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 2020-05-01 to 2024-05-01.)

Article	Citations
The Use of External Controls in FDA Regulatory Decision Making	56
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design	38
Real World Evidence in Medical Cannabis Research	38
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials	31
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	20
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	20
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	19
Assessing the Financial Value of Decentralized Clinical Trials	18
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019	17
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry	15
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	15
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review	15
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	14
Effective Data Sharing as a Conduit for Advancing Medical Product Development	14
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation	14
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments	14
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative	13
Drivers of Start-Up Delays in Global Randomized Clinical Trials	13
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters	13
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future	13
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements	12
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities	12
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications	12
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	12
Innovation Pathways in the NHS: An Introductory Review	11

New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19	11
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting	11
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle	11
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	11
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021	10
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum	10
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	10
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020	10
FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals	10
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion	9
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy Groups	9
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity	9
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial	9
Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative	9
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	9
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic	9
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform	9
Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes	9
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016	9
A Tutorial on Modern Bayesian Methods in Clinical Trials	9
Extrapolation as a Default Strategy in Pediatric Drug Development	9
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies	9
Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies	9
Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis	9
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	9
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	8
Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores	8
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	8
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity	8
Factors Affecting Success of New Drug Clinical Trials	8
Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017	8
Bridging the Gap Between RCTs and RWE Through Endpoint Selection	8
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	7
Update of EMA’s Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use	7
The Role of Master Protocols in Pediatric Drug Development	7
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	7
Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide	7
Addressing Bias in Responder Analysis of Patient-Reported Outcomes	7
Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies	7
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development	7
FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science	7
Collection of Post-treatment PRO Data in Oncology Clinical Trials	7
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	7
Risk-Based Monitoring in Clinical Trials: 2021 Update	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
Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)	7
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development	7
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children	6
Analysis of Pediatric Drug Approval Lag in Japan	6

Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic	6
Anti-lung Cancer Marine Compounds: A Review	6
MedDRA Labeling Groupings to Improve Safety Communication in Product Labels	6
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation	6
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?	6
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives	6
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	6
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims	6
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing	6
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring	6
Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS	6
Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance	5
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials	5
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach	5
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further	5
Text Classification for Clinical Trial Operations: Evaluation and Comparison of Natural Language Processing Techniques	5
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing	5
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER	5
Since the Mid-2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to Analyze Their Effectiveness?	5
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey	5
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan	5
Improving Development of Drug Treatments for Pregnant Women and the Fetus	5
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration	5
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey	5
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	5
Determining Minimum Wear Time for Mobile Sensor Technology	5
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities	5
Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial Data	5
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	5
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning	5
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	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
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training	5
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines	5
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation	5
Bayesian Strategies in Rare Diseases	4
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	4
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe	4
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy	4
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	4
Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance	4
Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015–2019	4
Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions	4
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA	4
The Competency of Clinical Research Coordinators: The Importance of Education and Experience	4
Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies	4
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	4
Trends and Characteristics of New Drug Approvals in China, 2011–2021	4
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response	4
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	4
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	4
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development	4
Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers	4
Protocol Deviations: A Holistic Approach from Defining to Reporting	4
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	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
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	4