to the editor: Inconsistencies between example data and calculation results in Bland, J. M., & Altman, D. G. (2007). Agreement between methods of measurement with multiple observations per	1
Beyond p < .05: a critical review of new Bayesian proposals for assessing the p-value	1
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	1
Statistics and machine learning methods for EHR data – from data extraction to data analytics	1
Modified Goldilocks Design with strict type I error control in confirmatory clinical trials	1
Response adaptive randomization design for a two-stage study with binary response	1
Homogeneity test of several covariance matrices with high-dimensional data	1
Reflections on estimands for patient-reported outcomes in cancer clinical trials	1
Clinical trial considerations for pediatric cancer drug development	1
Real world data (RWD) in pediatrics	1
Emerging insights and commentaries – MMRM vs LOCF	1
Application of estimand framework in ICH E9 (R1) to safety evaluation	1