OOIR: Observatory of International Research

Papers

(The TQCC of Journal of Biopharmaceutical Statistics is 3. 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 2021-12-01 to 2025-12-01.)

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	24
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	15
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	15
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	14
A stochastically curtailed single‐arm phase II trial design for binary outcomes	13
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	13
Optimised point estimators for multi-stage single-arm phase II oncology trials	12
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	11
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	11
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	11
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	11
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	11
Whole-cage randomization for animal studies with unequal cage or group sizes	10
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	10
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	9
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	9
Estimand in benefit-risk assessment	8
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	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
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	8
Machine learning approach for detection of MACE events within clinical trial 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
Strategies for successful dose optimization in oncology drug development: a practical guide	7
Statistical innovation for next generation pharmaceutical development	7
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	7
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	7
Enhancing dose selection in phase I cancer trials: Extending the Bayesian Logistic Regression Model with non-DLT adverse events integration	7
Evaluating bias in the anchor method for the minimal clinically important difference: a simulation approach	7
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	6
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	6
Comparison of continuous, binary, and ordinal endpoints	6
Optimal designs for phase II clinical trials with heterogeneous patient populations	6
Defining optimal cut-off points for multiple class ROC analysis: generalization of the Index of Union method	6
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	6
Adjusted win ratio using the inverse probability of treatment weighting	6
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	6
Analysis of continuous monitoring device data	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	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
Sequential monitoring of cancer immunotherapy trial with random delayed treatment effect	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	5
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	5
Linear regression models for analyzing the covariate-adjusted Youden index and associated cut-off points in three diagnostic groups	5
Bayesian screening for feature selection	5
FDA experiences with a centralized statistical monitoring tool	5
Bayesian censored piecewise regression mixture models with skewness	5
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	4
Recovery of overall survival information from treatment switching in oncology trials using multiple imputation	4
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	4
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	4
Isotonic design for phase I cancer clinical trials with late-onset toxicities	4
Combination MCP-Mod for two-drug combination dose-ranging studies	4
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	4
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	4
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	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
Bayesian method for comparing F1 scores in the absence of a gold standard	4
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study	4
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	4
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome 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
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
BOP2-FE: Bayesian optimal phase II design with futility and efficacy-stopping boundaries	4
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	4
Conditional power in vaccine trials with seasonal variations	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
Sample size determination for a study with variable follow-up time	4

Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	3
Estimation of treatment effects in early-phase randomized clinical trials involving external control data	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Random intercept hierarchical linear model for multi-regional clinical trials	3
Assessment of nonlinear dose–response relationships via nonparametric regression	3
On F _β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3
Establishment of RWS guidance reflecting contributions of China to regulatory science	3
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	3
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	3
Emerging insights and commentaries – MMRM vs LOCF	3
Dynamic incorporation of real world evidence within the framework of adaptive design	3
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Real world data (RWD) in pediatrics	3
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	3
Adaptive two-stage seamless sequential design for clinical trials	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3