OOIR: Observatory of International Research

Papers

(The TQCC of Pharmaceutical Statistics 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 2021-12-01 to 2025-12-01.)

Article	Citations
Frailty model with change points for survival analysis	41
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
A Likelihood Perspective on Dose‐Finding Study Designs in Oncology	19
Pre‐Posterior Distributions in Drug Development and Their Properties	19
Average Hazard as Harmonic Mean	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
	15
A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials	15
A Weighted Geometric Average Hazard Ratio Based Sample Size Formula for Non‐Proportional Hazards and Its Application to a Smoothed Piecewise Model in Cancer Immunotherapy Trial Design	15
Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy	15
Issue Information	14
CUSUMIN: A cumulative sum interval design for cancer phase I dose finding studies	13
Improving early phase oncology clinical trial design: The case for finding the optimal biological dose	13
A Model‐Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology	12
Control of Unconditional Type I Error in Clinical Trials With External Control Borrowing—A Two‐Stage Adaptive Design Perspective	11
Why “Minimal Clinically Important Difference” for Interpreting the Magnitude of the Treatment Effect Is Not Useful	11
To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines	10
Information‐based group sequential design for post‐market safety monitoring of medical products using real world data	10
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery	10
A conservative approach to leveraging external evidence for effective clinical trial design	10
Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior	10
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	9
Current developments of the estimand concept	9

Incorporating historical information to improve dose optimization design with toxicity and efficacy endpoints: iBOIN‐ET	8
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
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	7
A MCP‐Mod approach to designing and analyzing survival trials with potential non‐proportional hazards	7
From innovative thinking to pharmaceutical industry implementation: Some success stories	7
Estimation of a treatment policy estimand for time to event data using data collected post discontinuation of randomised treatment	7
Quantification of follow‐up time in oncology clinical trials with a time‐to‐event endpoint: Asking the right questions	7
Confidence Intervals for Validation of Analytical Procedures Under ICH Q2 ( R2 )	7
Simulation‐based sequential design	7
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components	7
A meta‐analytic framework to adjust for bias in external control studies	7
An illness–death multistate model to implement delta adjustment and reference‐based imputation with time‐to‐event endpoints	6
Reflecting on Andy Grieve's influence and innovation: A personal perspective	6
Simultaneous Inference Using Multiple Marginal Models	6
Issue Information	6
	6
A Unified Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	6
Issue Information	6
Applying the Principal Stratum Strategy in Equivalence Trials: A Case Study	6
Finding the Optimal Number of Splits and Repetitions in Double Cross‐Fitting Targeted Maximum Likelihood Estimators	6
An evolutionary algorithm for the direct optimization of covariate balance between nonrandomized populations	5
Statistical methods for handling missing data to align with treatment policy strategy	5
	5
Interim decision making in seamless trial designs: An application in an adaptive dose‐finding study in a rare kidney disease	5
Simulation‐Based Bayesian Predictive Probability of Success for Interim Monitoring of Clinical Trials With Competing Event Data: Two Case Studies	5
Estimation of Treatment Policy Estimands for Continuous Outcomes Using Off‐Treatment Sequential Multiple Imputation	5
Chauhan Weighted Trajectory Analysis of Combined Efficacy and Safety Outcomes for Risk–Benefit Analysis	5
Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment	5
Should responder analyses be conducted on continuous outcomes?	5
BOIN ‐ MEM : A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Onco	5
Balance diagnostics in propensity score analysis following multiple imputation: A new method	4
The Wilcoxon–Mann–Whitney Estimand Versus Differences in Medians or Means	4
Propensity score matching and stratification using multiparty data without pooling	4
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	4
A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian Process Regression	4
Geometric approaches to assessing the numerical feasibility for conducting matching‐adjusted indirect comparisons	4
Bayesian borrowing from historical control data in a vaccine efficacy trial	4
Study‐design in pandemics: From surveillance and performance‐evaluation to licensing and pharmacovigilance	4
CUSUMIN Combination: A Cumulative Sum Interval Design for Phase I Cancer Drug‐Combination Trials	4
Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data	4
Evaluating hybrid controls methodology in early‐phase oncology trials: A simulation study based on the MORPHEUS‐UC trial	4
Issue Information	4
A Bayesian Hybrid Design With Borrowing From Historical Study	4
Frequentist and Bayesian tolerance intervals for setting specification limits for left‐censored gamma distributed drug quality attributes	4
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space	4
Beyond the Fragility Index	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
Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks	3

Issue Information	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
	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
An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial	3
Time‐to‐event estimands and loss to follow‐up in oncology in light of the estimands guidance	3
An adaptive biomarker basket design in phase II oncology trials	3
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	3
Bayesian optimal phase II designs with dual‐criterion decision making	3
	3
Issue Information	3
Improving the assessment of the probability of success in late stage drug development	3
Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide	3
Issue Information	3
Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study	3
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials	3
Type‐I‐error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications	3
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	3
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials	3
The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact	3
	3
Using Propensity Score Weighting to Enhance the Operating Characteristics of Power Prior in Leveraging External Data to Augment a Traditional Clinical Study	3