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

Article	Citations
Frailty model with change points for survival analysis	52
Generalizing Treatment Effect to a Target Population Without Individual Patient Data in a Real‐World Setting	33
Prediction Intervals for Overdispersed Binomial Endpoints and Their Application to Toxicological Historical Control Data	32
A Likelihood Perspective on Dose‐Finding Study Designs in Oncology	25
Average Hazard as Harmonic Mean	21
Improved inference forMCP‐Modapproach using time‐to‐event endpoints with small sample sizes	20
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	18
Pre‐Posterior Distributions in Drug Development and Their Properties	17
Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy	16
Adaptive Constrained Weighted Estimation for Incorporating Multiple External Information Sources	15
Prospectively Specified Adaptive Bayesian Borrowing: Considerations, Methodologies, and Implementations	14
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	14
Using Off‐Treatment Sequential Multiple Imputation for Binary Outcomes to Address Intercurrent Events Handled by a Treatment Policy Strategy	13
A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials	13
Issue Information	12
	12
CUSUMIN: A cumulative sum interval design for cancer phase I dose finding studies	12
Incorporating historical information to improve dose optimization design with toxicity and efficacy endpoints: iBOIN‐ET	10
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery	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
Improving early phase oncology clinical trial design: The case for finding the optimal biological dose	10
Information‐based group sequential design for post‐market safety monitoring of medical products using real world data	10
Why “Minimal Clinically Important Difference” for Interpreting the Magnitude of the Treatment Effect Is Not Useful	10

A meta‐analytic framework to adjust for bias in external control studies	9
Extending Multiple Testing With Unknown Test Dependency via the CoCo Test: With Applications to Cancer Studies	9
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	9
Applying the Estimand Framework to Non‐Inferiority Trials	8
Multiplicity Adjustment Methods for a Three‐Way Crossover Bioequivalence Study	8
A MCP‐Mod approach to designing and analyzing survival trials with potential non‐proportional hazards	7
Current developments of the estimand concept	7
Simulation‐based sequential design	7
From innovative thinking to pharmaceutical industry implementation: Some success stories	7
Confidence Intervals for Validation of Analytical Procedures Under ICH Q2 ( R2 )	7
Quantification of follow‐up time in oncology clinical trials with a time‐to‐event endpoint: Asking the right questions	7
A conservative approach to leveraging external evidence for effective clinical trial design	7
Finding the Optimal Number of Splits and Repetitions in Double Cross‐Fitting Targeted Maximum Likelihood Estimators	7
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components	6
Issue Information	6
BOIN ‐ MEM : A Two‐Stage Design for Dose Optimization With Information Borrowing Across Dose Levels and Stages in Onco	6
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	6
An illness–death multistate model to implement delta adjustment and reference‐based imputation with time‐to‐event endpoints	6
A Unified Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials	6
Simultaneous Inference Using Multiple Marginal Models	6
Statistical methods for handling missing data to align with treatment policy strategy	5
Reflecting on Andy Grieve's influence and innovation: A personal perspective	5
	5
Balance diagnostics in propensity score analysis following multiple imputation: A new method	5
Interim decision making in seamless trial designs: An application in an adaptive dose‐finding study in a rare kidney disease	5
Should responder analyses be conducted on continuous outcomes?	5
Application of Causal Inference to Establish Assay Effect in the Absence of a Bridging Study: A Case Study of MenACWY ‐ CRM<	5
Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment	5
An evolutionary algorithm for the direct optimization of covariate balance between nonrandomized populations	5
Frequentist and Bayesian tolerance intervals for setting specification limits for left‐censored gamma distributed drug quality attributes	5
	5
Applying the Principal Stratum Strategy in Equivalence Trials: A Case Study	5
Chauhan Weighted Trajectory Analysis of Combined Efficacy and Safety Outcomes for Risk–Benefit Analysis	5
Simulation‐Based Bayesian Predictive Probability of Success for Interim Monitoring of Clinical Trials With Competing Event Data: Two Case Studies	5
Bayesian borrowing from historical control data in a vaccine efficacy trial	5
Informing the Borrowing Process for Dose‐Finding Trials by Estimating the Similarity Between Population‐Specific Dose‐Toxicity Curves	5
Issue Information	4
A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian Process Regression	4
	4
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	4
CUSUMIN Combination: A Cumulative Sum Interval Design for Phase I Cancer Drug‐Combination Trials	4
A Tree‐Based Scan Statistic for Detecting Signals of Drug–Drug Interactions in Spontaneous Reporting Databases	4
The Wilcoxon–Mann–Whitney Estimand Versus Differences in Medians or Means	4
Evaluating hybrid controls methodology in early‐phase oncology trials: A simulation study based on the MORPHEUS‐UC trial	4
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	4
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials	4
The Acute Stroke Therapy by Inhibition of Neutrophils study – Key features and impact	4
A Bayesian Hybrid Design With Borrowing From Historical Study	4
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space	4
Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data	4

A Tobit Partly Linear Mixed and Mixture Cure Model for the Joint Analysis of Interval‐Bounded Longitudinal Measurements and Survival Times With Cure Proportion	4
Propensity score matching and stratification using multiparty data without pooling	4
Designing and Evaluating Bayesian Advanced Adaptive Randomised Clinical Trials: A Practical Guide	4
Improving precision and power in randomized trials with a two‐stage study design: Stratification using clustering method	4
Issue Information	4
Beyond the Fragility Index	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
Multiple Comparisons With Overdispersed Multinomial Data: Methods, Properties and Application	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
On the use of extreme value tail modeling for generalized pairwise comparisons with censored outcomes	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
An adaptive biomarker basket design in phase II oncology trials	3
Time‐to‐event estimands and loss to follow‐up in oncology in light of the estimands guidance	3
Quality by Design for Preclinical In Vitro Assay Development	3
Issue Information	3
Web based resource for Statistical Consultants in the Pharmaceutical Industry	3
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials	3
Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks	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
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	3
	3
Bayesian optimal phase II designs with dual‐criterion decision making	3
Comparing various Bayesian random‐effects models for pooling randomized controlled trials with rare events	3
Issue Information	3
Dynamic borrowing of historical controls adjusting for covariates in vaccine efficacy clinical trials	3
Type‐I‐error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications	3
	3