Statistics in Biopharmaceutical 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.)
ArticleCitations
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 Ensembles31
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 Development21
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types16
Combined Tests Based on Restricted Mean Time Lost for Competing Risks Data15
Eliciting the Discount Parameter in a Power Prior Method on the Basis of the Type I Error Consideration14
Similarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond14
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion14
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs13
Composite Endpoints in Cardio-Renal Clinical Outcome Trials12
On Variance Estimation for the One-Sample Log-Rank Test11
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments11
A Test for Treatment Effects Based on the Exact Distribution of an Ordinary Least-Square Estimator in Sequential Parallel Comparison Design10
Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators10
Leveraging Real-World Data in COVID-19 Response9
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
Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation8
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 Disruptions7
Selected Articles from the Nonclinical Biostatistics Conference 20217
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing7
Editor’s Note: Special Section on Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes7
Three-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement7
A Modification of Location Commensurate Power Prior in Clinical Trials7
The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis6
A Composite Endpoint for Treatment Benefit According to Patient Preference6
The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis6
Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring6
A Unified Three-State Model Framework for Analysis of Treatment Crossover in Survival Trials6
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial6
The Use of Machine Learning in Regulatory Drug Safety Evaluation6
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing5
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics5
Implementation of Statistical Innovation in a Pharmaceutical Company5
Dose Optimization for Novel Oncology Agents: Design Options and Strategies5
Correction5
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow5
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials5
A Method for Ensuring a Consistent Dose–Response Relationship Between An Entire Population and One Region in Multiregional Dose–Response Studies Using MCP-Mod5
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
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies4
Teasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments4
A Basket Trial Design Based on Power Priors4
Editor’s Note4
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility4
Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group4
Editor’s Note4
The 2019 Nonclinical Biostatistics Conference4
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials4
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
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 Stu4
A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic3
Statistical Inference of the Probability of Passing the USP Dissolution Test3
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types3
Two-Stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers3
Examples of Applying RWE Causal-Inference Roadmap to Clinical Studies3
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints3
Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes3
Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints3
Post-Test Diagnostic Accuracy Measures of a Continuous Test With a Disease of Ordinal Multistages3
Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence3
Probability of Study Success (PrSS) Evaluation Based on Multiple Endpoints in Late Phase Oncology Drug Development3
Special Issue for Selected Articles From the ISBS2019: Statistical Innovation and Contribution in the Era of Precision Healthcare3
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions3
The Targeted Virtual Control Approach for Single-Arm Clinical Trials with External Controls3
Possible Data-Generating Models of Longitudinal Continuous Outcomes and Intercurrent Events to Investigate Estimands3
Enhancement of Basket Trial Designs with Incorporation of a Bayesian Three-Outcome Decision-Making Framework3
Quantifying Replicability and Consistency in Systematic Reviews3
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 St2
Bayesian shrinkage estimation of credible subgroups for count data with excess zeros2
Efficient Estimation of the Efficacy and Safety Endpoints for Clinical Trials with Preplanned Dose Titrations2
Adjusting for Time-Varying Treatment Switches in Randomized Clinical Trials: The Danger of Extrapolation and How to Address It2
Comparing Dose Levels to Placebo using a Continuous Outcome in a Small n, Sequential, Multiple Assignment, Randomized trial (snSMART)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 Trials2
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration2
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective2
Combining Recurrent and Terminal Events Into a Composite Endpoint May Be Problematic2
Comparison of Adverse Event Risks in Randomized Controlled Trials with Varying Follow-Up Times and Competing Events: Results from an Empirical Study2
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events2
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction2
Some Biostatistical Considerations About Real-World Data and Evidence in Clinical Studies, Especially for Regulatory Purposes2
Developing a Targeted Learning-Based Statistical Analysis Plan2
Minimizing Selection Bias Under the Blackwell and Hodges Model with an Equal Allocation Procedure in a Symmetric Allocation Space2
A Note on Stratification Errors in the Analysis of Clinical Trials2
Comparison of Sample Size Requirements of Randomized and Historically Controlled Trials Based on Calibrated Error Rates2
Deep Learning Based Multimodal Progression Modeling for Alzheimer’s Disease2
Rejoinder to the Commentaries on “The Current Landscape in Biostatistics of Real-World Data and Evidence: Label Expansion”2
Validity of Tests for Time-to-Event Endpoints in Studies with the Pocock and Simon Covariate-Adaptive Randomization2
Bayesian Optimal Phase II Design for Randomized Clinical Trials2
Quick Multiple Test Procedures and p-Value Adjustments2
Distribution of a P-Value When the Alternative Hypothesis is True for Binary Outcomes2
Establishing and Using Threshold of Surrogate Endpoint in Relation to Clinical Endpoint2
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 Meas1
Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics1
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift1
Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation1
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 Trials1
Straightforward Phase I Dose-Finding Design for Healthy Volunteers Accounting for Surrogate Activity Biomarkers1
Least Conservative Critical Boundaries of Multiple Hypothesis Testing in a Range of Correlation Values1
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 Disruptions1
A Generalized Framework of Optimal Two-Stage Designs for Exploratory Basket Trials1
On the Implementation of Robust Meta-Analytical-Predictive Prior1
Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment1
Statistical Inference on the Estimators of the Adherer Average Causal Effect1
Qualitative versus Quantitative Treatment-by-Subgroup Interaction in Equivalence Studies with Multiple Subgroups1
Exact Properties of Some Heteroscedastic TOST Alternatives for Bioequivalence1
Statistical Observations on Vaccine Clinical Development for Pandemic Diseases1
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 Disease1
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 Recruitment1
Beyond the Cox Hazard Ratio: A Targeted Learning Approach to Survival Analysis in a Cardiovascular Outcome Trial Application1
Using Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect1
Applying Quantitative Approaches in the Use of RWE in Clinical Development and Life-Cycle Management1
Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies1
Bayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes1
A Flexible Analytical Framework for Reference-Based Imputation, Delta Adjustment and Tipping-Point Stress-Testing1
An Alternative to Traditional Sample Size Determination for Small Patient Populations1
Unsupervised Imputation of Non-Ignorably Missing Data Using Importance-Weighted Autoencoders1
Combining Real-World and Randomized Control Trial Data Using Data-Adaptive Weighting via the On-Trial Score1
Rejoinder1
Dynamic Monitoring of Ongoing Clinical Trials1
Bayesian Design of Superiority Trials: Methods and Applications1
Bayesian Borrowing Methods for Count Data: Analysis of Incontinence Episodes in Patients with Overactive Bladder1
Optimal Spiking Experiment for Noninferiority of Qualitative Microbiological Methods on Accuracy With Multiple Microorganisms1
Evaluating Misclassification Effects on Single Sequential Treatment in Sequential Multiple Assignment Randomized Trial (SMART) Designs1
Statistical Innovation in Healthcare: Celebrating the Past 40 Years and Looking Toward the Future–Special Issue for the 2021 Regulatory-Industry Statistics Workshop1
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift1
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 Method1
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design1
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 Failure1
The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions1
From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis Principle for Time-to-Event Endpoint in Randomized Clinical Trials with Subgroups1
A Statistical Method for Protocol Modifications With Heterogeneous Population Variances1
Some Group Sequential Trials from Industry over the Last 30 Years1
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