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 2021-08-01 to 2025-08-01.)

Article	Citations
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	30
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing	21
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	19
Statistical Inference of the Probability of Passing the USP Dissolution Test	14
Treatment Selection at Interim Analysis Based on a Correlated Early Endpoint in Adaptive Two-Stage Trials with a Primary Endpoint Based on Count Data	14
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types	11
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction	11
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility	10
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	10
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	10
The Current Landscape of HTA Framework and Key Challenges	10
A Basket Trial Design Based on Power Priors	9
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	9
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints	9
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	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
Statistics in Biopharmaceutical Research Best Papers Award 2023	8
Backward Sequential Significance Testing in Survival Trials	8
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	8
Exact Matching as an Alternative to Propensity Score Matching	8
Some Group Sequential Trials from Industry over the Last 30 Years	8
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	8
Bayesian Hierarchical Model with Adaptive Similarity Evaluation of Treatment Effects in Oncology Basket Trials	8
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	8
Closing a Chapter: A Farewell from the Editor of Statistics in Biopharmaceutical Research	7

MT-Keyboard: A Bayesian Model-Assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials	7
Statistical Issues and Challenges in Clinical Trials for COVID-19 Treatments, Vaccines, Medical Devices and Diagnostics	7
A New Centralized Statistical Monitoring Method for Detecting Atypical Distribution of Qualitative Variables in Multicenter Randomized Controlled Trials	7
Reference-Based Multiple Imputation—What is the Right Variance and How to Estimate It	7
Our Most Important Discovery: The Question	6
A Comparison of Different Approaches to Bayesian Hierarchical Models in a Basket Trial to Evaluate the Benefits of Increasing Complexity	6
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials	6
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group	6
A Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design with Efficacy Interim Analysis When Slope Is the Primary Endpoint	5
Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”	5
Editor’s Note	5
Properties of Two While-Alive Estimands for Recurrent Events and Their Potential Estimators	5
Treatment-Control Comparisons in Platform Trials Including Non-Concurrent Controls	5
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?	5
Bayesian Basket Trial Design Accounting for Multiple Cutoffs of an Ambiguous Biomarker	5
Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial	5
Adaptive Endpoints Selection with Application in Rare Disease	5
Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments	4
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development	4
A Primer of Quasi-Exact Tests for Randomized Clinical Trials with Binary Endpoints	4
Statistical Thinking and Innovation with Global Impact—Special Issue for the 2023 Regulatory-Industry Statistics Workshop	4
Comment on “Monitoring Overall Survival in Pivotal Trials in Indolent Cancers”	3
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	3
On Variance Estimation for the One-Sample Log-Rank Test	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
Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies	3
Bayesian Optimal Phase II Design for Randomized Clinical Trials	3
Correction	3
Multiarmed Bandit Designs for Phase I Dose-Finding Clinical Trials With Multiple Toxicity Types	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
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in 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
Random Effects Meta-Analysis of Contingency Tables with Complete and Partially Complete Data, with Application to COVID-19 Research	3
Rejoinder to Commentaries on the “Monitoring OS in Pivotal Trials in Indolent Cancers” Article	3
The Use of Machine Learning in Regulatory Drug Safety Evaluation	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
An Alternative to Traditional Sample Size Determination for Small Patient Populations	3
The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions	3
Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials	3