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 2020-11-01 to 2024-11-01.)

Article	Citations
The Use of External Controls in FDA Regulatory Decision Making	70
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design	44
Real World Evidence in Medical Cannabis Research	43
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials	33
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019	25
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulati	24
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	24
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	23
Assessing the Financial Value of Decentralized Clinical Trials	23
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments	18
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future	18
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements	18
Factors Affecting Success of New Drug Clinical Trials	18
Effective Data Sharing as a Conduit for Advancing Medical Product Development	17
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	17
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	16
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	16
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021	16
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	16
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum	15
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	15
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	14
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications	14
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities	14
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies	13

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative	12
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	12
Extrapolation as a Default Strategy in Pediatric Drug Development	12
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020	11
Innovation Pathways in the NHS: An Introductory Review	11
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	11
Risk-Based Monitoring in Clinical Trials: 2021 Update	11
A Tutorial on Modern Bayesian Methods in Clinical Trials	11
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic	11
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial	11
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle	11
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children	10
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion	10
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	9
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform	9
The Role of Master Protocols in Pediatric Drug Development	9
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER	9
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation	9
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	9
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity	9
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development	9
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity	9
Addressing Bias in Responder Analysis of Patient-Reported Outcomes	8
Trends and Characteristics of New Drug Approvals in China, 2011–2021	8
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	8
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials	8
Improving Development of Drug Treatments for Pregnant Women and the Fetus	8
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	8
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	7
Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS	7
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training	7
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	7
Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic	7
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach	7
Anti-lung Cancer Marine Compounds: A Review	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?	7
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey	7
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	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	7
Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide	7
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	7
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims	6
AI/ML in Precision Medicine: A Look Beyond the Hype	6
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines	6
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	6
Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines	6
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	6
Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance	6
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters	6

Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries	6
MedDRA Labeling Groupings to Improve Safety Communication in Product Labels	6
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring	6
The Competency of Clinical Research Coordinators: The Importance of Education and Experience	6
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further	6
Mixed Models for Repeated Measures Should Include Time-by-Covariate Interactions to Assure Power Gains and Robustness Against Dropout Bias Relative to Complete-Case ANCOVA	5
Digital Tools—Regulatory Considerations for Application in Clinical Trials	5
Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects	5
Bayesian Statistics for Medical Devices: Progress Since 2010	5
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration	5
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	5
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing	5
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA	5
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities	5
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	5
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	5
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	5
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	5
Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide	5
Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy	5
U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newl	5
Protocol Deviations: A Holistic Approach from Defining to Reporting	5
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey	5
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan	5
Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000–2018)	4
Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials	4
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe	4
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	4
A Generalization of the Two Trials Paradigm	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
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	4
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	4
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions	4
Bayesian Strategies in Rare Diseases	4
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	4
Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers	4
Value of Data Sharing to Advance Drug Development: A Regulatory Perspective	4
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	4
Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study	4
Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis	4
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response	4
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	4
elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials	4
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	4
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy	4
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans	4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	4
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group	4
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	4
Opportunities and Risks of UK Medical Device Reform	4