Jacqueline Kraska provides an update on the CURE OM Patient Registry at the 2017 CURE OM Patient & Caregiver Symposium.

1. 2016 CURE OM Scientific Meeting
The CURE OM Registry
Jacqueline Kraska – CURE OM Advisor on Patient Centered Outcomes Research

2. Agency for Healthcare Research and Quality – Community Forum White Paper
“Experts agree that patient-powered registries are
transforming patient/caregiver support and advocacy
groups into research organizations. They also provide
patients and family members another way to become
engaged in research beyond the role of advisor or
informant to research-generated studies.”
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3. Patient registry
“An organized system that uses observational study
methods to collect uniform data (clinical and other)
to evaluate specified outcomes for a population
defined by a particular disease, condition, or
exposure, and that serves a predetermined
scientific, clinical, or policy purpose(s).”
Registries for Evaluating Patient Outcomes: A User’s Guide – AHRQ
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4. Patient-powered registry
Patient-powered registries are developed,
sponsored and managed by patients, family
members and advocacy organizations in
collaboration with disease experts. The patient
community drives the collection, maintenance,
analysis and dissemination of research data.
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5. Type of study data
Demographics and patient history
Diagnosis
Treatment and patient outcomes
The natural history of disease
Clinical and/or cost-effectiveness
Assessing safety or harm
Standards of care
Patient preferences
Policy
Recruitment vehicle for existing clinical trials
Repository for samples of blood or tissue
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6. CURE OM Patient Registry Objectives
Develop a centralized and secure database that will collect, store, and allow for
analysis to better understand the natural history of ocular melanoma
Define OM patient population
Increase likelihood of development of effective treatments
Create standards of care at different stages – providing opportunities to advocate
for better insurance coverage for patients.
Increase collaborative efforts between patients, clinicians, and researchers
Understand patient preferences
Inform research priorities
Provide longitudinal view into relationship between genotype and phenotype
Attract new investigators to the field
Inform policy
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7. CURE OM Registry Plan
Steps completed so far:
1. Decision to have a patient reported registry
2. Initial funds raised for initiative
3. Building support and resources
4. Defined registry objectives and delivery plan
5. Partnering with academic/clinical registry
6. Formed multi-disciplinary Registry Working Group
7. Developed questionnaire for wider input
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8. CURE OM Registry Plan
Next steps:
1. Finalize registry objectives
• FDA grant
• Questionnaire
• Working group
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9. CURE OM Registry Plan
Next steps:
2. Develop registry protocol & study docs
• Intro & background
• Study design
• Data set: collection (what, who, when, where) &
management – reliable and quality
• Eligibility & consent
• Governance
• Data analysis, reporting & sharing
• Communications
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10. CURE OM Registry Plan
Next steps:
3. Select registry tool or provider/host
• User friendly – patient reported
• Safe – protect patient confidentiality
• Informative & engaging – retention
• Compatible with other systems
• Innovative – future initiatives
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11. CURE OM Registry Plan
Next steps:
4. Engage, launch & retain
• Initiate communication plan
• Training, test & launch of registry
• Day to day management of registry
• Long term sustainable funding
• Retention strategy: communication, education,
research, data results & developments
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12. CURE OM Registry Plan
Next steps:
5. Data analysis, dissemination & collaboration
• Analyze data – CURE OM & integration with partners
• Produce & disseminate reports for various parties
• Foster collaborations with researchers, clinicians,
industry, advocacy organizations etc.,
• Protocol developments & further research
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13. CURE OM Registry outcomes
Results
Knowledge
Empowerment
Advocacy
Policy
Change
Funding
Collaborations
More research
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14. CURE OM Goals
Improve patient-centered research in
ocular melanoma
Improve patient outcomes in ocular
melanoma
Improved clinical care and quality of life
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