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 2021-04-01 to 2025-04-01.)
ArticleCitations
A Method for Ensuring a Consistent Dose–Response Relationship Between An Entire Population and One Region in Multiregional Dose–Response Studies Using MCP-Mod19
Implementation of Statistical Innovation in a Pharmaceutical Company18
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics18
Rejoinder to Commentaries on “Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event”17
A Closer Look at the Kernels Generated by the Decision and Regression Tree Ensembles15
Good Data Science Practice: Moving toward a Code of Practice for Drug Development (Rejoinder)14
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 Development14
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types13
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing11
Similarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond10
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 Disruptions9
Eliciting the Discount Parameter in a Power Prior Method on the Basis of the Type I Error Consideration9
Composite Endpoints in Cardio-Renal Clinical Outcome Trials9
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments8
Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators8
Formulating three classes of partial borrowing power priors to leverage historical data in process validation7
A Modification of Location Commensurate Power Prior in Clinical Trials7
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
Three-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement7
Selected Articles from the Nonclinical Biostatistics Conference 20217
Leveraging Real-World Data in COVID-19 Response7
A Unified Three-State Model Framework for Analysis of Treatment Crossover in Survival Trials7
An Unbiased Method to Approximate a Principal Estimand7
Editor’s Note: Special Section on Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes7
A Test for Treatment Effects Based on the Exact Distribution of an Ordinary Least-Square Estimator in Sequential Parallel Comparison Design7
On Variance Estimation for the One-Sample Log-Rank Test6
A Composite Endpoint for Treatment Benefit According to Patient Preference6
Combined Tests Based on Restricted Mean Time Lost for Competing Risks Data6
Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation6
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial6
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs6
Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring6
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow5
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion5
Dose Optimization for Novel Oncology Agents: Design Options and Strategies5
Time-to-event Estimands in Oncology Trials: What’s Censoring Got To Do, Got To Do With It?5
Correction5
The Use of Machine Learning in Regulatory Drug Safety Evaluation5
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing5
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials5
Direct Estimation for Commonly Used Pattern-Mixture Models in Clinical Trials5
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
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility4
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
The 2019 Nonclinical Biostatistics Conference4
Editor’s Note4
A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic4
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
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies4
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials4
Validity of Tests for Time-to-Event Endpoints in Studies with the Pocock and Simon Covariate-Adaptive Randomization3
The Targeted Virtual Control Approach for Single-Arm Clinical Trials with External Controls3
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints3
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types3
Special Issue for Selected Articles From the ISBS2019: Statistical Innovation and Contribution in the Era of Precision Healthcare3
Quick Multiple Test Procedures and p-Value Adjustments3
Enhancement of Basket Trial Designs with Incorporation of a Bayesian Three-Outcome Decision-Making Framework3
Probability of Study Success (PrSS) Evaluation Based on Multiple Endpoints in Late Phase Oncology Drug Development3
Teasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments3
Minimizing Selection Bias Under the Blackwell and Hodges Model with an Equal Allocation Procedure in a Symmetric Allocation Space3
Editor’s Note3
Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence3
Two-Stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers3
Statistical Inference of the Probability of Passing the USP Dissolution Test3
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