Pharmaceutical Statistics

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
Average Hazard as Harmonic Mean	13
A conservative approach to leveraging external evidence for effective clinical trial design	13
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A meta‐analytic framework to adjust for bias in external control studies	13
Weighted log‐rank test to compare two survival functions in the presence of dependent censoring	13
Issue Information	12
Information‐based group sequential design for post‐market safety monitoring of medical products using real world data	12
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
To Dilute or Not to Dilute: Nominal Titer Dosing for Genetic Medicines	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
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
Mixture Experimentation in Pharmaceutical Formulations: A Tutorial	7
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
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
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
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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
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
What they forgot to tell you about machine learning with an application to pharmaceutical manufacturing	4
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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
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
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
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
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Multiple Comparisons Procedures for Analyses of Joint Primary Endpoints and Secondary Endpoints	3
Issue Information	3
Bayesian optimal phase II designs with dual‐criterion decision making	3
Effects of duration of follow‐up and lag in data collection on the performance of adaptive clinical trials	3
Improving the assessment of the probability of success in late stage drug development	3
An adaptive design for early clinical development including interim decision for single‐arm trial with external controls or randomized trial	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
Semi‐parametric accelerated failure‐time model: A useful alternative to the proportional‐hazards model in cancer clinical trials	3
Futility Interim Analysis Based on Probability of Success Using a Surrogate Endpoint	3
An adaptive biomarker basket design in phase II oncology trials	3
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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
Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks	3
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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
A Tipping Point Method to Evaluate Sensitivity to Potential Violations in Missing Data Assumptions	2
Just say no to data listings!	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
Sample Size Estimation Using a Partially Clustered Frailty Model for Biomarker‐Strategy Designs With Multiple Treatments	2
Estimation of multivariate treatment effects in contaminated clinical trials	2
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Quality by Design for Preclinical In Vitro Assay Development	2
On the relative conservativeness of Bayesian logistic regression method in oncology dose‐finding studies	2
Potential Bias Models With Bayesian Shrinkage Priors for Dynamic Borrowing of Multiple Historical Control Data	2
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Robust estimates of regional treatment effects in multiregional randomized clinical trials with semiparametric logistic model	2
Transporting randomized trial results to estimate counterfactual survival functions in target populations	2
Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach	2
Statistical analysis of actigraphy data with generalised additive models	2
A Commensurate Prior Model With Random Effects for Survival and Competing Risk Outcomes to Accommodate Historical Controls	2
Alone, together: On the benefits of Bayesian borrowing in a meta‐analytic setting	2
Confidence intervals for point‐of‐stabilization of content uniformity	2
A note on point estimation and interval estimation of the relative treatment effect under a simple crossover design	2
Confidence intervals for exposure‐adjusted rate differences in randomized trials	2
Adaptively leveraging external data with robust meta‐analytical‐predictive prior using empirical Bayes	2
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Comments on “Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study”	2
Variable Duration Trial as an Alternative Design for Continuous Endpoints	2
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Introduction to Nonclinical Biopharmaceutical Statistics Tutorials—A Special Issue	2
Investigating Stability in Subgroup Identification for Stratified Medicine	2
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Should the two‐trial paradigm still be the gold standard in drug assessment?	2
Predictive Ppk calculations for biologics and vaccines using a Bayesian approach – a tutorial	2
Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials	2
Application of hypothetical strategies in acute pain	2
Rejoinder to the letter: “Standard and reference‐based conditional mean imputation: Regulators and trial statisticians be aware!”	2
Principles for Defining Estimands in Clinical Trials—A Proposal	2
Web based resource for Statistical Consultants in the Pharmaceutical Industry	2
Issue Information	2
PubPredict: Prediction of progression and survival in oncology leveraging publications and early efficacy data	2
Visualizing hypothesis tests in survival analysis under anticipated delayed effects	2
Sample Size Estimation for Correlated Count Data With Changes in Dispersion	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
Return‐to‐baseline multiple imputation for missing values in clinical trials	1
How to avoid concerns with the interpretation of two primary endpoints if significant superiority in one is sufficient for formal proof of efficacy	1
Probability of success and group sequential designs	1
Natural cubic splines for the analysis of Alzheimer's clinical trials	1
Heterogeneity in treatment effects across diverse populations	1
The utilities and pitfalls of stratified analysis in challenging situations	1
A Federated Data Analysis Approach for the Evaluation of Surrogate Endpoints	1
Sample size re‐estimation in Phase 2 dose‐finding: Conditional power versus Bayesian predictive power	1
Adjusting for bias in the mean for primary and secondary outcomes when trials are in sequence	1
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Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development	1
Statistical modeling approaches for the comparison of dissolution profiles	1
Empirical likelihood inference for area under the receiver operating characteristic curve using ranked set samples	1
Statistical considerations for design and analysis of stability, comparability and formulation tests	1
Sample size calculation for comparing two ROC curves	1
Information fraction estimation: Strategies for a phase 3 non‐inferiority maximum duration design with time to event outcome	1
Estimating survival parameters under conditionally independent left truncation	1
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Comparison of nonparametric estimators of the expected number of recurrent events	1
Ensuring exchangeability indata‐basedpriors for a Bayesian analysis of clinical trials	1

Introduction to qualification and validation of an immunoassay	1
A Phase I Dose‐Finding Design Incorporating Intra‐Patient Dose Escalation	1
A treatment‐specific marginal structural Cox model for the effect of treatment discontinuation	1
Assessment of pharmacokinetic linearity after repeated drug administration	1
A comparison of statistical methods for animal oncology studies	1
Getting (More Out of) Graphics—Practices and Principles of Data Visualisation. Data Science SeriesBy AntonyUnwin, Chapman & Hall/CRC, 2024. 446 pp. $ 74.99. ISBN: 978‐0‐36‐767399‐4	1
Real Effect or Bias? Good Practices for Evaluating the Robustness of Evidence From Comparative Observational Studies Through Quantitative Sensitivity Analysis for Unmeasured Confounding	1
A simulation‐based comparison of estimation methods for adaptive and classical group sequential clinical trials	1
Using the Bayesian detection of potential risk using inference on blinded safety data (BDRIBS) method to support the decision to refer an event for unblinded evaluation	1
Do statisticians count? A prior and posterior viewpoint	1
Evaluation of a flexible piecewise linear mixed‐effects model in the analysis of randomized cross‐over trials	1
Issue Information	1
Do You Want to Stay Single? Considerations on Single‐Arm Trials in Drug Development and the Postregulatory Space	1
Survival Analysis Without Sharing of Individual Patient Data by Using a Gaussian Copula	1
Reparametrized Firth's Logistic Regressions for Dose‐Finding Study With the Biased‐Coin Design	1
Issue Information	1
Digital twins and Bayesian dynamic borrowing: Two recent approaches for incorporating historical control data	1
An improved score‐type confidence interval for stratified risk differences involving rare events	1
Subgroup Identification Based on Quantitative Objectives	1
A practical guide to sample size calculations: Installation of the app SampSize	1
Flexible parametric copula modeling approaches for clustered survival data	1
Confirmatory efficacy testing for individual dose–placebo comparisons using serial gatekeeping procedure in dose‐finding trials with multiple comparison procedures–modeling	1
Taylor Series Approximation for Accurate Generalized Confidence Intervals of Ratios of Log‐Normal Standard Deviations for Meta‐Analysis Using Means and Standard Deviations in Time Scale	1
Standard and reference‐based conditional mean imputation	1
Issue Information	1
Issue Information	1
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A Flexible Seamless Phase 2/3 Design With Biomarker‐Driven Subgroup Enrichment and Sample Size Re‐Estimation	1
Personalized Treatment Selection for Multivariate Ordinal Scale Outcomes and Multiple Treatments	1
Estimating the treatment effect for adherers using multiple imputation	1
A Tutorial on Improving RCT Power Using Prognostic Score Adjustment for Linear Models	1
Estimands for overall survival in clinical trials with treatment switching in oncology	1
The design and analysis of vaccine trials for COVID‐19 for the purpose of estimating efficacy	1
Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation	1
AIDE: Adaptive intrapatient dose escalation designs to accelerate Phase I clinical trials	1
A Bayesian optimal interval design for dose optimization with a randomization scheme based on pharmacokinetics outcomes in oncology	1
Optimal unplanned design modification in adaptive two‐stage trials	1
Issue Information	1
Replenishing the pipeline: A quantitative approach to optimising the sourcing of new projects	1
Issue Information	1
Simulating and reporting frequentist operating characteristics of clinical trials that borrow external information: Towards a fair comparison in case of one‐arm and hybrid control two‐arm trials	1
Decision rules for identifying combination therapies in open‐entry, randomized controlled platform trials	1
Setting the control limit at release for stability assurance	1
Time‐to‐event calibration‐free odds design: A robust efficient design for phase I trials with late‐onset outcomes	1
Correction to “Mixture Experimentation in Pharmaceutical Formulations: A Tutorial”	1
A propensity score‐integrated approach for leveraging external data in a randomized controlled trial with time‐to‐event endpoints	1
Vaccine clinical trials with dynamic borrowing of historical controls: Two retrospective studies	1
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors	1
Detection of Outlying Correlation Coefficients in Multicenter Clinical Trials	1
PKBOIN‐12: A Bayesian Optimal Interval Phase I/II Design Incorporating Pharmacokinetics Outcomes to Find the Optimal Biological Dose	1
A model‐assisted design for partially or completely ordered groups	1
Issue Information	1
A Bayesian Dynamic Model‐Based Adaptive Design for Oncology Dose Optimization in Phase I/II Clinical Trials	1
Issue Information	1