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 2022-08-01 to 2026-08-01.)

Article	Citations
Treatment Selection at Interim Analysis Based on a Correlated Early Endpoint in Adaptive Two-Stage Trials with a Primary Endpoint Based on Count Data	27
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing	22
Considerations on Interim Evaluation of OS in Pivotal Oncology Trials	18
A Landscape Assessment of Key Evidence Needs in Study Design and Statistical Methodologies for HTA Submissions	18
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	16
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	16
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	14
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
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
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”	10
A Cautionary Note on E-Values Using Biased Risk Ratio Approximations from Hazard Ratios	9
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	8
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	8
The Current Landscape of HTA Framework and Key Challenges	8
Some Group Sequential Trials from Industry over the Last 30 Years	8
A Basket Trial Design Based on Power Priors	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
Optimizing Pediatric Dose Finding: A Phase I/II Design Integrating Adult Data	7
A Bayesian Latent Subgroup Design for Basket Trials with Survival Endpoints	7
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	7
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	7

Augmenting the Control Arm of Randomized Trials by Incorporating Multiple External Data Sources Using Propensity Score Stratification and Data-Driven Mixture Prior	7
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	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
Backward Sequential Significance Testing in Survival Trials	6
Statistics in Biopharmaceutical Research Best Papers Award 2023	6
Closing a Chapter: A Farewell from the Editor of Statistics in Biopharmaceutical Research	6
MT-Keyboard: A Bayesian Model-Assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials	6
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials	5
Navigating Priorities, Statistical Rigor, and Decision-Making on Multiplicity Questions in the Context of the EU Joint Clinical Assessment	5
Novel Statistical Designs and Considerations to Support Diversity and Inclusion in Clinical Trials	5
Information Borrowing in Bayesian Clinical Trials: choice of Tuning Parameters for the Robust Mixture Prior	5
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group	5
Exact Matching as an Alternative to Propensity Score Matching	5
Pre-Specified Safety Analysis of OS Data for Trials in Indolent or Early-Stage Cancers	5
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 Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design with Efficacy Interim Analysis When Slope Is the Primary Endpoint	4
A Primer of Quasi-Exact Tests for Randomized Clinical Trials with Binary Endpoints	4
Adaptive Endpoints Selection with Application in Rare Disease	4
Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial	4
Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”	4
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?	4
Estimating Treatment Efficacy Controlling for Subsequent Therapy Usage: Comparison of Multiple Methods and Application to Hematologic Oncology Trials	4
BOOST: An Adaptive Biomarker-Guided Simon Two-Stage Design with Explicit Control of Pooled and Subgroup Inference	3
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials	3
An Alternative to Traditional Sample Size Determination for Small Patient Populations	3
A Comprehensive Bayesian Approach to Quantify and Compare Benefit-Risk of Medical Products	3
A Multi-Arm Multi-Stage Group Sequential Phase 2/3 Design with Dose Selection for Oncology Trials	3
The Use of Machine Learning in Regulatory Drug Safety Evaluation	3
Rejoinder to Commentaries on the “Monitoring OS in Pivotal Trials in Indolent Cancers” Article	3
OFGSD: Optimal Futility Stopping Rules for Group Sequential Design	3
Editor’s Note	3
Inverse Probability of Treatment Weighting: A Simple and Effective Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	3
The NISS Ingram Olkin Forum on Unplanned Clinical Trial Disruptions	3
Multiplicity Control in Clinical Trials with Adaptive Selection Followed by Group-Sequential Testing	3
Correction	3
Treatment-Control Comparisons in Platform Trials Including Non-Concurrent Controls	3
Comparison of Methods to Analyze Time-to-Event Endpoints When Treatment Effect is Delayed	3
Challenges of Modeling Biomarker Effects on Time-to-Event Outcomes	3
A Graphical Framework for Testing Hierarchically Structured Hypothesis Families	3
A Bayesian Design with Efficient Backfilling and Expansion to Accelerate Phase I/II Trials Accommodating Late-Onset Competing Risk Outcomes	3
Causal Machine Learning Approaches for Adjusting Treatment Switching in Clinical Trials	3
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	3
Comment on “Monitoring Overall Survival in Pivotal Trials in Indolent Cancers”	3
Statistical Innovation for Integrated Evidence in Medical Product Development	3