2016 CURE OM Scientific Meeting

The CURE OM Registry

Jacqueline Kraska – CURE OM Advisor on Patient Centered Outcomes Research

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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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 3

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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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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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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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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CURE OM Registry Plan

Next steps:

1. Finalize registry objectives

• FDA grant

• Questionnaire

• Working group

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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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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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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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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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CURE OM Registry outcomes

ResultsKnowledgeEmpowerment Advocacy Policy Change Funding CollaborationsMore research

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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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