OOIR: Observatory of International Research

Papers

(The TQCC of Journal of Biopharmaceutical Statistics is 2. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2022-05-01 to 2026-05-01.)

Article	Citations
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	27
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	21
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	18
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	17
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	14
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	12
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	12
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	11
Whole-cage randomization for animal studies with unequal cage or group sizes	10
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	10
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	10
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	10
A simulation study comparing backfill and randomized expansion in oncology dose optimization	9
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	9
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	9
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	8
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	8
Statistical innovation for next generation pharmaceutical development	8
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	8
A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	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
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	7
Defining optimal cut-off points for multiple class ROC analysis: generalization of the Index of Union method	7

Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	7
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	7
Enhancing dose selection in phase I cancer trials: Extending the Bayesian Logistic Regression Model with non-DLT adverse events integration	7
Strategies for successful dose optimization in oncology drug development: a practical guide	7
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	7
Machine learning approach for detection of MACE events within clinical trial data	7
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	7
Adjusted win ratio using the inverse probability of treatment weighting	7
Comparison of continuous, binary, and ordinal endpoints	6
Optimal designs for phase II clinical trials with heterogeneous patient populations	6
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	6
Sequential monitoring of cancer immunotherapy trial with random delayed treatment effect	6
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	6
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	5
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	5
Analysis of continuous monitoring device data	5
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	5
Bayesian screening for feature selection	5
Guest editors’ note on special issue on application of estimand	5
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	5
Special issue on dose optimization	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	5
Linear regression models for analyzing the covariate-adjusted Youden index and associated cut-off points in three diagnostic groups	5
Sample size determination for a study with variable follow-up time	5
Bayesian analysis of the causal reference-based model for missing data in clinical trials	5
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	5
FDA experiences with a centralized statistical monitoring tool	5
Combination MCP-Mod for two-drug combination dose-ranging studies	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
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	4
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	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
Conditional power in vaccine trials with seasonal variations	4
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	4
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	4
Isotonic design for phase I cancer clinical trials with late-onset toxicities	4
The use of real-world data for clinical investigation of effectiveness in drug development	4
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
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	4
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	4
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data	4
Real world data (RWD) in pediatrics	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3
Emerging insights and commentaries – MMRM vs LOCF	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
Enhanced doubly robust estimation in clinical trials accounting for intercurrent events	3

Change-point detection in Weibull-accelerated failure time models via narrowest significance pursuit	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3
On F _β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3
Random intercept hierarchical linear model for multi-regional clinical trials	3
Assessment of nonlinear dose–response relationships via nonparametric regression	3
Evaluating bias reduction methods in binary Emax model for reliable dose-response estimation	3
A win ratio approach for comparing crossing survival curves in clinical trials	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
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	3
Establishment of RWS guidance reflecting contributions of China to regulatory science	3
Applications of correlative analysis for chemistry, manufacturing and controls in cell and gene therapy	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	3
Common risk difference and corresponding confidence interval adjusted for multiple factors – comparison of seven different methods	3
BOP2-FE: Bayesian optimal phase II design with futility and efficacy-stopping boundaries	3
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	2
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	2
Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials	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
Statistical considerations for using tolerance interval to set product specification for normally distributed attribute	2
Assessing model accuracy using random data split: a simulation study	2
Random effect restricted mean survival time model	2
Informative event rate in study determination, study design, and interim analysis monitoring with non-proportional hazards	2
Bayesian analyses of multiple random change points in survival models with applications to clinical trials	2
Identifying the clinical relative importance of each correlated outcome variables in multivariate approach: an exploration using ACCORD trial data	2
Comparing diagnostic tests and biomarkers based on benefit-risk under tree orderings of disease classes	2
Correction	2
Group sequential designs for cancer immunotherapy trial with delayed treatment effect	2
An enhanced exact permutation rank-based inferential seamless phase 2/3 design	2
Meta-analysis application to hERG safety evaluation in clinical trials	2
Inverse probability weighted Bayesian dynamic borrowing for estimation of marginal treatment effects with application to hybrid control arm oncology studies	2
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	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
An improved biomarker-guided adaptive patient enrichment design for oncology trials	2
Generalized triple outcome decision-making in basket trials	2
Novel machine learning approach to differential cell flow cytometry analysis based on projection pursuit	2
Reimagining optimization of clinical trials efficiency through use of statistical innovation, technology and non-standard data sources	2
Response to Comment on “Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	2
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	2
Estimation of the selected treatment mean in two stage drop-the-losers design	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	2
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	2
The role of regulatory flexibility in the review and approval process of rare disease drug development	2
The value of a two-armed Bayesian response adaptive randomization trial	2
Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>	2
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups	2
Investigating the impact of data monitoring committee recommendations on the probability of trial success	2
Use of alternative and confirmatory data in support of rare disease drug development	2
Bayesian design of clinical trials using the scale transformed power prior	2
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	2
Mind the gap: Bayesian equipoise calibration of clinical trial designs	2
Estimation of treatment effects in early-phase randomized clinical trials involving external control data	2
Estimation of treatment effects in early phase randomized clinical trials involving multiple data sources for external control	2
Developing large language models to detect adverse drug events in posts on x	2