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Publications by Nicolle M. Gatto
A Structured Pre‐ and Post‐Approval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions
Clinical Pharmacology and Therapeutics
Pharmacology
Is the “Well-Defined Intervention Assumption” Politically Conservative?
Social Science and Medicine
Medicine
Philosophy of Science
Health
History
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Prm15 - Pre-Approval Simulation of Real-World Outcomes: Development of a Methodological Framework
Value in Health
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A Framework to Guide the Optimal Development and Use of Real-World Evidence for Drug Coverage and Formulary Decisions
Journal of Comparative Effectiveness Research
Health Policy
Real-World Evidence to Guide the Approval and Use of New Treatments
NAM Perspectives
Pcp53 - A Diagnostic Framework to Evaluate Real-World Data Sources for Real-World Evidence Generation
Value in Health
Medicine
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Modernizing Regulatory Evidence With Trials and Real-World Studies
Therapeutic Innovation and Regulatory Science
Pharmacology
Public Health
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Toxicology
Pharmaceutics
Occupational Health
A Leadless Pacemaker in the Real-World Setting: The Micra Transcatheter Pacing System Post-Approval Registry
Heart Rhythm
Cardiovascular Medicine
Physiology
Cardiology
Real-World Treatment Patterns, Cost of Care and Effectiveness of Therapies for Patients With Squamous Cell Carcinoma of Head and Neck Pre and Post Approval of Immuno-Oncology Agents
Journal of Medical Economics
Health Policy
Building Trust in Real-World Evidence and Comparative Effectiveness Research: The Need for Transparency
Journal of Comparative Effectiveness Research
Health Policy
Study Verifies Value of Real-World Evidence
Cancer Discovery
Oncology
