Therapeutic Innovation & Regulatory Science

Article	Citations
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	58
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	53
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	50
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	47
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	47
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	43
Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals	39
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	36
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial	36
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	34
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	32
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	30
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	28
Accelerating Global Access for Indication Extension Through Regulatory Reliance Pilot: The First Indication Extension Pilot in Oncology	26
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers	26
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	25
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	25
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	25
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	21
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	19
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	19
Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example	19
Impact of Japanese Subpopulation Data and Overall Survival in Pivotal Trials on Oncology Drug Approvals in Japan	19

Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change	19
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	17
Correction: Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	17
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines	17
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	17
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	15
Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences	15
New Estimates on the Cost of a Delay Day in Drug Development	15
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	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
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	14
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	14
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	14
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
Clinicians’ Reactions to Point-of-Care Advertising in Electronic Health Records	13
Dasatinib-Associated Chylothorax: A Scoping Review and Pharmacovigilance Analysis	12
Overdosage Section in US and EU Labeling	11
Advancing Biomarker Qualification: FDA Perspective on Efficiency, Surrogate Endpoints, and Future Directions	11
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	11
Japanese Regulatory Considerations for Interoperability of Medical Devices	10
Training New DMC Members: A Call to Action	10
Performance Evaluation of Interim Analysis in Bioequivalence Studies	10
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	10
Transforming Objective Participatory Patient Advocacy	10
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)	10
Risk Management in Drug-Device Combination Product Development	10
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	10
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	10
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	9
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	9
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	9
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	9
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	9
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	8
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	8
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence 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
Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective	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
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8
Digital Tools—Regulatory Considerations for Application in Clinical Trials	8
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	8
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	8
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	8
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	7

Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	7
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	7
Risk-Based Quality Management: A Case for Centralized Monitoring	7
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland	7
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	7
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	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
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
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	7
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
Statistical Analysis for Rating Scale in Clinical Trials	7
Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective	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
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	7
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	6
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	6
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	6
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools	6
Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development	6
Improving Informed Consent for English and Spanish Speakers in Clinical Trials	6
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	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
Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania	6
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	6
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	6
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data	5
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	5
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan	5
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review	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
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	5
Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET®	5
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	5
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	5
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	5
Beyond the Data: Addressing Ethical Concerns in Clinical Trials	5
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials	5
Arbitrated Indirect Treatment Comparisons	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
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
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	5
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	5
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	5
Bayesian Clinical Trials	5
Correction: Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges	5
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Drug Repurposing in Oncology: A Strategic Pathway to Unlocking New Therapeutic Potential	4
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials	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
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
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	4
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations	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
Comparative Assessment of the Pharmaceutical Quality of Amoxicillin Capsules Marketed in Authorized and an Unregulated Point of Sale in Mexican Market	4
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results	4
Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences	4
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm 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
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
Patent Analysis Perspectives on China’s Orphan Drug R&D: Status and Technology Characteristics	4
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data	4
Innovative Multidimensional Quantitative Benefit-Risk Model for Effective Decision Making in Research and Development for Biopharmaceutical Industry	4
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	4
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023	4

A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4