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 2021-02-01 to 2025-02-01.)

Article	Citations
Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life	14
Implementing the meta-analytic approach for the evaluation of surrogate endpoints in SAS and R: a word of caution	13
Comment on ‘statistical consideration and challenges in bridging study of personalized medicine’: a modified variance for sensitivity analysis	11
Heterogeneous logistic regression for estimation of subgroup effects on hypertension	10
Borrowing historical information to improve phase I clinical trials using meta-analytic-predictive priors	10
Risk difference, relative risk, and odds ratio for non-inferiority clinical trials with risk rate endpoint	9
A Bayesian three-tier quantitative decision-making framework for single arm studies in early phase oncology	9
Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials	9
Multi-stage dose expansion cohort (MSDEC) design with Bayesian stopping rule	9
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	8
A win ratio-based framework to combine multiple clinical endpoints in exploratory basket trials	7
Optimised point estimators for multi-stage single-arm phase II oncology trials	7
Assess predictive values of a binary diagnostic test under a nested case–control design	6
Comparison of profile-likelihood-based confidence intervals with other rank-based methods for the two-sample problem in ordered categorical data	6
Group sequential designs for cancer immunotherapy trial with delayed treatment effect	6
Biomarker-driven basket trial designs: origins and new methodological developments	6
Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives	6
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	6
Weighted log-rank tests for censored data under Wei’s urn design: saddlepoint approximation and confidence intervals	5
Leveraging pharmacokinetic parameters as covariate in Bayesian logistic regression model to optimize dose selection in early phase oncology trial	5
Forecasting determinants of recurrence in lung cancer patients exploiting various machine learning models	5
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment	5
Net benefit of diagnostic tests for multistate diseases: an indicator variables approach	5
Association of the medication protocols and longitudinal change of COVID-19 symptoms: a hospital-based mixed-statistical methods study	5
Re: Transporting survival of an HIV clinical trial to the external target populations	5

Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	5
A comparison of Bayesian and score methods for interval estimates of positive/negative likelihood ratios in support of diagnostic device performance evaluation	5
Small sample adjustment for inference without assuming orthogonality in a mixed model for repeated measures analysis	5
Innovative methods for rare disease drug development	5
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	5
Determining the late effect parameter in the Fleming-Harrington test using asymptotic relative efficiency in cancer immunotherapy clinical trials	5
Applying machine learning-based multiple imputation methods to nonparametric multiple comparisons in longitudinal clinical studies	4
Robust safety monitoring and signal detection using alternatives to the standard poisson distribution	4
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	4
A novel approach to augment single-arm clinical studies with real-world data	4
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	4
Bayesian Hierarchy model for population pharmacokinetics of amikacin in Japanese clinical population	4
A stochastically curtailed single‐arm phase II trial design for binary outcomes	4
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics	4
Different view of the diagnostics test accuracy measures and optimal cut-off point selection procedure under tree or umbrella ordering	4
A nonparametric approach to confidence intervals for concordance index and difference between correlated indices	4
The 2009 FDA PRO guidance, Potential Type I error, Descriptive Statistics and Pragmatic estimation of the number of interviews for item elicitation	3
Correction	3
Bayesian approaches to benefit-risk assessment for diagnostic tests	3
Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design	3
Quantile regression shrinkage and selection via the Lqsso	3
Statistical operating characteristics of current early phase dose finding designs with toxicity and efficacy in oncology	3
Drug response hysteresis in the concentration-QTc analysis of early clinical trials	3
Dose-finding based on feasibility and late-onset toxicity in adoptive cell therapy trials	3
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	3
Estimands and estimators of two-level methods using return to baseline strategy for longitudinal clinical trials with incomplete daily patient reported outcomes	3
Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study	3
Emerging insights and commentaries – MMRM vs LOCF	3
Adaptive sequential design for phase II single-arm oncology trials: an expansion of Simon’s design	3
Real world data (RWD) in pediatrics	3
Do strict decision criteria hamper productivity in the pharmaceutical industry?	3
A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research	3
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial	3
Retraction: A Bayesian joint model for multivariate longitudinal and time-to-event data with application to ALL maintenance studies	3
Step-down multiple testing procedures for the overall population and partitioning subgroups	3
Estimating treatment effect in randomized trial after control to treatment crossover using external controls	3
Dynamic borrowing from a single prior data source using the conditional power prior	3
How to select the initial dose for a pediatric study?	3
Novel 3-arm wait-list controlled trial designs together with mixed-effects analysis improve precision of treatment effect estimators	3
Referees for Volume 33	3
Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices	3
Guest editors’ note on the special issue International Chinese Statistical Association (ICSA) Applied Statistics Symposium 2021	3
Handbook of meta-analysis	3
Four-parameter paired response curve for serial dilution assays	3
Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	3
Epistemic uncertainty in Bayesian predictive probabilities	3
Assessment of nonlinear dose–response relationships via nonparametric regression	2
Reflections on estimands for patient-reported outcomes in cancer clinical trials	2
Latent class analysis of post-acute sequelae of SARS-CoV-2 infection	2
scRAA: the development of a robust and automatic annotation procedure for single-cell RNA sequencing data	2

Estimand in benefit-risk assessment	2
Evaluation of the lifetime performance index on first failure progressive censored data based on Topp Leone Alpha power exponential model applied on HPLC data	2
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer	2
Dynamic incorporation of real world evidence within the framework of adaptive design	2
Randomization tests in clinical trials with multiple imputation for handling missing data	2
Statistical methods to control for confounders in rare disease settings that use external control	2
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	2
REFEREES FOR VOLUME 31	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
Saddlepoint p-values for a class of location-scale tests	2
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes	2
Group sequential multi-arm multi-stage survival trial design with treatment selection	2
A Cholesky-based sparse covariance estimation with an application to genes data	2
Up-front matching: an ongoing recruitment method for prospective observational studies that mimics randomization for selected baseline covariates	2
Equivalence tests under the Cox-Aalen model and the partly Aalen model	2
The Ci3+3 design for dual-agent combination dose-finding clinical trials	2
Random intercept hierarchical linear model for multi-regional clinical trials	2
Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials	2
A shrinkage estimator for subgroup analysis without the exchangeability assumption	2
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data	2
A Bayesian joint bent-cable model for longitudinal measurements and survival time with heterogeneous random-effects distributions	2
Diagnostic evaluation of pharmacokinetic features of functional markers	2
Confidence intervals for the common odds ratio based on the inverse sinh transformation	2
Adaptive two-stage seamless sequential design for clinical trials	2
Testing the homogeneity of proportions for combined unilateral and bilateral data	2
A win ratio approach for comparing crossing survival curves in clinical trials	2
Whole-cage randomization for animal studies with unequal cage or group sizes	2