This document discusses using innovative hybrid observational research models that directly involve patients to collect real-world data for healthcare effectiveness and outcomes research (HEO/CER). It notes the increased demand for real-world data and reduced time and funding for research. It proposes directly engaging patients through technology to design more effective studies, supplement recruitment, enable proactive retention, and involve patients during and after studies. This direct-to-patient approach could provide faster enrollment, increased retention, and lower costs while balancing limitations like data completeness and lack of randomization. The approach combines patient-reported outcomes, lab data, electronic medical records, and device-collected data to streamline product development and prove value and safety.

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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4. Balanced Challenge in Support of HEO/CER
Increased
Demand for
Real-world Data
Less Time &
Reduced
Funding

5. #012-064

6. Direct-to-Patient Research

7. Innovation with Patients

8. Innovation with Technology

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

11. 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

12. 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

13. Q&A