OOIR: Observatory of International Research

Papers

(The median citation count of Statistics in Biopharmaceutical Research is 1. 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
Rejoinder to Commentaries on “Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event”	34
A Closer Look at the Kernels Generated by the Decision and Regression Tree Ensembles	31
Good Data Science Practice: Moving toward a Code of Practice for Drug Development (Rejoinder)	25
Editor’s Note: Special Section on a Collection of Articles on Opportunities and Challenges in Utilizing Real-World Data for Clinical Trials and Medical Product Development	21
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types	16
Combined Tests Based on Restricted Mean Time Lost for Competing Risks Data	15
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion	14
Eliciting the Discount Parameter in a Power Prior Method on the Basis of the Type I Error Consideration	14
Similarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond	14
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	13
Composite Endpoints in Cardio-Renal Clinical Outcome Trials	12
On Variance Estimation for the One-Sample Log-Rank Test	11
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments	11
A Test for Treatment Effects Based on the Exact Distribution of an Ordinary Least-Square Estimator in Sequential Parallel Comparison Design	10
Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators	10
Leveraging Real-World Data in COVID-19 Response	9
Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation	8
Comment on “Randomization Tests to Address Disruptions in Clinical Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions”	8
Three-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement	7
A Modification of Location Commensurate Power Prior in Clinical Trials	7
Rejoinder: Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	7
Selected Articles from the Nonclinical Biostatistics Conference 2021	7
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	7
Editor’s Note: Special Section on Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes	7
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial	6

The Use of Machine Learning in Regulatory Drug Safety Evaluation	6
The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis	6
A Composite Endpoint for Treatment Benefit According to Patient Preference	6
The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis	6
Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring	6
A Unified Three-State Model Framework for Analysis of Treatment Crossover in Survival Trials	6
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	5
A Method for Ensuring a Consistent Dose–Response Relationship Between An Entire Population and One Region in Multiregional Dose–Response Studies Using MCP-Mod	5
Comment on “Estimands and Their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions”	5
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing	5
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics	5
Implementation of Statistical Innovation in a Pharmaceutical Company	5
Dose Optimization for Novel Oncology Agents: Design Options and Strategies	5
Correction	5
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow	5
Rejoinder to Letter to the Editor—Selecting an Optimal Design for a Nonrandomized Comparative Study: A Commentary on “Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Stu	4
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	4
Teasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments	4
A Basket Trial Design Based on Power Priors	4
Editor’s Note	4
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility	4
Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group	4
Editor’s Note	4
The 2019 Nonclinical Biostatistics Conference	4
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials	4
Comment on” Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions”	4
Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”: Is Real-World Evidence Real?	4
Special Issue for Selected Articles From the ISBS2019: Statistical Innovation and Contribution in the Era of Precision Healthcare	3
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	3
The Targeted Virtual Control Approach for Single-Arm Clinical Trials with External Controls	3
Possible Data-Generating Models of Longitudinal Continuous Outcomes and Intercurrent Events to Investigate Estimands	3
Enhancement of Basket Trial Designs with Incorporation of a Bayesian Three-Outcome Decision-Making Framework	3
Quantifying Replicability and Consistency in Systematic Reviews	3
A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic	3
Statistical Inference of the Probability of Passing the USP Dissolution Test	3
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types	3
Two-Stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers	3
Examples of Applying RWE Causal-Inference Roadmap to Clinical Studies	3
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints	3
Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes	3
Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints	3
Post-Test Diagnostic Accuracy Measures of a Continuous Test With a Disease of Ordinal Multistages	3
Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence	3
Probability of Study Success (PrSS) Evaluation Based on Multiple Endpoints in Late Phase Oncology Drug Development	3
Validity of Tests for Time-to-Event Endpoints in Studies with the Pocock and Simon Covariate-Adaptive Randomization	2
A Note on Stratification Errors in the Analysis of Clinical Trials	2
Deep Learning Based Multimodal Progression Modeling for Alzheimer’s Disease	2
Bayesian Optimal Phase II Design for Randomized Clinical Trials	2
Quick Multiple Test Procedures and p-Value Adjustments	2
Distribution of a P-Value When the Alternative Hypothesis is True for Binary Outcomes	2

Closed-Form Approximation of Correlation Matrix Among Fleming Harrington Test Statistics in MaxCombo Test: Comments on “Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A St	2
Efficient Estimation of the Efficacy and Safety Endpoints for Clinical Trials with Preplanned Dose Titrations	2
Adjusting for Time-Varying Treatment Switches in Randomized Clinical Trials: The Danger of Extrapolation and How to Address It	2
Comparing Dose Levels to Placebo using a Continuous Outcome in a Small n, Sequential, Multiple Assignment, Randomized trial (snSMART)	2
Establishing and Using Threshold of Surrogate Endpoint in Relation to Clinical Endpoint	2
Bayesian shrinkage estimation of credible subgroups for count data with excess zeros	2
We Need Subject Matter Expertise to Choose and Identify Causal Estimands: Comment on “Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event”	2
Direct Estimation for Commonly Used Pattern-Mixture Models in Clinical Trials	2
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	2
Combining Recurrent and Terminal Events Into a Composite Endpoint May Be Problematic	2
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	2
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction	2
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	2
Comparison of Adverse Event Risks in Randomized Controlled Trials with Varying Follow-Up Times and Competing Events: Results from an Empirical Study	2
Some Biostatistical Considerations About Real-World Data and Evidence in Clinical Studies, Especially for Regulatory Purposes	2
Developing a Targeted Learning-Based Statistical Analysis Plan	2
Minimizing Selection Bias Under the Blackwell and Hodges Model with an Equal Allocation Procedure in a Symmetric Allocation Space	2
Comparison of Sample Size Requirements of Randomized and Historically Controlled Trials Based on Calibrated Error Rates	2
Rejoinder to the Commentaries on “The Current Landscape in Biostatistics of Real-World Data and Evidence: Label Expansion”	2
Bayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes	1
A Flexible Analytical Framework for Reference-Based Imputation, Delta Adjustment and Tipping-Point Stress-Testing	1
An Alternative to Traditional Sample Size Determination for Small Patient Populations	1
Unsupervised Imputation of Non-Ignorably Missing Data Using Importance-Weighted Autoencoders	1
Combining Real-World and Randomized Control Trial Data Using Data-Adaptive Weighting via the On-Trial Score	1
Rejoinder	1
Dynamic Monitoring of Ongoing Clinical Trials	1
Bayesian Design of Superiority Trials: Methods and Applications	1
Bayesian Borrowing Methods for Count Data: Analysis of Incontinence Episodes in Patients with Overactive Bladder	1
Optimal Spiking Experiment for Noninferiority of Qualitative Microbiological Methods on Accuracy With Multiple Microorganisms	1
Evaluating Misclassification Effects on Single Sequential Treatment in Sequential Multiple Assignment Randomized Trial (SMART) Designs	1
Statistical Innovation in Healthcare: Celebrating the Past 40 Years and Looking Toward the Future–Special Issue for the 2021 Regulatory-Industry Statistics Workshop	1
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	1
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	1
Selecting an Optimal Design for a Non-randomized Comparative Study: A Comment on “Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Utilizing Propensity Score Method	1
Efficiency Comparison of Analysis Methods for Recurrent Event and Time-to-First Event Endpoints in the Presence of Terminal Events—Application to Clinical Trials in Chronic Heart Failure	1
The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions	1
From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis Principle for Time-to-Event Endpoint in Randomized Clinical Trials with Subgroups	1
A Statistical Method for Protocol Modifications With Heterogeneous Population Variances	1
Some Group Sequential Trials from Industry over the Last 30 Years	1
Comment on “Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group”: The Test Statistic Should Estimate Some Reasonable Meas	1
Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics	1
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift	1
Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation	1
Comment on “Good Data Science Practice: Moving towards a Code of Practice for Drug Development”	1
Nonproportional Hazards—An Evaluation of the MaxCombo Test in Cancer Clinical Trials	1
Straightforward Phase I Dose-Finding Design for Healthy Volunteers Accounting for Surrogate Activity Biomarkers	1
Least Conservative Critical Boundaries of Multiple Hypothesis Testing in a Range of Correlation Values	1
Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	1
A Generalized Framework of Optimal Two-Stage Designs for Exploratory Basket Trials	1
On the Implementation of Robust Meta-Analytical-Predictive Prior	1
Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment	1
Statistical Inference on the Estimators of the Adherer Average Causal Effect	1
Qualitative versus Quantitative Treatment-by-Subgroup Interaction in Equivalence Studies with Multiple Subgroups	1
Exact Properties of Some Heteroscedastic TOST Alternatives for Bioequivalence	1
Statistical Observations on Vaccine Clinical Development for Pandemic Diseases	1
A Simulation Study on the Estimation of the Effect in the Hypothetical Scenario of No Use of Symptomatic Treatment in Trials for Disease-Modifying Agents for Alzheimer’s Disease	1
The Strong Null Hypothesis and the MaxCombo Test: Comment on “Robust Design and Analysis of Clinical Trials with Nonproportional Hazards: A Straw Man Guidance form a Cross-Pharma Working Group.”	1
Predicting the COVID-19 Pandemic Impact on Clinical Trial Recruitment	1
Beyond the Cox Hazard Ratio: A Targeted Learning Approach to Survival Analysis in a Cardiovascular Outcome Trial Application	1
Using Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect	1
Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies	1
Applying Quantitative Approaches in the Use of RWE in Clinical Development and Life-Cycle Management	1