Work Directly with Patients to Collect
HEO/CER Data Using Innovative Hybrid
Observational Research Models
John Reites
Quin...
Disclaimer
• The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and...
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 Effecti...
Direct-to-Patient | PRO+Chart+Lab
Balance with Direct-to-Patient Research
Benefits
• More rapid study launch and
shortened timelines
• Decreased costs compa...
Patient
Reported
Outcomes
Lab Data
Electronic
Medical Records
Device-
Collected Data
Streamline Product
Development
Prove ...
Q&A
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Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research Models

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

  1. 1. Work Directly with Patients to Collect HEO/CER Data Using Innovative Hybrid Observational Research Models John Reites Quintiles Director of Operations Communications
  2. 2. 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.
  3. 3. Balanced Challenge in Support of HEO/CER Increased Demand for Real-world Data Less Time & Reduced Funding
  4. 4. #012-064
  5. 5. Direct-to-Patient Research
  6. 6. Innovation with Patients
  7. 7. Innovation with Technology
  8. 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. 9. Direct-to-Patient | PRO+Chart+Lab
  10. 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. 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. 12. Q&A

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