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Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research Models
1. Work Directly with Patients to Collect
HEO/CER Data Using Innovative Hybrid
Observational Research Models
John Reites
Quintiles
Director of Operations
Communications
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3. Balanced Challenge in Support of HEO/CER
Increased
Demand for
Real-world Data
Less Time &
Reduced
Funding
8. Innovation for research data collection
Benefits
Faster
Enrollment
Increased
Retention
Decreased
Costs
Design More Effective Studies with Patient Input
Supplement Recruitment via Patient Outreach
Engage Patients Directly to Enable Pro-active Retention
Patient Engagement During and Post Study
Innovation via Hybrid Observational Study Completion
Remote/Virtual Visits to Reduce Site/Patient Burden
Direct-to-Patient Approach as a Solution
10. Balance with Direct-to-Patient Research
Benefits
• More rapid study launch and
shortened timelines
• Decreased costs compared to the
physician-centric model
• Strong patient interest in method
• Helping others
• Direct participation in the
research process
• Alignment of patient incentives
• Comprehensive condition
monitoring and tracking
• Patient perspective directly
provided
Limitations
• Questions about data
completeness
• Verification of patient diagnosis
• Self-reported data
• Length of recall
• Lack of randomization
• No physician involvement
• Regulatory requirements in
process of being defined in some
countries