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

Article	Citations
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	46
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	45
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	39
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	38
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	37
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	36
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	35
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	31
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	29
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	29
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	29
Anti-lung Cancer Marine Compounds: A Review	27
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	26
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial	25
Pharmacometrics: The Already-Present Future of Precision Pharmacology	23
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	23
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	22
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	21
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
Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example	18
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	18
Decentralized Clinical Trials in the Development of Drugs and Biological Products	18
A Generalization of the Two Trials Paradigm	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
New Estimates on the Cost of a Delay Day in Drug Development	17
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	16
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	16
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	16
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	16
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	16
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	15
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	15
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	15
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	14
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	14
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	14
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	14
Overdosage Section in US and EU Labeling	13
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	13
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	13
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	13
Training New DMC Members: A Call to Action	13
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	13
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	13
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	12
Japanese Regulatory Considerations for Interoperability of Medical Devices	12
Digital Tools—Regulatory Considerations for Application in Clinical Trials	12
Risk Management in Drug-Device Combination Product Development	12
Transforming Objective Participatory Patient Advocacy	11
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	11
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	11
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)	10
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	10
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	10
Performance Evaluation of Interim Analysis in Bioequivalence Studies	10
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	10
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	9
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	9
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	9
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	9
Risk-Based Quality Management: A Case for Centralized Monitoring	9
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	9
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	9
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	9
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	9
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	9
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	9
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	9
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan	9
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support	9
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	8
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen	8
Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science	8

A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	8
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8
Cancer Clinical Trial Patients’ Perceptions of Reporting Adverse Events Via an Electronic Platform	8
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	8
AI/ML in Precision Medicine: A Look Beyond the Hype	8
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	7
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	7
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	7
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	7
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	7
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
Statistical Analysis for Rating Scale in Clinical Trials	7
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	7
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	7
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	7
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	7
Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development	7
Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making	7
Improving Informed Consent for English and Spanish Speakers in Clinical Trials	7
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	7
Bayesian Clinical Trials	7
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	7
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
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	6
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	6
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	6
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	6
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	6
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	6
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	6
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	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
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan	6
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	6
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	6
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review	6
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	6
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	6
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
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	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
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	5
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	5
Drug Repurposing in Oncology: A Strategic Pathway to Unlocking New Therapeutic Potential	5
Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET®	5
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials	5
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies	5
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	5
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends	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
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
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials	4
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023	4
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	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
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
Digital Health Technologies in Pediatric Trials	4
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	4
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results	4
Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development	4
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa	4
Correction: The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	4
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials	4
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
The Predictive Individual Effect for Survival Data	4
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapie	4
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials	4
Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences	4
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	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
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format	4