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

Article	Citations
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	52
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	45
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	43
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	43
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers	42
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial	38
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	36
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	34
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	33
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	30
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	28
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	28
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals	26
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	25
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines	24
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	24
Pharmacometrics: The Already-Present Future of Precision Pharmacology	23
A Generalization of the Two Trials Paradigm	23
Decentralized Clinical Trials in the Development of Drugs and Biological Products	22
Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example	21
Correction: Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	19
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	19
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	18
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	18

Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change	17
New Estimates on the Cost of a Delay Day in Drug Development	17
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	16
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	16
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	16
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	15
Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences	15
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	14
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	14
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	14
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	14
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	14
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	13
Clinicians’ Reactions to Point-of-Care Advertising in Electronic Health Records	13
Advancing Biomarker Qualification: FDA Perspective on Efficiency, Surrogate Endpoints, and Future Directions	13
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	13
Letter to the Editor: Battle Won but War Lost for Barth Syndrome Patients	13
“Measurement or Judgment?” Reconsidering Data Quality and Inference in EudraVigilance	13
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	12
Overdosage Section in US and EU Labeling	12
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	10
Performance Evaluation of Interim Analysis in Bioequivalence Studies	10
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	10
Risk Management in Drug-Device Combination Product Development	10
Transforming Objective Participatory Patient Advocacy	10
Training New DMC Members: A Call to Action	10
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	10
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	10
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	10
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)	10
Japanese Regulatory Considerations for Interoperability of Medical Devices	10
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	10
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	9
Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective	9
Digital Tools—Regulatory Considerations for Application in Clinical Trials	9
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	9
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	9
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	8
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	8
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	8
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	8
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support	8
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen	8
AI/ML in Precision Medicine: A Look Beyond the Hype	8
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	8
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	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
Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System	7
Cancer Clinical Trial Patients’ Perceptions of Reporting Adverse Events Via an Electronic Platform	7

Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making	7
Risk-Based Quality Management: A Case for Centralized Monitoring	7
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	7
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	7
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	7
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	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
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	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
Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland	7
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	7
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	7
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	7
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	7
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	7
Statistical Analysis for Rating Scale in Clinical Trials	7
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	6
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan	6
Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania	6
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	6
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools	6
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	6
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	6
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	6
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	6
Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science	6
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review	5
Beyond the Data: Addressing Ethical Concerns in Clinical Trials	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	5
Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies	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
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	5
Correction: Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges	5
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	5
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	5
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	5
Drug Repurposing in Oncology: A Strategic Pathway to Unlocking New Therapeutic Potential	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
Bayesian Clinical Trials	5
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	5
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	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
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
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
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	4
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	4
The Utilization of Externally Sourced Data and Data Collected and Analyzed from Previously Completed Studies Using Modelling and Simulation and Other Methodologies to Support Pediatric-Focused Regulat	4
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	4
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	4
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format	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
Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences	4
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials	4
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials	4
Comparative Assessment of the Pharmaceutical Quality of Amoxicillin Capsules Marketed in Authorized and an Unregulated Point of Sale in Mexican Market	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4
Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data	4
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	4
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	4
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data	4
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	4
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	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
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET®	4
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends	4
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	4
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023	4