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

4. #012-064

5. Direct-to-Patient Research

6. Innovation with Patients

7. Innovation with Technology

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

9. Direct-to-Patient | PRO+Chart+Lab

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

11. Patient
Reported
Outcomes
Lab Data
Electronic
Medical Records
Device-
Collected Data
Streamline Product
Development
Prove Product
Value and Safety
Accelerate Adoption
and Build Adherence
MediGuard.org Patient Communities ClinicalResearch.com
Direct-to-Patient Innovation to Support HEO/CER

12. Q&A