Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research...

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Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research Models John Reites Quintiles Director of Operations Communications

Transcript of Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research...

Page 1: Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research Models

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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Disclaimer

• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Communities (formerly known as SIACs) or affiliates, or any organization with which the presenter is employed or affiliated.

• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.

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Balanced Challenge in Support of HEO/CER

Increased Demand for

Real-world Data

Less Time & Reduced Funding

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#012-064

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Direct-to-Patient Research

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Innovation with Patients

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Innovation with Technology

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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

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Direct-to-Patient | PRO+Chart+Lab

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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

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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

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Q&A