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Funding a Registry

Funding a Registry. Stakeholders. The utility of registry data is related to three factors: The primary scientific question, The context. The stakeholders - those associated with the disease or procedure that may be affected from a patient, provider, payer, regulator, or other perspective.

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Funding a Registry

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  1. Funding a Registry

  2. Stakeholders • The utility of registry data is related to three factors: • The primary scientific question, • The context. • The stakeholders - those associated with the disease or procedure that may be affected from a patient, provider, payer, regulator, or other perspective. • To identify potential stakeholders, it is important to consider to whom the research questions matter.

  3. Stakeholders • Ideally, identify these stakeholders at an early stage of the registry planning process • They may have important input into the type and scope of data to be collected, • They may ultimately be users of the data, and/or they may have a key role in disseminating the results of the registry. • One or more parties could be considered stakeholders of the registry. These parties could be as specific as a regulatory agency monitoring postmarketing studies, industry, patients or support groups with the conditions of interest.

  4. Stakeholders Often, a stakeholder’s input directly influences whether development of a registry can proceed, and it can have a strong influence on how a registry is conducted. A regulatory agency looking for management of a drug with a known toxicity profile may require a different registry design than a manufacturer with general questions about how a product is being used.

  5. Stakeholders • Potential stakeholders • Public health or regulatory authorities. • Product manufacturers (drugs, devices). • Health care service providers. • Payer or commissioning authorities. • Patients and/or advocacy groups. • Treating clinician groups. • Academic institutions or consortia. • Professional societies.

  6. Examples of Registry Funding(Rare Disease)

  7. Examples of Registry Funding(Birth Defects)

  8. Examples of Registry Funding(Common Diseases)

  9. Examples of Registry Funding(Specific Treatments)

  10. Examples of Registry Funding(Multi-Disease)

  11. Examples of Registry Funding(Multi-Disease)

  12. Funding • Commercial • Highly targeted • Short(er) term (but not always) • Less control by investigator? • Health Plan • Less targeted • Longer-term • Investigator may need to be part of the plan

  13. Funding • Foundation • Targeted • Short(er) term • Less support available • Government • Federal • State • Local

  14. HIV/AIDS Registry • Over 31,000 living PLWA/PLWH in Maryland 2009 • 62% of these in Central MD • 32 per 100,000 in Baltimore (5th of urban centers

  15. Johns Hopkins AIDS Service • Locations • Johns Hopkins Hospital • Greenspring Station • Maryland County Health Departments • 911 Broadway • Care • Integrated primary care (ID,GIM) and specialty care • Psychiatry, neurology, dermatology, viral hepatitis, gynecology, nephrology, endocrinology • On-site pharmacy, Case management, Medication adherence program, Mental health services, Substance abuse services

  16. Johns Hopkins HIV Clinical Cohort • Our Goal was to create a Longitudinal person-specific database on HIV-infected persons in an era or new treatments for HIV • Purpose • Assess therapeutic effectiveness • Safety/toxicity of therapy • Factors that affect the above • Comparisons between IDU and non-IDU patients of special interest • Costs and cost-effectiveness of care

  17. Johns Hopkins HIV Clinical Cohort • Origin is enrollment into the HIV Clinic • Data on exposure (medications), outcomes (disease progression), confounders (demographics, other clinical, etc.) collected from all available sources by: • Manual abstraction of medical records (1989) • 1987- Industry -Pharmaceutical • 1989 – State Government (Maryland Health Dept) • Vital statistics registries (1990) • 1993- AHRQ RFA – Post-Licensing Drug Surveillance grant • Electronic data: Hospitalization (1995) • Electronic data: Some laboratory (1995) • 1998 – NIH R01 - Investigator-initiated to analyze HIV treatment and outcomes.

  18. Johns Hopkins HIV Clinical Cohort Supplemental collection of interview data (1998) Supplemental collection of specimens (1998) NIH R01 Supplement to main grant Disease registry (1999) Electronic data: Most laboratory data (2000-2005) 2003 NIH R01 renewed 2004 NIH R21 NIAAA Electronic data: Pharmacy (2006) Electronic data: Clinical diagnoses, other 2007 NIH R01 from NIAAA 2008 NIH R01 renewed

  19. Johns Hopkins HIV Clinical Cohort 2000- CDC Grant HIV outcomes 2001-AHRQ Contract - HIV health resources/outcomes 2006- NIAID R24 Collaboration of HIV cohorts across US 2007 – NIAID/NCI U01 for Global Collaboration of HIV cohorts

  20. Medical Records Abstraction: Johns Hopkins, Outside Facilities ACASI: ARV Adherence, Smoking, Alcohol, Substance Use QOL, Depression Electronic Patient Data: Laboratory, Radiology, Pathology, Microbiology, Pharmacy, Hospitalizations Data Abstractors Vital Statistics: Maryland, NDI, Social Security Data Entry JHHCC Johns Hopkins HIV Clinical Cohort (in 2010) NA-ACCORD HIVRN CNICS IeDEA Sample Size: 6,800 Publications: > 300 Person-Time: 65,000 PY Support: > $5,000,000 (annual)

  21. Summary You NEED support! You may be able to get started with institutional funds, but these may not get you very far. There are sources of support, but they must be stakeholders in what you want to accomplish. You must be imaginative in thinking about stakeholders/funders You can fund for a targeted reason, but expand to multi-purposes over time Support will expand as you expand

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