Statistics in Biopharmaceutical Research

Papers
(The TQCC of Statistics in Biopharmaceutical Research 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 2020-05-01 to 2024-05-01.)
ArticleCitations
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic63
The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations41
Machine learning for clinical trials in the era of COVID-1939
Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-1937
Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group31
The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis31
Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?27
Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment24
Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials—Application of the Estimand Framework22
Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials22
The Hazards of Period Specific and Weighted Hazard Ratios19
The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis18
Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion14
Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event12
Statistical Models for Composite Endpoints of Death and Nonfatal Events: A Review12
Reference-Based Multiple Imputation—What is the Right Variance and How to Estimate It11
Developing a Targeted Learning-Based Statistical Analysis Plan11
Rejoinder to Letter to the Editor “The Hazards of Period Specific and Weighted Hazard Ratios”10
Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model9
Targeted Learning: Toward a Future Informed by Real-World Evidence9
Deep Learning Based Multimodal Progression Modeling for Alzheimer’s Disease9
Using Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect8
Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development8
Efficiency Comparison of Analysis Methods for Recurrent Event and Time-to-First Event Endpoints in the Presence of Terminal Events—Application to Clinical Trials in Chronic Heart Failure8
Properties of Two While-Alive Estimands for Recurrent Events and Their Potential Estimators8
Estimands and their Estimators for Clinical Trials Impacted by the COVID-19 Pandemic: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions8
Hypothetical Estimands in Clinical Trials: A Unification of Causal Inference and Missing Data Methods7
Under a Black Cloud Glimpsing a Silver Lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic7
Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion7
An Alternative Implementation of Reference-Based Controlled Imputation Procedures7
A Generalized Framework of Optimal Two-Stage Designs for Exploratory Basket Trials6
The Strong Null Hypothesis and the MaxCombo Test: Comment on “Robust Design and Analysis of Clinical Trials with Nonproportional Hazards: A Straw Man Guidance form a Cross-Pharma Working Group.”6
Bayesian Optimal Phase II Design for Randomized Clinical Trials6
Nonproportional Hazards—An Evaluation of the MaxCombo Test in Cancer Clinical Trials6
Bayesian Hierarchical Modeling and Biomarker Cutoff Identification in Basket Trials6
Statistical Observations on Vaccine Clinical Development for Pandemic Diseases6
Editorial: Roles of Hypothesis Testing, p-Values and Decision Making in Biopharmaceutical Research6
Incorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Re-Estimation6
Statistical Considerations for Sequential Analysis of the Restricted Mean Survival Time for Randomized Clinical Trials6
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience6
A Phase 3 Trial Analysis Proposal for Mitigating the Impact of the COVID-19 Pandemic6
Missing Data Imputation With Baseline Information in Longitudinal Clinical Trials6
Optimizing Graphical Procedures for Multiplicity Control in a Confirmatory Clinical Trial via Deep Learning6
Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”5
Weighted Approach for Estimating Effects in Principal Strata With Missing Data for a Categorical Post-Baseline Variable in Randomized Controlled Trials5
Partial Correlation Coefficient for a Study With Repeated Measurements5
Good Data Science Practice: Moving Toward a Code of Practice for Drug Development5
Predicting the COVID-19 Pandemic Impact on Clinical Trial Recruitment5
Improvement in the Analysis of Vaccine Adverse Event Reporting System Database5
Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics5
Radical Thinking: Scientific Rigor and Pragmatism4
Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes4
Application of Group Sequential Methods to the 2-in-1 Design and Its Extensions for Interim Monitoring4
OPTIM-ARTS—An Adaptive Phase II Open Platform Trial Design With Application to a Metastatic Melanoma Study4
Quantifying Replicability and Consistency in Systematic Reviews4
Comment on “Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic”4
Sample Size Calculation for “Gold-Standard” Noninferiority Trials With Fixed Margins and Negative Binomial Endpoints4
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions4
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow4
Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-194
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic4
Bayesian Change-Point Joint Models for Multivariate Longitudinal and Time-to-Event Data3
A Simulation Study on the Estimation of the Effect in the Hypothetical Scenario of No Use of Symptomatic Treatment in Trials for Disease-Modifying Agents for Alzheimer’s Disease3
Quick Multiple Test Procedures and p-Value Adjustments3
Systematic Review of Published Meta-Analyses of Vaccine Safety3
Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”3
An Improved Sample Size Calculation Method for Score Tests in Generalized Linear Models3
Testing and Interpreting the “Right” Hypothesis—Comment on “Non-proportional Hazards — An Evaluation of the MaxCombo Test in Cancer Clinical Trials”3
Generalizing Clinical Trial Results to a Target Population3
Applying Quantitative Approaches in the Use of RWE in Clinical Development and Life-Cycle Management3
Predictive Biomarker Identification for Biopharmaceutical Development3
Post-Test Diagnostic Accuracy Measures of a Continuous Test With a Disease of Ordinal Multistages3
Bootstrap Cross-validation Improves Model Selection in Pharmacometrics3
Sample Size Allocation in Multiregional Dose-Finding Study Using MCP-Mod3
Our Most Important Discovery: The Question3
A Comparison of Different Approaches to Bayesian Hierarchical Models in a Basket Trial to Evaluate the Benefits of Increasing Complexity3
Simulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis3
Bayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes3
Selecting an Optimal Design for a Non-randomized Comparative Study: A Comment on “Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Utilizing Propensity Score Method3
Assessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints3
It’s the Selection’s Fault—Not the p-Values’: A Comment on “The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations”3
On Identification of the Principal Stratum Effect in Patients Who Would Comply If Treated3
Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches3
Estimands in Real-World Evidence Studies3
Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation3
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