Statistics in Biopharmaceutical Research

Papers
(The TQCC of Statistics in Biopharmaceutical Research is 3. 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 2021-01-01 to 2025-01-01.)
ArticleCitations
Editorial: Roles of Hypothesis Testing, p-Values and Decision Making in Biopharmaceutical Research34
Rejoinder to Commentaries on “Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event”31
A Closer Look at the Kernels Generated by the Decision and Regression Tree Ensembles25
Good Data Science Practice: Moving toward a Code of Practice for Drug Development (Rejoinder)21
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 Development16
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types15
Editorial Collaborators14
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion14
Combined Tests Based on Restricted Mean Time Lost for Competing Risks Data14
Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”13
Similarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond12
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics11
Implementation of Statistical Innovation in a Pharmaceutical Company11
Eliciting the Discount Parameter in a Power Prior Method on the Basis of the Type I Error Consideration10
A Method for Ensuring a Consistent Dose–Response Relationship Between An Entire Population and One Region in Multiregional Dose–Response Studies Using MCP-Mod10
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs9
On Variance Estimation for the One-Sample Log-Rank Test8
Composite Endpoints in Cardio-Renal Clinical Outcome Trials8
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments7
Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation7
A Test for Treatment Effects Based on the Exact Distribution of an Ordinary Least-Square Estimator in Sequential Parallel Comparison Design7
Comment on “Randomization Tests to Address Disruptions in Clinical Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions”7
Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators7
Leveraging Real-World Data in COVID-19 Response7
Editor’s Note: Special Section on Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes6
Three-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement6
A Modification of Location Commensurate Power Prior in Clinical Trials6
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing6
The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis6
Selected Articles from the Nonclinical Biostatistics Conference 20216
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial6
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 Disruptions6
A Unified Three-State Model Framework for Analysis of Treatment Crossover in Survival Trials5
Dose Optimization for Novel Oncology Agents: Design Options and Strategies5
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials5
The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis5
A Composite Endpoint for Treatment Benefit According to Patient Preference5
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing5
Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring5
The Use of Machine Learning in Regulatory Drug Safety Evaluation5
Correction5
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
p-Value, Hypothesis Testing, Strength of Evidence: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”4
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials4
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
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies4
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow4
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
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility4
A Basket Trial Design Based on Power Priors4
Teasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments3
Statistical Inference of the Probability of Passing the USP Dissolution Test3
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”3
Waking up to p: Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”3
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
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types3
Editor’s Note3
The p-Value: Guilty by Association3
A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic3
Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints3
Quantifying Replicability and Consistency in Systematic Reviews3
Two-Stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers3
Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes3
Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”: Is Real-World Evidence Real?3
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
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple 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
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