OOIR: Observatory of International Research

Papers

(The TQCC of Statistics in Biopharmaceutical Research is 2. 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 2022-06-01 to 2026-06-01.)

Article	Citations
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	42
Treatment Selection at Interim Analysis Based on a Correlated Early Endpoint in Adaptive Two-Stage Trials with a Primary Endpoint Based on Count Data	26
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	20
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing	18
A Landscape Assessment of Key Evidence Needs in Study Design and Statistical Methodologies for HTA Submissions	17
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	16
Considerations on Interim Evaluation of OS in Pivotal Oncology Trials	16
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints	14
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types	13
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	12
The Current Landscape of HTA Framework and Key Challenges	12
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility	11
A Basket Trial Design Based on Power Priors	10
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	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	9
A Cautionary Note on E-Values Using Biased Risk Ratio Approximations from Hazard Ratios	8
An Enhanced Doubly Robust Causal Estimator for Nonrandomized Trials With Binary Outcome	8
LORDs: Locally Optimal Restricted Designs for Phase I/II Dose-Finding Studies	7
Augmenting the Control Arm of Randomized Trials by Incorporating Multiple External Data Sources Using Propensity Score Stratification and Data-Driven Mixture Prior	7
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	7
Some Group Sequential Trials from Industry over the Last 30 Years	7
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	7
Optimizing Pediatric Dose Finding: A Phase I/II Design Integrating Adult Data	7
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	7

A Bayesian Latent Subgroup Design for Basket Trials with Survival Endpoints	7
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	7
Backward Sequential Significance Testing in Survival Trials	7
Closing a Chapter: A Farewell from the Editor of Statistics in Biopharmaceutical Research	6
Statistics in Biopharmaceutical Research Best Papers Award 2023	6
Navigating Priorities, Statistical Rigor, and Decision-Making on Multiplicity Questions in the Context of the EU Joint Clinical Assessment	6
Bayesian Hierarchical Model with Adaptive Similarity Evaluation of Treatment Effects in Oncology Basket Trials	6
Exact Matching as an Alternative to Propensity Score Matching	6
Novel Statistical Designs and Considerations to Support Diversity and Inclusion in Clinical Trials	6
A New Centralized Statistical Monitoring Method for Detecting Atypical Distribution of Qualitative Variables in Multicenter Randomized Controlled Trials	6
MT-Keyboard: A Bayesian Model-Assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials	6
Information Borrowing in Bayesian Clinical Trials: choice of Tuning Parameters for the Robust Mixture Prior	6
Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”	5
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group	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
Pre-Specified Safety Analysis of OS Data for Trials in Indolent or Early-Stage Cancers	5
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials	5
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?	4
Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial	4
Estimating Treatment Efficacy Controlling for Subsequent Therapy Usage: Comparison of Multiple Methods and Application to Hematologic Oncology Trials	4
Statistical Thinking and Innovation with Global Impact—Special Issue for the 2023 Regulatory-Industry Statistics Workshop	4
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development	4
Bayesian and Frequentist Stratified Analysis of Treatment Effects with Survival Data in Comparative Trials	4
A Primer of Quasi-Exact Tests for Randomized Clinical Trials with Binary Endpoints	4
Adaptive Endpoints Selection with Application in Rare Disease	4
Editor’s Note	4
Causal Machine Learning Approaches for Adjusting Treatment Switching in Clinical Trials	3
A Graphical Framework for Testing Hierarchically Structured Hypothesis Families	3
On Variance Estimation for the One-Sample Log-Rank Test	3
Correction	3
Comparison of Methods to Analyze Time-to-Event Endpoints When Treatment Effect is Delayed	3
Multiplicity Control in Clinical Trials with Adaptive Selection Followed by Group-Sequential Testing	3
An Alternative to Traditional Sample Size Determination for Small Patient Populations	3
Inverse Probability of Treatment Weighting: A Simple and Effective Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	3
OFGSD: O ptimal F utility Stopping Rules for G roup	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
Challenges of Modeling Biomarker Effects on Time-to-Event Outcomes	3
A Multi-Arm Multi-Stage Group Sequential Phase 2/3 Design with Dose Selection for Oncology Trials	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
Treatment-Control Comparisons in Platform Trials Including Non-Concurrent Controls	3
Comment on “Monitoring Overall Survival in Pivotal Trials in Indolent Cancers”	3
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	3
A Comprehensive Bayesian Approach to Quantify and Compare Benefit-Risk of Medical Products	3
A Comparison of Estimand and Estimation Strategies for Clinical Trials in Early Parkinson’s Disease	2
Prevalence Estimation in Finite Populations Adjusted for Misclassification	2
A Quantitative Bias Analysis to Assess Constancy Assumption in Noninferiority Trials Using Bayesian Hierarchical Models	2
Commentary on “Statistical Methodology Groups in the Pharmaceutical Industry”	2
The Role of Statistical Thinking in Biopharmaceutical Research	2

Chasing Shadows: How Implausible Assumptions Skew Our Understanding of Causal Estimands	2
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	2
Targeted Learning: Toward a Future Informed by Real-World Evidence	2
A Rényi-Divergence-Based Family of Metrics for the Evaluation of Surrogate Endpoints in a Causal Inference Framework	2
Designing Dose-Optimization Studies in Cancer Drug Development: Discussions with Regulators	2
Rejoinder - Statistical Methodology Groups in the Pharmaceutical Industry ^#	2
Bayesian Estimation of Dynamic Treatment Regimens in a Partially Randomized Patient Preference, Sequential, Multiple-Assignment, Randomized Trial	2
Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies	2
Modified Robust Meta-Analytic-Predictive Priors for Incorporating Historical Controls in Clinical Trials	2
Subgroup Analyses in Confirmatory Clinical Trials Using Bayesian Hierarchical Models	2
Balancing the Objectives of Statistical Efficiency and Allocation Randomness in Randomized Controlled Trials	2
Random Effects Meta-Analysis of Contingency Tables with Complete and Partially Complete Data, with Application to COVID-19 Research	2
Use of Common Control Arms Across Substudies in a Master Protocol via Ridge Estimation	2
Evaluating the Impact of Outcome Delay on the Efficiency of Two-Arm Group-Sequential Trials	2
Dionne Price: An Esteemed Colleague, Inspirational Leader, Trailblazer Statistician and a Dear Friend	2
Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials	2
Vaccine Development during a Pandemic: General Lessons for Clinical Trial Design	2
Assessing Contribution of Treatment Phases through Tipping Point Analyses via Counterfactual Elicitation Using Rank Preserving Structural Failure Time Models	2
Non-Inferiority Testing on the Accuracy of Two Qualitative Microbiological Methods on Paired Binary Data	2