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

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	26
Prediction Intervals for Overdispersed Binomial Endpoints and Their Application to Toxicological Historical Control Data	23
Pre‐Posterior Distributions in Drug Development and Their Properties	21
A Likelihood Perspective on Dose‐Finding Study Designs in Oncology	19
Average Hazard as Harmonic Mean	18
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	17
Adaptive Constrained Weighted Estimation for Incorporating Multiple External Information Sources	16
A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials	15
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	15
Prospectively Specified Adaptive Bayesian Borrowing: Considerations, Methodologies, and Implementations	15
Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy	14
	13
Improved inference forMCP‐Modapproach using time‐to‐event endpoints with small sample sizes	13
Issue Information	12
CUSUMIN: A cumulative sum interval design for cancer phase I dose finding studies	11
Improving early phase oncology clinical trial design: The case for finding the optimal biological dose	10
Why “Minimal Clinically Important Difference” for Interpreting the Magnitude of the Treatment Effect Is Not Useful	10
Control of Unconditional Type I Error in Clinical Trials With External Control Borrowing—A Two‐Stage Adaptive Design Perspective	10
A Model‐Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology	10
To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines	10
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery	9
Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior	9
A conservative approach to leveraging external evidence for effective clinical trial design	9
Current developments of the estimand concept	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	7
Applying the Estimand Framework to Non‐Inferiority Trials	7
A MCP‐Mod approach to designing and analyzing survival trials with potential non‐proportional hazards	7
Extending Multiple Testing With Unknown Test Dependency via the CoCo Test: With Applications to Cancer Studies	7
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	7
From innovative thinking to pharmaceutical industry implementation: Some success stories	7
Confidence Intervals for Validation of Analytical Procedures Under ICH Q2 ( R2 )	7
A meta‐analytic framework to adjust for bias in external control studies	7
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components	6
Issue Information	6
Simultaneous Inference Using Multiple Marginal Models	6
Estimation of a treatment policy estimand for time to event data using data collected post discontinuation of randomised treatment	6
Simulation‐based sequential design	6
A Unified Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	6
Quantification of follow‐up time in oncology clinical trials with a time‐to‐event endpoint: Asking the right questions	6
Finding the Optimal Number of Splits and Repetitions in Double Cross‐Fitting Targeted Maximum Likelihood Estimators	6
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	6
An evolutionary algorithm for the direct optimization of covariate balance between nonrandomized populations	5
Chauhan Weighted Trajectory Analysis of Combined Efficacy and Safety Outcomes for Risk–Benefit Analysis	5
Issue Information	5
	5
Interim decision making in seamless trial designs: An application in an adaptive dose‐finding study in a rare kidney disease	5
An illness–death multistate model to implement delta adjustment and reference‐based imputation with time‐to‐event endpoints	5
Applying the Principal Stratum Strategy in Equivalence Trials: A Case Study	5
Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment	5
Reflecting on Andy Grieve's influence and innovation: A personal perspective	5
Bayesian borrowing from historical control data in a vaccine efficacy trial	4
Should responder analyses be conducted on continuous outcomes?	4
	4
Frequentist and Bayesian tolerance intervals for setting specification limits for left‐censored gamma distributed drug quality attributes	4
A Tree‐Based Scan Statistic for Detecting Signals of Drug–Drug Interactions in Spontaneous Reporting Databases	4
Beyond the Fragility Index	4
BOIN ‐ MEM : A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Onco	4
Informing the Borrowing Process for Dose‐Finding Trials by Estimating the Similarity Between Population‐Specific Dose‐Toxicity Curves	4
Balance diagnostics in propensity score analysis following multiple imputation: A new method	4
Study‐design in pandemics: From surveillance and performance‐evaluation to licensing and pharmacovigilance	4
Estimation of Treatment Policy Estimands for Continuous Outcomes Using Off‐Treatment Sequential Multiple Imputation	4
A Bayesian Hybrid Design With Borrowing From Historical Study	4
Simulation‐Based Bayesian Predictive Probability of Success for Interim Monitoring of Clinical Trials With Competing Event Data: Two Case Studies	4
Statistical methods for handling missing data to align with treatment policy strategy	4
The Wilcoxon–Mann–Whitney Estimand Versus Differences in Medians or Means	4
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space	4
Propensity score matching and stratification using multiparty data without pooling	4
CUSUMIN Combination: A Cumulative Sum Interval Design for Phase I Cancer Drug‐Combination Trials	4
Issue Information	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
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	3
Issue Information	3

Issue Information	3
Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide	3
Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study	3
A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian Process Regression	3
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	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
Bayesian optimal phase II designs with dual‐criterion decision making	3
The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact	3
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials	3
Issue Information	3
Improving precision and power in randomized trials with a two‐stage study design: Stratification using clustering method	3
An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial	3
Using Propensity Score Weighting to Enhance the Operating Characteristics of Power Prior in Leveraging External Data to Augment a Traditional Clinical Study	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
Type‐I‐error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications	3
	3
Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan	3
Evaluating hybrid controls methodology in early‐phase oncology trials: A simulation study based on the MORPHEUS‐UC trial	3
Geometric approaches to assessing the numerical feasibility for conducting matching‐adjusted indirect comparisons	3
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	3
Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data	3