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 2022-05-01 to 2026-05-01.)

Article	Citations
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs	42
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials	25
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	18
Considerations on Interim Evaluation of OS in Pivotal Oncology Trials	17
Treatment Selection at Interim Analysis Based on a Correlated Early Endpoint in Adaptive Two-Stage Trials with a Primary Endpoint Based on Count Data	16
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies	14
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility	13
Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints	12
An Enhanced Doubly Robust Causal Estimator for Nonrandomized Trials with Binary Outcome	11
The Current Landscape of HTA Framework and Key Challenges	11
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective	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	10
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types	9
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction	9
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions	9
A Basket Trial Design Based on Power Priors	8
A Bayesian Latent Subgroup Design for Basket Trials with Survival Endpoints	7
Some Group Sequential Trials from Industry over the Last 30 Years	7
Statistical Considerations and Challenges for Pivotal Clinical Studies of Artificial Intelligence Medical Tests for Widespread Use: Opportunities for Inter-Disciplinary Collaboration	7
Optimizing Pediatric Dose Finding: A Phase I/II Design Integrating Adult Data	7
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design	7
Backward Sequential Significance Testing in Survival Trials	7
Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events	7

Augmenting the Control Arm of Randomized Trials by Incorporating Multiple External Data Sources Using Propensity Score Stratification and Data-Driven Mixture Prior	7
LORDs: Locally Optimal Restricted Designs for Phase I/II Dose-Finding Studies	7
Closing a Chapter: A Farewell from the Editor of Statistics in Biopharmaceutical Research	7
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift	7
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
Pre-Specified Safety Analysis of OS Data for Trials in Indolent or Early-Stage Cancers	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
Novel Statistical Designs and Considerations to Support Diversity and Inclusion in Clinical Trials	6
Information borrowing in Bayesian clinical trials: choice of tuning parameters for the robust mixture prior	6
Statistics in Biopharmaceutical Research Best Papers Award 2023	6
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group	6
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?	5
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials	5
Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”	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
Statistical Thinking and Innovation with Global Impact—Special Issue for the 2023 Regulatory-Industry Statistics Workshop	4
Estimating treatment efficacy controlling for subsequent therapy usage: comparison of multiple methods and application to hematologic oncology trials	4
On Variance Estimation for the One-Sample Log-Rank Test	4
A Primer of Quasi-Exact Tests for Randomized Clinical Trials with Binary Endpoints	4
Treatment-Control Comparisons in Platform Trials Including Non-Concurrent Controls	4
Rejoinder to Commentaries on the “Monitoring OS in Pivotal Trials in Indolent Cancers” Article	4
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development	4
Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial	4
Adaptive Endpoints Selection with Application in Rare Disease	4
Comment on “Monitoring Overall Survival in Pivotal Trials in Indolent Cancers”	4
Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials	3
A Rényi-Divergence-Based Family of Metrics for the Evaluation of Surrogate Endpoints in a Causal Inference Framework	3
The Use of Machine Learning in Regulatory Drug Safety Evaluation	3
A Comprehensive Bayesian Approach to Quantify and Compare Benefit-Risk of Medical Products	3
An Alternative to Traditional Sample Size Determination for Small Patient Populations	3
A Comparison of Estimand and Estimation Strategies for Clinical Trials in Early Parkinson’s Disease	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
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing	3
Correction	3
Multiplicity Control in Clinical Trials with Adaptive Selection Followed by Group-Sequential Testing	3
Random Effects Meta-Analysis of Contingency Tables with Complete and Partially Complete Data, with Application to COVID-19 Research	3
Inverse Probability of Treatment Weighting: A Simple and Effective Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	3
Causal Machine Learning Approaches for Adjusting Treatment Switching in Clinical Trials	3
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials	3
A Multi-Arm Multi-Stage Group Sequential Phase 2/3 Design with Dose Selection for Oncology Trials	3
A Graphical Framework for Testing Hierarchically Structured Hypothesis Families	3