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 2020-11-01 to 2024-11-01.)

Article	Citations
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials	14
Incorporating propensity scores for evidence synthesis under bayesian framework: review and recommendations for clinical studies	13
Propensity score-integrated Bayesian prior approaches for augmented control designs: a simulation study	10
Log-rank tests for censored clustered data under generalized randomized block design: Saddlepoint approximation	10
Evaluating bias control strategies in observational studies using frequentist model averaging	10
Leverage multiple real-world data sources in single-arm medical device clinical studies	9
Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials	9
Using supervised machine learning approach to predict treatment outcomes of vedolizumab in ulcerative colitis patients	9
Weighted log-rank tests for left-truncated data under Wei’s urn design: saddlepoint p-values and confidence intervals	9
Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources	9
Dose-finding design and benchmark for a right censored endpoint	8
A novel approach to augment single-arm clinical studies with real-world data	8
Matching design for augmenting the control arm of a randomized controlled trial using real-world data	7
Dynamic borrowing from a single prior data source using the conditional power prior	7
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials	6
Restricted mean survival time and confidence intervals by empirical likelihood ratio	6
Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer	6
Joint comparison of the predictive values of multiple binary diagnostic tests: an extension of McNemar’s test	6
A new basket trial design based on clustering of homogeneous subpopulations	6
Flexible parametric accelerated failure time model	6
Evidence synthesis analysis with prioritized benefit outcomes in oncology clinical trials	6
Bayesian joint modeling for partially linear mixed-effects quantile regression of longitudinal and time-to-event data with limit of detection, covariate measurement errors and skewness	5
Bayesian sample size determination in a three-arm non-inferiority trial with binary endpoints	5
Perspectives on informative Bayesian methods in pediatrics	5
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing	5

P-values and confidence intervals of linear rank tests for left-truncated data under truncated binomial design	5
A year in review: artificial intelligence permeates into mainstream statistics in pharmaceutical product development at a laggard pace	5
Randomized two-stage optimal design for interval-censored data	5
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies	5
Evidence inconsistency degrees of freedom in Bayesian network meta-analysis	5
The win odds: statistical inference and regression	5
Bayesian Additive Regression Trees (BART) with covariate adjusted borrowing in subgroup analyses	5
Parameter estimation of Weibull distribution for the number of days between drug administration and early onset adverse event	5
Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study	5
Application of estimand framework in ICH E9 (R1) to safety evaluation	4
Defective 3-parameter Gompertz model with frailty term for estimating cure fraction in survival data	4
Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment	4
Forecasting determinants of recurrence in lung cancer patients exploiting various machine learning models	4
Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods	4
Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials	4
Practical guidance on modeling choices for the virtual twins method	4
A nonparametric approach to confidence intervals for concordance index and difference between correlated indices	4
A collection of parametric modal regression models for bounded data	4
Matching within a hybrid RCT/RWD: framework on associated causal estimands	4
Application of estimand framework in ICH E9 (R1) to vaccine trials	4
The Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials	4
Adjusted win ratio using the inverse probability of treatment weighting	3
Transporting survival of an HIV clinical trial to the external target populations	3
Dynamic incorporation of real world evidence within the framework of adaptive design	3
Estimand in benefit-risk assessment	3
Inferential properties with a novel two parameter Poisson generalized Lindley distribution with regression and application to INAR(1) process	3
Design of paediatric trials with benefit-risk endpoints using a composite score of adverse events of interest (AEI) and win-statistics	3
Weighted log-rank tests for censored data under Wei’s urn design: saddlepoint approximation and confidence intervals	3
Modelling non-linear patterns of time-varying intervention effects on recurrent events in infectious disease prevention studies	3
Challenges and potential strategies utilizing external data for efficacy evaluation in small-sized clinical trials	3
Integrating real world data and clinical trial results using survival data reconstruction and marginal moment-balancing weights	3
Optimal designs for phase II clinical trials with heterogeneous patient populations	3
Assessing model accuracy using random data split: a simulation study	3
Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges	3
Testing the homogeneity of proportions for combined unilateral and bilateral data	3
Real world data (RWD) in pediatrics	3
Confidence intervals of mean residual life function in length-biased sampling based on modified empirical likelihood	3
Recommended confidence intervals for the conditional odds ratio in matched-pairs designs	3
Isotonic design for phase I cancer clinical trials with late-onset toxicities	3
Deep historical borrowing framework to prospectively and simultaneously synthesize control information in confirmatory clinical trials with multiple endpoints	3
Flexible seamless 2-in-1 design with sample size adaptation	3
Survival stacking with multiple data types using pseudo-observation-based-AUC loss	3
Calibrated dynamic borrowing using capping priors	3
Optimal biological dose selection in dose-finding trials with model-assisted designs based on efficacy and toxicity: a simulation study	3
A win ratio approach for comparing crossing survival curves in clinical trials	3
Equivalence tests under the Cox-Aalen model and the partly Aalen model	3
Using surrogate information to improve confirmatory platform trial with sample size re-estimation	3
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US	3
In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f ₂	3
On dependence assumption in p-value based multiple test procedures	3

Retrieved-Dropout-Based multiple imputation for time-to-event data in cardiovascular outcome trials	3
Generalized exponentiated unit Gompertz distribution for modeling arthritic pain relief times data: classical approach to statistical inference	3
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment	3
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials	2
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints	2
Case study using RWD in the context of a pivotal trial for regulatory approval in a rare disease	2
[Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework	2
Group sequential multi-arm multi-stage survival trial design with treatment selection	2
Statistics and machine learning methods for EHR data – from data extraction to data analytics	2
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data	2
Mixed-effects models for censored data with autoregressive errors	2
Estimands and estimators of two-level methods using return to baseline strategy for longitudinal clinical trials with incomplete daily patient reported outcomes	2
Comparison of statistical methodologies used to estimate the treatment effect on time-to-event outcomes in observational studies	2
Saddlepoint approximation for weighted log-rank tests based on block truncated binomial design	2
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population	2
Fast tipping point sensitivity analyses in clinical trials with missing continuous outcomes under multiple imputation	2
Investigation of the relationship between heart rate and functional class in pulmonary hypertension	2
Inclusion of unexposed subjects improves the precision and power of self-controlled case series method	2
Two-stage response adaptive randomization designs for multi-arm trials with binary outcome	2
Reflections on estimands for patient-reported outcomes in cancer clinical trials	2
Nonparametric inference of the area under ROC curve under two-phase cluster sampling	2
Randomization tests in clinical trials with multiple imputation for handling missing data	2
How to select the initial dose for a pediatric study?	2
Non-inferiority testing for qualitative microbiological methods:Assessing and improving the approach in USP <1223>	2
Addressing statistical issues when leveraging external control data in pediatric clinical trials using Bayesian dynamic borrowing	2
Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards	2
Clinical trial considerations for pediatric cancer drug development	2
Propensity score stratified MAP prior and posterior inference for incorporating information across multiple potentially heterogeneous data sources	2
Advancing drug development in pediatric oncology, a focus on cancer biology and targeted therapies: iMATRIX platform	2
Adaptive platform trials: the impact of common controls on type one error and power	2
Beyond p < .05: a critical review of new Bayesian proposals for assessing the p-value	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
A two-stage approach for joint modeling of longitudinal measurements and competing risks data	2
A Cholesky-based sparse covariance estimation with an application to genes data	2
Rectangular multivariate normal prediction regions for setting reference regions in laboratory medicine	2
Assessing adverse events in clinical trials during the era of the COVID-19 pandemic	2
Reweighting estimators to extend the external validity of clinical trials: methodological considerations	2
The value of a two-armed Bayesian response adaptive randomization trial	2