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 2021-05-01 to 2025-05-01.)

Article	Citations
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies	82
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	53
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	48
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	39
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	32
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	30
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	30
Anti-lung Cancer Marine Compounds: A Review	30
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	28
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	26
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	25
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	23
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	23
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development	23
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	22
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	22
Decentralized Clinical Trials in the Development of Drugs and Biological Products	20
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	20
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	19
Real World Evidence in Medical Cannabis Research	18
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	18
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	17
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	17
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	16
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	16

Pharmacometrics: The Already-Present Future of Precision Pharmacology	16
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	15
A Generalization of the Two Trials Paradigm	15
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	14
New Estimates on the Cost of a Delay Day in Drug Development	14
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	14
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	14
Open Source Analytics App for Clinical Trials: Letter to the Editor—A Novel App for Insights into Laboratory Data of Clinical Trials	13
The Competency of Clinical Research Coordinators: The Importance of Education and Experience	13
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	12
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	12
Government Pharmaceutical Development to Address High Prices: Challenges Ahead	12
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	11
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	11
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans	11
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	11
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	11
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	11
Risk Management in Drug-Device Combination Product Development	10
Training New DMC Members: A Call to Action	10
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	10
Japanese Regulatory Considerations for Interoperability of Medical Devices	10
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	10
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	10
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	10
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	10
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	10
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	10
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	9
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	9
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	9
Overdosage Section in US and EU Labeling	9
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	9
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	9
Digital Tools—Regulatory Considerations for Application in Clinical Trials	9
Performance Evaluation of Interim Analysis in Bioequivalence Studies	9
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	8
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	8
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	8
AI/ML in Precision Medicine: A Look Beyond the Hype	8
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	8
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	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
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	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
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	7
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	7
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	7
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan	7

Statistical Analysis for Rating Scale in Clinical Trials	7
Risk-Based Quality Management: A Case for Centralized Monitoring	7
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	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
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	7
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	6
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	6
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	6
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	6
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	6
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	6
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	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
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	6
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	6
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan	6
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	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
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	6
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
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises	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
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	5
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	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
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	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
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Bayesian Clinical Trials	5
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates	5
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	5
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	5
Cutting Through the “Gray Area”: An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research	5
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	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
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions	4
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	4
Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation	4
Treatment of Death Events in the Analysis of Time to Progression	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	4
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	4
Correction to: Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates	4
Digital Health Technologies in Pediatric Trials	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
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
The Predictive Individual Effect for Survival 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 Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	4
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations	4
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	4
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa	4
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm 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
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	4
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	4