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 2021-04-01 to 2025-04-01.)

Article	Citations
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	80
Points to Consider on the Use of Medicines in Pregnancy Throughout the Product Lifecycle Based on Global Regulatory Guidance	52
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	48
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information	35
Data Monitoring Committee Reports: Telling the Data’s Story	30
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	29
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China	28
An Extended Framework of Multiple Testing in Group Sequential Design	27
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	26
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	24
Adoption of Decentralization: Are Our Perceptions Holding Us Back?	24
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	23
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space	22
The Data Monitoring Committee: A Collective or a Collection?	22
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in	22
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis	22
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	22
The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power	20
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	18
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	17
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities	16
Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century	16
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?	15
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines	15
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	15

Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	14
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: “It’s About Time we Bring Trials to People”	14
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates	14
Quantifying Site Burden to Optimize Protocol Performance	14
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters	13
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database	12
Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan	12
Anti-lung Cancer Marine Compounds: A Review	12
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies	11
Data-Driven Subgroup Identification in Confirmatory Clinical Trials	11
Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial	11
Evaluating Metrics Applied to the Medical Science Liaison (MSL) Role: A Survey-Based Study of Canadian MSL Leaders	11
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response	11
Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes	11
Solution Oligonucleotide APIs: Regulatory Considerations	11
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials	11
Opportunities and Risks of UK Medical Device Reform	11
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	10
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	10
Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials	10
Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis	10
Impact of Tumor Assessment Frequency on Statistical Power in Randomized Cancer Clinical Trials Evaluating Progression-Free Survival	9
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	9
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	9
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	9
Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefi	9
A Tutorial on Modern Bayesian Methods in Clinical Trials	9
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	9
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	9
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	9
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials	9
Adaptation of the WOMAC for Use in a Patient Preference Study	9
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	9
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	8
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	8
Bayesian Clinical Trials	8
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids	8
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan	8
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information	8
Correction: Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters	8
Sample Sizes Using Hochberg’s Procedure for Two Comparisons with Three Different Study Designs	8
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka	8
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	7
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	7
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	7
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History	7
Review of the European Union Clinical Trials Regulation: Key Early Learnings from the United Kingdom Drug Information Association Medical Writing Committee	7
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	7
Insights into Early Interactions on Innovative Developments with European Regulators	7
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion	7

Catering the Need of Drug Manufacturing Standard in India: An Update to Indian Pharmacopoeia	7
Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation	7
Leveraging Real-World Data in Safety Signal Assessment	7
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	6
Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies	6
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development	6
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective	6
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency	6
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	6
Factors Affecting Success of New Drug Clinical Trials	6
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	6
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	6
Response to the Letter to the Editor by Koneswarakantha and Ménard	6
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	6
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	6
Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements - Outcomes of a Descriptive Review	5
Decentralized Clinical Trials in the Development of Drugs and Biological Products	5
Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
The Medical Science Liaison Role in Spain: A Survey About the Opinion of HealthCare Professionals	5
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials	5
Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives	5
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Accelerating Pediatric Drug Development: A 2022 Special Issue of Therapeutic Innovation & Regulatory Science	5
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	5
Comparison of Borrowing Methods for Incorporating Historical Data in Single-Arm Phase II Clinical Trials	5
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future	5
Assessing the Financial Value of Decentralized Clinical Trials	5
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective	5
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	5
A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Grou	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
Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act	5
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach	5
The Implementation of the 2020 Roadmap to Promote Good Registration Management (GRM) in APEC Region	5
Sponsor- vs. FDA-Initiated Changes to Pediatric Clinical Trial Protocols: A Comparison of Associated Participant Burden	5
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group	4
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	4
Ascertaining Nonfatal Endpoints in Clinical Trials: Central Adjudication Versus Patient Insurance Claims	4
Cutting Through the “Gray Area”: An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research	4
Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies	4
Delivering Digital Health Solutions that Patients Need: A Call to Action	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
Evaluation of FDA Labeling Changes Related to PREA Safety–Waivers	4
Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples Based on a Psychiatric Disorder	4
Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box	4
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity	4
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	4
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings	4
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	4
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?	4
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan	4
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	4
Improving Development of Drug Treatments for Pregnant Women and the Fetus	4
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	4
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	4
Utility-Based Dose Selection for Phase II Dose-Finding Studies	4
The Role of Master Protocols in Pediatric Drug Development	4
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	4
Pharmacometrics: The Already-Present Future of Precision Pharmacology	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