Therapeutic Innovation & Regulatory Science

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 2020-03-01 to 2024-03-01.)
ArticleCitations
The Use of External Controls in FDA Regulatory Decision Making53
Real World Evidence in Medical Cannabis Research37
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design34
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials30
Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative23
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action19
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 Regulati16
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View16
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 201916
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors15
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies15
Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review14
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation14
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative13
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry13
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters13
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments13
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements12
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action12
Effective Data Sharing as a Conduit for Advancing Medical Product Development12
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future12
Assessing the Financial Value of Decentralized Clinical Trials12
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications11
New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-1911
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting11
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 Disease11
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities11
Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?11
Drivers of Start-Up Delays in Global Randomized Clinical Trials10
FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals10
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine10
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned10
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 20219
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness9
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic9
Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis9
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 20209
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–20169
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion9
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy Groups9
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial9
Innovation Pathways in the NHS: An Introductory Review9
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases9
Extrapolation as a Default Strategy in Pediatric Drug Development9
Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes9
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity8
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle8
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum8
Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative8
Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores8
Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies8
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China8
Bridging the Gap Between RCTs and RWE Through Endpoint Selection8
Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide7
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators7
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development7
The Role of Master Protocols in Pediatric Drug Development7
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 Disease7
Addressing Bias in Responder Analysis of Patient-Reported Outcomes7
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform7
Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan7
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials7
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies7
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development7
Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies7
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity7
Factors Affecting Success of New Drug Clinical Trials7
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives6
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation6
Analysis of Pediatric Drug Approval Lag in Japan6
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring6
Update of EMA’s Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use6
Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa6
Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)6
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-196
Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 20176
FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science6
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children6
Collection of Post-treatment PRO Data in Oncology Clinical Trials6
Risk-Based Monitoring in Clinical Trials: 2021 Update6
Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic6
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey5
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials5
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration5
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further5
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population5
The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing5
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?5
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines5
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan5
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning5
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-195
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey5
Text Classification for Clinical Trial Operations: Evaluation and Comparison of Natural Language Processing Techniques5
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims5
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia5
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation5
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
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics5
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach5
Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS5
Anti-lung Cancer Marine Compounds: A Review5
Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines5
Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective5
Determining Minimum Wear Time for Mobile Sensor Technology5
Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015–20194
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically4
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development4
Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial Data4
Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies4
Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance4
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) Study4
A Tutorial on Modern Bayesian Methods in Clinical Trials4
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training4
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA4
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities4
Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance4
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups4
Trends and Characteristics of New Drug Approvals in China, 2011–20214
Improving Development of Drug Treatments for Pregnant Women and the Fetus4
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER4
Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions4
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe4
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance4
Protocol Deviations: A Holistic Approach from Defining to Reporting4
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 Japan4
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