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 2021-08-01 to 2025-08-01.)

Article	Citations
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	24
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	21
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	21
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	17
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	13
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	13
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	12
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	11
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials	11
A stochastically curtailed single‐arm phase II trial design for binary outcomes	10
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	10
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	10
Optimised point estimators for multi-stage single-arm phase II oncology trials	10
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	10
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	9
Estimand in benefit-risk assessment	9
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	9
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	8
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	8
Statistical innovation for next generation pharmaceutical development	7
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	7
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	7
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	7
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	7
A shrinkage estimator for subgroup analysis without the exchangeability assumption	7

An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	7
Evaluating bias control strategies in observational studies using frequentist model averaging	7
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	7
Whole-cage randomization for animal studies with unequal cage or group sizes	7
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	6
Strategies for successful dose optimization in oncology drug development: a practical guide	6
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	6
Machine learning approach for detection of MACE events within clinical trial data	6
Optimal designs for phase II clinical trials with heterogeneous patient populations	6
Calibrated dynamic borrowing using capping priors	6
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	6
Comparison of continuous, binary, and ordinal endpoints	5
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	5
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	5
Defining optimal cut-off points for multiple class ROC analysis: generalization of the Index of Union method	5
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	5
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	5
Adjusted win ratio using the inverse probability of treatment weighting	5
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	5
Bayesian censored piecewise regression mixture models with skewness	4
Bayesian method for comparing F1 scores in the absence of a gold standard	4
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	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
Sequential monitoring of cancer immunotherapy trial with random delayed treatment effect	4
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	4
Sample size determination for a study with variable follow-up time	4
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	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
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	4
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	4
FDA experiences with a centralized statistical monitoring tool	4
Double machine learning methods for estimating average treatment effects: a comparative study	4
Bayesian screening for feature selection	4
Guest editors’ note on special issue on application of estimand	4
Combination MCP-Mod for two-drug combination dose-ranging studies	4
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data	4
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	4
The use of real-world data for clinical investigation of effectiveness in drug development	4
Analysis of continuous monitoring device data	4
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	4
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	4
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	3
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	3
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	3
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	3
Random intercept hierarchical linear model for multi-regional clinical trials	3
Establishment of RWS guidance reflecting contributions of China to regulatory science	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Real world data (RWD) in pediatrics	3

Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study	3
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	3
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	3
Isotonic design for phase I cancer clinical trials with late-onset toxicities	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	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
Assessment of nonlinear dose–response relationships via nonparametric regression	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Emerging insights and commentaries – MMRM vs LOCF	3
Innovative methods for rare disease drug development	3
Conditional power in vaccine trials with seasonal variations	3
Conditional borrowing external data to establish a hybrid control arm in randomized 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
On F _β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3