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 2021-08-01 to 2025-08-01.)

Article	Citations
Frailty model with change points for survival analysis	33
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	22
A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials	18
Improved inference forMCP‐Modapproach using time‐to‐event endpoints with small sample sizes	18
Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy	17
Pre‐Posterior Distributions in Drug Development and Their Properties	16
Generalizing Treatment Effect to a Target Population Without Individual Patient Data in a Real‐World Setting	16
A Likelihood Perspective on Dose‐Finding Study Designs in Oncology	15
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	13
Average Hazard as Harmonic Mean	13
A conservative approach to leveraging external evidence for effective clinical trial design	13
	13
A meta‐analytic framework to adjust for bias in external control studies	13
Information‐based group sequential design for post‐market safety monitoring of medical products using real world data	12
Issue Information	12
To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines	11
A two‐stage drop‐the‐losers design for time‐to‐event outcome using a historical control arm	11
CUSUMIN: A cumulative sum interval design for cancer phase I dose finding studies	11
Current developments of the estimand concept	10
Improving early phase oncology clinical trial design: The case for finding the optimal biological dose	10
A Model‐Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology	10
Applying the Estimand Framework to Non‐Inferiority Trials	10
Confidence Intervals for the Risk Difference Between Secondary and Primary Infection Based on the Method of Variance Estimates Recovery	10
Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior	10
Control of Unconditional Type I Error in Clinical Trials With External Control Borrowing—A Two‐Stage Adaptive Design Perspective	9

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	8
Why “Minimal Clinically Important Difference” for Interpreting the Magnitude of the Treatment Effect Is Not Useful	8
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	7
Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components	7
Issue Information	7
Simulation‐based sequential design	7
Estimation of a treatment policy estimand for time to event data using data collected post discontinuation of randomised treatment	7
Simultaneous Inference Using Multiple Marginal Models	7
Quantification of follow‐up time in oncology clinical trials with a time‐to‐event endpoint: Asking the right questions	7
A MCP‐Mod approach to designing and analyzing survival trials with potential non‐proportional hazards	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
Interim decision making in seamless trial designs: An application in an adaptive dose‐finding study in a rare kidney disease	6
Should responder analyses be conducted on continuous outcomes?	6
An evolutionary algorithm for the direct optimization of covariate balance between nonrandomized populations	6
Statistical methods for handling missing data to align with treatment policy strategy	5
Statistical detection of synergy: New methods and a comparative study	5
Evaluating hybrid controls methodology in early‐phase oncology trials: A simulation study based on the MORPHEUS‐UC trial	5
Tutorial on Firth's Logistic Regression Models for Biomarkers in Preclinical Space	5
Applying the Principal Stratum Strategy in Equivalence Trials: A Case Study	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
Propensity score matching and stratification using multiparty data without pooling	5
Bayesian borrowing from historical control data in a vaccine efficacy trial	5
Bayesian Response Adaptive Randomization for Randomized Clinical Trials With Continuous Outcomes: The Role of Covariate Adjustment	5
	5
Estimation of Treatment Policy Estimands for Continuous Outcomes Using Off‐Treatment Sequential Multiple Imputation	5
Balance diagnostics in propensity score analysis following multiple imputation: A new method	5
Improving precision and power in randomized trials with a two‐stage study design: Stratification using clustering method	5
Chauhan Weighted Trajectory Analysis of Combined Efficacy and Safety Outcomes for Risk–Benefit Analysis	5
Using an interim analysis based exclusively on an early outcome in a randomized clinical trial with a long‐term clinical endpoint	5
Methodological challenges in the analysis of recurrent events for randomised controlled trials with application to cardiovascular events in LEADER	4
A Personalized Dose‐Finding Algorithm Based on Adaptive Gaussian Process Regression	4
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	4
	4
Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan	4
Beyond the Fragility Index	4
Issue Information	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
“Super‐covariates”: Using predicted control group outcome as a covariate in randomized clinical trials	4
Comparative Analyses of Bioequivalence Assessment Methods for In Vitro Permeation Test Data	4
Geometric approaches to assessing the numerical feasibility for conducting matching‐adjusted indirect comparisons	4
CUSUMIN Combination: A Cumulative Sum Interval Design for Phase I Cancer Drug‐Combination Trials	4
Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks	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
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
Semi‐parametric accelerated failure‐time model: A useful alternative to the proportional‐hazards model in cancer clinical trials	3

An adaptive biomarker basket design in phase II oncology trials	3
	3
Issue Information	3
Time‐to‐event estimands and loss to follow‐up in oncology in light of the estimands guidance	3
Group sequential design with maximin efficiency robust test for immunotherapy with generalized delayed treatment effect	3
	3
Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	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
Type‐I‐error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications	3
Issue Information	3
Bayesian optimal phase II designs with dual‐criterion decision making	3
Improving the assessment of the probability of success in late stage drug development	3
Dynamic borrowing of historical controls adjusting for covariates in vaccine efficacy clinical trials	3
Comparing various Bayesian random‐effects models for pooling randomized controlled trials with rare events	3
On the use of extreme value tail modeling for generalized pairwise comparisons with censored outcomes	3
Issue Information	3
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials	3
An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial	3
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	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