OOIR: Observatory of International Research

Papers

(The TQCC of Pharmaceutical Statistics 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 2021-11-01 to 2025-11-01.)

Article	Citations
Frailty model with change points for survival analysis	39
Generalizing Treatment Effect to a Target Population Without Individual Patient Data in a Real‐World Setting	25
Prediction Intervals for Overdispersed Binomial Endpoints and Their Application to Toxicological Historical Control Data	22
Pre‐Posterior Distributions in Drug Development and Their Properties	19
Average Hazard as Harmonic Mean	18
A Likelihood Perspective on Dose‐Finding Study Designs in Oncology	18
Using an early outcome as the sole source of information of interim decisions regarding treatment effect on a long‐term endpoint: The non‐Gaussian case	17
Improved inference forMCP‐Modapproach using time‐to‐event endpoints with small sample sizes	16
	14
A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials	14
Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy	14
CUSUMIN: A cumulative sum interval design for cancer phase I dose finding studies	13
Issue Information	13
Improving early phase oncology clinical trial design: The case for finding the optimal biological dose	13
Control of Unconditional Type I Error in Clinical Trials With External Control Borrowing—A Two‐Stage Adaptive Design Perspective	12
A Model‐Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology	12
Why “Minimal Clinically Important Difference” for Interpreting the Magnitude of the Treatment Effect Is Not Useful	11
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	10
To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines	10
Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior	10
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery	10
A meta‐analytic framework to adjust for bias in external control studies	9
A conservative approach to leveraging external evidence for effective clinical trial design	9
Extending Multiple Testing With Unknown Test Dependency via the CoCo Test: With Applications to Cancer Studies	8
Applying the Estimand Framework to Non‐Inferiority Trials	8

Information‐based group sequential design for post‐market safety monitoring of medical products using real world data	8
Incorporating historical information to improve dose optimization design with toxicity and efficacy endpoints: iBOIN‐ET	8
From innovative thinking to pharmaceutical industry implementation: Some success stories	7
Simultaneous Inference Using Multiple Marginal Models	7
Estimation of a treatment policy estimand for time to event data using data collected post discontinuation of randomised treatment	7
A MCP‐Mod approach to designing and analyzing survival trials with potential non‐proportional hazards	7
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	7
Quantification of follow‐up time in oncology clinical trials with a time‐to‐event endpoint: Asking the right questions	7
Current developments of the estimand concept	7
Finding the Optimal Number of Splits and Repetitions in Double Cross‐Fitting Targeted Maximum Likelihood Estimators	7
Simulation‐based sequential design	7
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components	7
Reflecting on Andy Grieve's influence and innovation: A personal perspective	6
Applying the Principal Stratum Strategy in Equivalence Trials: A Case Study	6
An evolutionary algorithm for the direct optimization of covariate balance between nonrandomized populations	6
Issue Information	6
	6
Interim decision making in seamless trial designs: An application in an adaptive dose‐finding study in a rare kidney disease	6
BOIN‐MEM: A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Oncology Phase I/II Trials	6
An illness–death multistate model to implement delta adjustment and reference‐based imputation with time‐to‐event endpoints	6
Chauhan Weighted Trajectory Analysis of Combined Efficacy and Safety Outcomes for Risk–Benefit Analysis	6
Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment	6
Should responder analyses be conducted on continuous outcomes?	5
Study‐design in pandemics: From surveillance and performance‐evaluation to licensing and pharmacovigilance	5
Frequentist and Bayesian tolerance intervals for setting specification limits for left‐censored gamma distributed drug quality attributes	5
Balance diagnostics in propensity score analysis following multiple imputation: A new method	5
Statistical methods for handling missing data to align with treatment policy strategy	5
Estimation of Treatment Policy Estimands for Continuous Outcomes Using Off‐Treatment Sequential Multiple Imputation	5
The Wilcoxon–Mann–Whitney Estimand Versus Differences in Medians or Means	5
	5
Bayesian borrowing from historical control data in a vaccine efficacy trial	5
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space	5
A Bayesian Hybrid Design With Borrowing From Historical Study	4
Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data	4
Issue Information	4
Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide	4
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What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	4
Geometric approaches to assessing the numerical feasibility for conducting matching‐adjusted indirect comparisons	4
Beyond the Fragility Index	4
Evaluating hybrid controls methodology in early‐phase oncology trials: A simulation study based on the MORPHEUS‐UC trial	4
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials	4
A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian Process Regression	4
CUSUMIN Combination: A Cumulative Sum Interval Design for Phase I Cancer Drug‐Combination Trials	4
Propensity score matching and stratification using multiparty data without pooling	4
Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan	4
Improving precision and power in randomized trials with a two‐stage study design: Stratification using clustering method	4
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Issue Information	3
Bayesian optimal phase II designs with dual‐criterion decision making	3

Using Propensity Score Weighting to Enhance the Operating Characteristics of Power Prior in Leveraging External Data to Augment a Traditional Clinical Study	3
Issue Information	3
Time‐to‐event estimands and loss to follow‐up in oncology in light of the estimands guidance	3
Applying Bias Correction Methods to Build Hybrid Controls Using Real‐World Patients for a Phase IIb Randomized Controlled Trial of Baricitinib for Rheumatoid Arthritis	3
Dynamic borrowing of historical controls adjusting for covariates in vaccine efficacy clinical trials	3
Response to the letter to the editor regarding our article ‘statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study’ https://doi.	3
Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study	3
Issue Information	3
Type‐I‐error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications	3
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials	3
	3
Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks	3
An adaptive biomarker basket design in phase II oncology trials	3
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	3
An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial	3
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	3
Improving the assessment of the probability of success in late stage drug development	3
	3
The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact	3
Adaptively leveraging external data with robust meta‐analytical‐predictive prior using empirical Bayes	2
A Tipping Point Method to Evaluate Sensitivity to Potential Violations in Missing Data Assumptions	2
Inclusion of binary proxy variables in logistic regression improves treatment effect estimation in observational studies in the presence of binary unmeasured confounding variables	2
The design and analysis of vaccine trials for COVID‐19 for the purpose of estimating efficacy	2
Application of hypothetical strategies in acute pain	2
Confidence intervals for point‐of‐stabilization of content uniformity	2
Two‐stage subgroup‐specific time‐to‐event (2S‐Sub‐TITE): An adaptive two‐stage time‐to‐toxicity design for subgroup‐specific dose finding in phase I oncology trials	2
Alone, together: On the benefits of Bayesian borrowing in a meta‐analytic setting	2
Comments on “Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study”	2
Sample Size Estimation for Correlated Count Data With Changes in Dispersion	2
A Commensurate Prior Model With Random Effects for Survival and Competing Risk Outcomes to Accommodate Historical Controls	2
Variable Duration Trial as an Alternative Design for Continuous Endpoints	2
Quality by Design for Preclinical In Vitro Assay Development	2
Group sequential design with maximin efficiency robust test for immunotherapy with generalized delayed treatment effect	2
The Estimand Framework and Causal Inference: Complementary Not Competing Paradigms	2
Comparing various Bayesian random‐effects models for pooling randomized controlled trials with rare events	2
Issue Information	2
	2
Should the two‐trial paradigm still be the gold standard in drug assessment?	2
Statistical analysis of actigraphy data with generalised additive models	2
Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach	2
Potential Bias Models With Bayesian Shrinkage Priors for Dynamic Borrowing of Multiple Historical Control Data	2
Rejoinder to the letter: “Standard and reference‐based conditional mean imputation: Regulators and trial statisticians be aware!”	2
Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials	2
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	2
Web based resource for Statistical Consultants in the Pharmaceutical Industry	2
On the use of extreme value tail modeling for generalized pairwise comparisons with censored outcomes	2
Principles for Defining Estimands in Clinical Trials—A Proposal	2
On the relative conservativeness of Bayesian logistic regression method in oncology dose‐finding studies	2
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors	2
Investigating Stability in Subgroup Identification for Stratified Medicine	2
Introduction to Nonclinical Biopharmaceutical Statistics Tutorials—A Special Issue	2
Visualizing hypothesis tests in survival analysis under anticipated delayed effects	2
A note on point estimation and interval estimation of the relative treatment effect under a simple crossover design	2
Estimation of multivariate treatment effects in contaminated clinical trials	2
Transporting randomized trial results to estimate counterfactual survival functions in target populations	2
Predictive Ppk calculations for biologics and vaccines using a Bayesian approach – a tutorial	2
Sample Size Estimation Using a Partially Clustered Frailty Model for Biomarker‐Strategy Designs With Multiple Treatments	2
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Just say no to data listings!	2
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