A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness

Keyphrases

• Clinical Trials 100%
• Design Decisions 50%
• Direct-to-patient 50%
• Fit-for-purpose 50%
• Health Decision-making 50%
• International Society 50%
• Long-run Risk 50%
• Long-term Benefit 50%
• Long-term Efficacy 100%
• Long-term Safety 100%
• Methodological Considerations 50%
• Operational Guidance 50%
• Pharmacoepidemiology 50%
• Population Level 50%
• Post-approval Changes 50%
• Safety Requirements 50%
• Scientific Guidance 50%
• Tolerability 50%
• Traditional Clinical 50%
• Treatment Device 50%

Computer Science

• Data Source 100%
• Decision-Making 100%
• Individual Level 100%
• Population Level 100%

Pharmacology, Toxicology and Pharmaceutical Science

• Clinical Trial 100%
• Pharmacoepidemiology 50%
• Tolerability 50%