OOIR: Observatory of International Research

Papers

(The TQCC of Therapeutic Innovation & Regulatory Science is 4. 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 2021-11-01 to 2025-11-01.)

Article	Citations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	62
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	54
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	42
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	40
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	38
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	35
Anti-lung Cancer Marine Compounds: A Review	34
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	33
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	32
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	30
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	29
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial	28
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	26
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	26
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	24
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	22
A Generalization of the Two Trials Paradigm	22
Pharmacometrics: The Already-Present Future of Precision Pharmacology	22
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	22
Correction: Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	20
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	19
New Estimates on the Cost of a Delay Day in Drug Development	18
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	18
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	17
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	17

Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	17
Decentralized Clinical Trials in the Development of Drugs and Biological Products	16
Real World Evidence in Medical Cannabis Research	16
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	16
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	16
Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example	16
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	16
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	15
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	15
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	15
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	14
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	14
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	14
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	13
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	13
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	13
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	12
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	12
Japanese Regulatory Considerations for Interoperability of Medical Devices	12
Overdosage Section in US and EU Labeling	12
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	12
Performance Evaluation of Interim Analysis in Bioequivalence Studies	11
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	11
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	11
Training New DMC Members: A Call to Action	11
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	11
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	11
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	10
Digital Tools—Regulatory Considerations for Application in Clinical Trials	10
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)	10
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	9
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	9
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	9
Transforming Objective Participatory Patient Advocacy	9
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	9
Risk Management in Drug-Device Combination Product Development	9
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	9
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	9
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	8
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	8
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	8
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	8
AI/ML in Precision Medicine: A Look Beyond the Hype	8
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen	8
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Gen	8
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	8
Risk-Based Quality Management: A Case for Centralized Monitoring	8
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	8
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan	8
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8

Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	8
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support	7
Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science	7
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	7
Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development	7
Improving Informed Consent for English and Spanish Speakers in Clinical Trials	7
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application	7
Cancer Clinical Trial Patients’ Perceptions of Reporting Adverse Events Via an Electronic Platform	7
Statistical Analysis for Rating Scale in Clinical Trials	7
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	7
Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making	7
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	7
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	7
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	7
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	7
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	6
Bayesian Clinical Trials	6
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	6
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	6
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review	6
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	6
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	6
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	6
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools	6
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	6
Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease	6
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	6
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	6
Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan	6
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	6
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan	6
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	6
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	5
Application of Meta-analysis to Evaluate Relationships Among ARIA-E Rate, Amyloid Reduction Rate, and Clinical Cognitive Response in Amyloid Therapeutic Clinical Trials for Early Alzheimer’s Disease	5
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	5
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	5
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	5
Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020	5
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	5
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	5
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends	5
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward	4
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format	4
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	4
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance	4
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	4
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence	4
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	4
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	4
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	4
Digital Health Technologies in Pediatric Trials	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4