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 2021-06-01 to 2025-06-01.)

Article	Citations
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	20
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	19
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	19
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	17
Quasi-Empirical Bayes methods for parameter estimation involving many small samples	13
A practical analysis procedure on generalizing comparative effectiveness in the randomized clinical trial to the real-world trial-eligible population	12
Introduction to the special issue Advances in statistical methods for the assessment of patient-centered outcomes	12
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials	10
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	9
A stochastically curtailed single‐arm phase II trial design for binary outcomes	9
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	9
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	9
Optimised point estimators for multi-stage single-arm phase II oncology trials	9
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	8
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	8
Estimand in benefit-risk assessment	8
Testing the homogeneity of proportions for combined unilateral and bilateral data	7
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	7
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data	7
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	7
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	7
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	7
Statistical innovation for next generation pharmaceutical development	7
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	7
A shrinkage estimator for subgroup analysis without the exchangeability assumption	7

Whole-cage randomization for animal studies with unequal cage or group sizes	7
Non-constant mean relative potency for antibody-dependent cellular cytotoxicity assays	7
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift	6
Optimization of EWOC principle in BLRM design for phase 1 oncology trials	6
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift	6
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	6
Evaluating bias control strategies in observational studies using frequentist model averaging	6
Optimal designs for phase II clinical trials with heterogeneous patient populations	6
Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects	6
Calibrated dynamic borrowing using capping priors	5
MOVER tests for non-inferiority of the difference between two binary-outcome treatments in the matched-pairs design	5
Comparison of continuous, binary, and ordinal endpoints	5
Directed Acyclic Graph Assisted Method For Estimating Average Treatment Effect	5
Machine learning approach for detection of MACE events within clinical trial data	5
Adjusted win ratio using the inverse probability of treatment weighting	5
Strategies for successful dose optimization in oncology drug development: a practical guide	5
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	5
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	5
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	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
Isotonic design for phase I cancer clinical trials with late-onset toxicities	4
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling	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
Bayesian censored piecewise regression mixture models with skewness	4
Estimation of median survival time and its 95% confidence interval using SAS PROC LIFETEST	4
Guest editors’ note on special issue on application of estimand	4
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	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
Clustering plasma concentration-time curves: applications ofunsupervised learning in pharmacogenomics	4
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data	4
Assessing the incidence and severity of drug adverse events: a Bayesian hierarchical cumulative logit model	4
Reflections on estimands for patient-reported outcomes in cancer clinical trials	3
Random intercept hierarchical linear model for multi-regional clinical trials	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	3
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	3
Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	3
The use of real-world data for clinical investigation of effectiveness in drug development	3
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Real world data (RWD) in pediatrics	3
Dynamic borrowing from a single prior data source using the conditional power prior	3
On F _β -score for medical diagnostics tests of binary diseases: proposing new measures of accuracy	3

Assessment of nonlinear dose–response relationships via nonparametric regression	3
Conditional power in vaccine trials with seasonal variations	3
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	3
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study	3
Innovative methods for rare disease drug development	3
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Group sequential multi-arm multi-stage survival trial design with treatment selection	3
Adaptive two-stage seamless sequential design for clinical trials	3
Emerging insights and commentaries – MMRM vs LOCF	3
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	3
Bayesian method for comparing F1 scores in the absence of a gold standard	3
Combination MCP-Mod for two-drug combination dose-ranging studies	3
Using Bayesian hierarchical models for controlled post hoc subgroup analysis of clinical trials: application to smoking cessation treatment in American Indians and Alaska Natives	3
Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson’s disease	3
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	3
A semi-parametric approach for time-dependent ROC curves with nonignorable missing biomarker	2
Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	2
An improved biomarker-guided adaptive patient enrichment design for oncology trials	2
Use of alternative and confirmatory data in support of rare disease drug development	2
Addressing sequential and concurrent treatment regimens in a small n sequential, multiple assignment, randomized trial (snSMART) in the MISTIC study	2
Flexible parametric accelerated failure time model	2
Correction	2
Assessing model accuracy using random data split: a simulation study	2
Estimation of treatment effects in early-phase randomized clinical trials involving external control data	2
Establishment of RWS guidance reflecting contributions of China to regulatory science	2
Dynamic incorporation of real world evidence within the framework of adaptive design	2
Homogeneity test of several covariance matrices with high-dimensional data	2
Developing large language models to detect adverse drug events in posts on x	2
Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials	2
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	2
A new basket trial design based on clustering of homogeneous subpopulations	2
Meta-analysis application to hERG safety evaluation in clinical trials	2
Identifying the clinical relative importance of each correlated outcome variables in multivariate approach: an exploration using ACCORD trial data	2
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics	2
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	2
Optimum designs for clinical trials in personalized medicine when response variance depends on treatment	2
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups	2
Bayesian design of clinical trials using the scale transformed power prior	2
The value of a two-armed Bayesian response adaptive randomization trial	2
Response to Comment on “Emerging insights and commentaries – MMRM vs LOCF by Naitee Ting”	2
Novel machine learning approach to differential cell flow cytometry analysis based on projection pursuit	2
Bayesian analyses of multiple random change points in survival models with applications to clinical trials	2