Journal of Biopharmaceutical Statistics

Article	Citations
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	14
Incorporating propensity scores for evidence synthesis under bayesian framework: review and recommendations for clinical studies	13
Log-rank tests for censored clustered data under generalized randomized block design: Saddlepoint approximation	10
Evaluating bias control strategies in observational studies using frequentist model averaging	10
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	10
Using supervised machine learning approach to predict treatment outcomes of vedolizumab in ulcerative colitis patients	9
Weighted log-rank tests for left-truncated data under Wei’s urn design: saddlepoint p-values and confidence intervals	9
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	9
Leverage multiple real-world data sources in single-arm medical device clinical studies	9
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	9
A novel approach to augment single-arm clinical studies with real-world data	8
Dose-finding design and benchmark for a right censored endpoint	8
Matching design for augmenting the control arm of a randomized controlled trial using real-world data	7
Dynamic borrowing from a single prior data source using the conditional power prior	7
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	6
A new basket trial design based on clustering of homogeneous subpopulations	6
Flexible parametric accelerated failure time model	6
Evidence synthesis analysis with prioritized benefit outcomes in oncology clinical trials	6
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	6
Restricted mean survival time and confidence intervals by empirical likelihood ratio	6
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer	6
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	5
Evidence inconsistency degrees of freedom in Bayesian network meta-analysis	5
The win odds: statistical inference and regression	5
Bayesian Additive Regression Trees (BART) with covariate adjusted borrowing in subgroup analyses	5

Parameter estimation of Weibull distribution for the number of days between drug administration and early onset adverse event	5
Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study	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
Bayesian sample size determination in a three-arm non-inferiority trial with binary endpoints	5
Perspectives on informative Bayesian methods in pediatrics	5
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	5
P-values and confidence intervals of linear rank tests for left-truncated data under truncated binomial design	5
A year in review: artificial intelligence permeates into mainstream statistics in pharmaceutical product development at a laggard pace	5
Randomized two-stage optimal design for interval-censored data	5
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	4
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials	4
Practical guidance on modeling choices for the virtual twins method	4
A nonparametric approach to confidence intervals for concordance index and difference between correlated indices	4
A collection of parametric modal regression models for bounded data	4
Matching within a hybrid RCT/RWD: framework on associated causal estimands	4
Application of estimand framework in ICH E9 (R1) to vaccine trials	4
The Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials	4
Application of estimand framework in ICH E9 (R1) to safety evaluation	4
Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data	4
Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment	4
Forecasting determinants of recurrence in lung cancer patients exploiting various machine learning models	4
Real world data (RWD) in pediatrics	3
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	3
Recommended confidence intervals for the conditional odds ratio in matched-pairs designs	3
Isotonic design for phase I cancer clinical trials with late-onset toxicities	3
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	3
Flexible seamless 2-in-1 design with sample size adaptation	3
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	3
Calibrated dynamic borrowing using capping priors	3
Optimal biological dose selection in dose-finding trials with model-assisted designs based on efficacy and toxicity: a simulation study	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	3
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	3
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f 2	3
On dependence assumption in p-value based multiple test procedures	3
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	3
Generalized exponentiated unit Gompertz distribution for modeling arthritic pain relief times data: classical approach to statistical inference	3
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	3
Adjusted win ratio using the inverse probability of treatment weighting	3
Transporting survival of an HIV clinical trial to the external target populations	3
Dynamic incorporation of real world evidence within the framework of adaptive design	3
Estimand in benefit-risk assessment	3
Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	3
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics	3
Weighted log-rank tests for censored data under Wei’s urn design: saddlepoint approximation and confidence intervals	3
Modelling non-linear patterns of time-varying intervention effects on recurrent events in infectious disease prevention studies	3
Challenges and potential strategies utilizing external data for efficacy evaluation in small-sized clinical trials	3
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	3
Optimal designs for phase II clinical trials with heterogeneous patient populations	3

Assessing model accuracy using random data split: a simulation study	3
Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges	3
Testing the homogeneity of proportions for combined unilateral and bilateral data	3
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources	2
Reflections on estimands for patient-reported outcomes in cancer clinical trials	2
Advancing drug development in pediatric oncology, a focus on cancer biology and targeted therapies: iMATRIX platform	2
Randomization tests in clinical trials with multiple imputation for handling missing data	2
How to select the initial dose for a pediatric study?	2
Adaptive platform trials: the impact of common controls on type one error and power	2
Beyond p < .05: a critical review of new Bayesian proposals for assessing the p-value	2
A two-stage approach for joint modeling of longitudinal measurements and competing risks data	2
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic	2
Reweighting estimators to extend the external validity of clinical trials: methodological considerations	2
The value of a two-armed Bayesian response adaptive randomization trial	2
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	2
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	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
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	2
A Cholesky-based sparse covariance estimation with an application to genes data	2
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	2
[Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework	2
Statistics and machine learning methods for EHR data – from data extraction to data analytics	2
Comparison of statistical methodologies used to estimate the treatment effect on time-to-event outcomes in observational studies	2
Saddlepoint approximation for weighted log-rank tests based on block truncated binomial design	2
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	2
Fast tipping point sensitivity analyses in clinical trials with missing continuous outcomes under multiple imputation	2
Group sequential multi-arm multi-stage survival trial design with treatment selection	2
Investigation of the relationship between heart rate and functional class in pulmonary hypertension	2
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data	2
Mixed-effects models for censored data with autoregressive errors	2
Inclusion of unexposed subjects improves the precision and power of self-controlled case series method	2
Estimands and estimators of two-level methods using return to baseline strategy for longitudinal clinical trials with incomplete daily patient reported outcomes	2
Two-stage response adaptive randomization designs for multi-arm trials with binary outcome	2
Nonparametric inference of the area under ROC curve under two-phase cluster sampling	2
Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	2
Clinical trial considerations for pediatric cancer drug development	2
Special Issue PRO-Analysis of Clinically Meaningful Change on Patient-Reported Outcomes: Renewed Insights About Covariate Adjustment	1
Utilizing stratified generalized propensity score matching to approximate blocked randomized designs with multiple treatment levels	1
Prediction of vedolizumab treatment outcomes by machine learning	1
Bayesian Divide-and-Conquer Propensity Score Based Approaches for Leveraging Real World Data in Single Arm Clinical Trials	1
Composite Likelihoods with Bounded Weights in Extrapolation of Data	1
Adaptive two-stage seamless sequential design for clinical trials	1
Confidence interval construction for proportion difference from partially validated series with two fallible classifiers	1
Emerging insights and commentaries – MMRM vs LOCF	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
Optimised point estimators for multi-stage single-arm phase II oncology trials	1
Study design for a three-arm equivalence clinical trial with binomially distributed outcomes	1
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	1
Estimation of the selected treatment mean in two stage drop-the-losers design	1
A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	1
Stochastic curtailment tests for phase II trial with time-to-event outcome using the concept of relative time in the case of non-proportional hazards	1
Guest Editors’ Note on the Special Issue Real-World Evidence	1
Reverse graphical approaches for multiple test procedures	1
Response adaptive randomization design for a two-stage study with binary response	1
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	1
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	1
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials	1
Do strict decision criteria hamper productivity in the pharmaceutical industry?	1
Adaptive Multiple Comparison Sequential Design (AMCSD) for clinical trials	1
Epistemic uncertainty in Bayesian predictive probabilities	1
Miettinen and Nurminen score statistics revisited	1
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials	1
A Bayesian model for combining standardized mean differences and odds ratios in the same meta-analysis	1
Borrowing historical information to improve phase I clinical trials using meta-analytic-predictive priors	1
Response to letter to editor	1
Two-stage designs with small sample sizes	1
A new type of generalized information criterion for regularization parameter selection in penalized regression with application to treatment process data	1
Networked knowledge, combinatorial creativity, and (statistical) innovation	1
Multi-arm multi-stage clinical trials for time-to-event outcomes	1
Sample size calculation using Markov chains for a one-arm study of heroin administration routes	1
A randomized Bayesian optimal phase II design with binary endpoint	1
RESTART trial design: two-stage seamless transition design with operational considerations	1
Robust estimates of regional treatment effects in multiregional randomized clinical trials with ordinal responses	1
Evaluation of the lifetime performance index on first failure progressive censored data based on Topp Leone Alpha power exponential model applied on HPLC data	1
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	1
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	1
Homogeneity test of several covariance matrices with high-dimensional data	1
Multi-stage dose expansion cohort (MSDEC) design with Bayesian stopping rule	1

Statistical learning in preclinical drug proarrhythmic assessment	1
On Reference-based Imputation for Analysis of Incomplete Repeated Binary Endpoints	1
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	1
An optimal response adaptive design for multi-treatment clinical trials with ordinal categorical outcomes	1
A win ratio-based framework to combine multiple clinical endpoints in exploratory basket trials	0
Applied Meta-Analysis with R and Stata, 2nd Edition	0
Drug response hysteresis in the concentration-QTc analysis of early clinical trials	0
A pragmatic approach for dynamically incorporating predicate device data in prospective diagnostic test studies	0
Comment on ‘statistical consideration and challenges in bridging study of personalized medicine’: a modified variance for sensitivity analysis	0
REFEREES FOR VOLUME 28	0
Four-parameter paired response curve for serial dilution assays	0
Optimal dose escalation methods using deep reinforcement learning in phase I oncology trials	0
Improved confidence estimation for the binomial proportion with applications to clinical studies	0
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	0
On approximate equality of Z-values of the statistical tests for win statistics (win ratio, win odds, and net benefit)	0
Up-front matching: an ongoing recruitment method for prospective observational studies that mimics randomization for selected baseline covariates	0
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	0
The impact of misclassification errors on the performance of biomarkers based on next-generation sequencing, a simulation study	0
Novel 3-arm wait-list controlled trial designs together with mixed-effects analysis improve precision of treatment effect estimators	0
Re: Transporting survival of an HIV clinical trial to the external target populations	0
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	0
Utility of real-world evidence in biosimilar development	0
Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials	0
Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves	0
Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design	0
Net benefit of diagnostic tests for multistate diseases: an indicator variables approach	0
A constrained optimum adaptive design for dose finding in early phase clinical trials	0
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	0
Small sample adjustment for inference without assuming orthogonality in a mixed model for repeated measures analysis	0
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	0
Assess predictive values of a binary diagnostic test under a nested case–control design	0
Sample size estimation for recurrent event data using multifrailty and multilevel survival models	0
The Ci3+3 design for dual-agent combination dose-finding clinical trials	0
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	0
Optimal two-phase sampling for comparing correlated areas under the ROC curves of two screening tests in the presence of verification bias	0
Handbook of meta-analysis	0
Risk difference, relative risk, and odds ratio for non-inferiority clinical trials with risk rate endpoint	0
Response to Comment on ‘Statistical Consideration and Challenges in Bridging Study of Personalized Medicine’: A modified variance for sensitivity	0
Bayesian approaches to benefit-risk assessment for diagnostic tests	0
Interval estimation of relative risks for combined unilateral and bilateral correlated data	0
Implementing the meta-analytic approach for the evaluation of surrogate endpoints in SAS and R: a word of caution	0
Bigger and bigger circles - the expanding biopharmaceutical statistician’s toolbox	0
Dose-finding based on feasibility and late-onset toxicity in adoptive cell therapy trials	0
Bayesian analyses of multiple random change points in survival models with applications to clinical trials	0
CORRECTION	0
Robust safety monitoring and signal detection using alternatives to the standard poisson distribution	0
Comments on ”Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	0
Saddlepoint p-values for a class of location-scale tests	0
Determining the late effect parameter in the Fleming-Harrington test using asymptotic relative efficiency in cancer immunotherapy clinical trials	0
Whole-cage randomization for animal studies with unequal cage or group sizes	0
Estimation of treatment effects in early-phase randomized clinical trials involving external control data	0
Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	0
Leveraging real-world data to conduct externally controlled trial for rare diseases with count-type endpoints: utilizing multiple entries – a simulation study	0
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	0
Empower clinical development by harnessing data from diverse sources: methodology, applications and regulatory perspectives	0
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	0
Leveraging pharmacokinetic parameters as covariate in Bayesian logistic regression model to optimize dose selection in early phase oncology trial	0
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	0
Random intercept hierarchical linear model for multi-regional clinical trials	0
Innovative methods for rare disease drug development	0
A composite semiparametric homogeneity test for the distributions of multigroup interval-bounded longitudinal data	0
Group sequential designs for cancer immunotherapy trial with delayed treatment effect	0
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	0
REFEREES FOR VOLUME 31	0
Biomarker-driven basket trial designs: origins and new methodological developments	0
Simulating survival data when one subgroup lacks information	0
A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research	0
A Bayesian three-tier quantitative decision-making framework for single arm studies in early phase oncology	0
A confirmatory basket design considering non-inferiority and superiority testing	0
Adaptive sequential design for phase II single-arm oncology trials: an expansion of Simon’s design	0
A promising subgroup identification method based on a genetic algorithm for censored survival data	0
Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life	0
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	0
Step-down multiple testing procedures for the overall population and partitioning subgroups	0
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	0
Confidence intervals for the common odds ratio based on the inverse sinh transformation	0
A stochastically curtailed single‐arm phase II trial design for binary outcomes	0
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	0
Statistical methods to control for confounders in rare disease settings that use external control	0
A comparison of Bayesian and score methods for interval estimates of positive/negative likelihood ratios in support of diagnostic device performance evaluation	0
Diagnostic evaluation of pharmacokinetic features of functional markers	0
Response to comment on “Transporting survival of an HIV clinical trial to the external target populations by Lee et al. (2024)”	0
Establishment of RWS guidance reflecting contributions of China to regulatory science	0
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	0
Referees for Volume 33	0
Covariate adjusted meta-analytic predictive (CA-MAP) prior for historical borrowing using patient-level data	0
Quantile regression shrinkage and selection via the Lqsso	0
Association of the medication protocols and longitudinal change of COVID-19 symptoms: a hospital-based mixed-statistical methods study	0
Incorporating external real-world data (RWD) in confirmatory adaptive design	0
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	0
Improved automated spot counting and modeling with bias correction	0
Assessment of nonlinear dose–response relationships via nonparametric regression	0
Retraction: A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	0
Design and analysis of drop-the-losers studies using binary endpoints in the rare disease setting	0
A shrinkage estimator for subgroup analysis without the exchangeability assumption	0