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

Keyphrases

• Long-term Safety 100%
• Long-term Efficacy 100%
• World Data 100%
• Clinical Trials 66%
• Population Level 33%
• Pharmacoepidemiology 33%
• Methodological Considerations 33%
• Design Decisions 33%
• International Society 33%
• Long-term Benefit 33%
• Long-run Risk 33%
• Post-approval Changes 33%
• Safety Requirements 33%
• Operational Guidance 33%
• Fit-for-purpose 33%
• Scientific Guidance 33%
• Safety/tolerability 33%
• Traditional Clinical 33%
• Healthcare Decision-making 33%
• Treatment Devices 33%

Pharmacology, Toxicology and Pharmaceutical Science

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