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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Balanced Challenge in Support of HEO/CER

Increased Demand for

Real-world Data

Less Time & Reduced Funding

#012-064

Direct-to-Patient Research

Innovation with Patients

Innovation with Technology

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

Direct-to-Patient | PRO+Chart+Lab

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

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

Q&A