OOIR: Observatory of International 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 2021-05-01 to 2025-05-01.)

Article	Citations
Composite Endpoints in Cardio-Renal Clinical Outcome Trials	26
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing	19
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	19
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	17
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion	15
Statistical Inference of the Probability of Passing the USP Dissolution Test	14
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints	13
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	11
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility	11
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types	9
The current landscape of HTA framework and key challenges	9
A Basket Trial Design Based on Power Priors	9
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”	9
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction	8
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	8
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	7
Statistics in Biopharmaceutical Research Best Papers Award 2023	7
Some Group Sequential Trials from Industry over the Last 30 Years	7
On the Implementation of Robust Meta-Analytical-Predictive Prior	7
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	7
Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics	7
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	7
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	7
Backward Sequential Significance Testing in Survival Trials	7
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	7

A New Centralized Statistical Monitoring Method for Detecting Atypical Distribution of Qualitative Variables in Multicenter Randomized Controlled Trials	6
Bayesian Hierarchical Model with Adaptive Similarity Evaluation of Treatment Effects in Oncology Basket Trials	6
Reference-Based Multiple Imputation—What is the Right Variance and How to Estimate It	6
MT-Keyboard: A Bayesian Model-Assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials	6
Properties of Two While-Alive Estimands for Recurrent Events and Their Potential Estimators	6
A Comparison of Different Approaches to Bayesian Hierarchical Models in a Basket Trial to Evaluate the Benefits of Increasing Complexity	5
A Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design with Efficacy Interim Analysis When Slope Is the Primary Endpoint	5
Adaptive Endpoints Selection with Application in Rare Disease	5
Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial	5
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group	5
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials	5
A Primer of Quasi-Exact Tests for Randomized Clinical Trials with Binary Endpoints	5
Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”	5
Our Most Important Discovery: The Question	5
Editor’s Note	5
Bayesian Basket Trial Design Accounting for Multiple Cutoffs of an Ambiguous Biomarker	5
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?	5
Treatment-control comparisons in platform trials including non-concurrent controls	4
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	4
The Use of Machine Learning in Regulatory Drug Safety Evaluation	4
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments	4
Correction	4
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development	4
On Variance Estimation for the One-Sample Log-Rank Test	4
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types	4
Comment on “Monitoring Overall Survival in Pivotal Trials in Indolent Cancers”	3
Rejoinder to Commentaries on the “Monitoring OS in Pivotal Trials in Indolent Cancers” Article	3
Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”: Is Real-World Evidence Real?	3
Applying Quantitative Approaches in the Use of RWE in Clinical Development and Life-Cycle Management	3
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	3
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	3
Bayesian Optimal Phase II Design for Randomized Clinical Trials	3
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	3
Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies	3
The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions	3
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials	3
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	3
An Alternative to Traditional Sample Size Determination for Small Patient Populations	3
Random Effects Meta-Analysis of Contingency Tables with Complete and Partially Complete Data, with Application to COVID-19 Research	3