Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling 2012 is a webinar that covers topics such as:
- Reliability, Validity, and Sensitivity
- PRO instruments: Conceptual framework, endpoint models
- Protocol Considerations
- Existing instruments, modified instruments, and newly created instruments. Types of evidence needed for FDA review
- Multiple and Composite Endpoints
- Electronic Data Capture
- Interpretation of Clinical Trial Results
- Statistical Considerations: SAPs
Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling 2012 brings together:
- Clinical Research Professionals
- Pharmaceutical and Medical Device Company Representatives and Decision-Makers
- Clinical Study Managers
- Clinical Protocol Developers
- Clinical Studies Directors
- Regulatory Managers
- Anyone seeking to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device
- Biostatisticians
