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Funding a Registry. Stakeholders The utility of registry data is related to three factors: The utility of registry data is related to three factors: The.

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Presentation on theme: "Funding a Registry. Stakeholders The utility of registry data is related to three factors: The utility of registry data is related to three factors: The."— Presentation transcript:

1 Funding a Registry

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

3 S takeholders Ideally, identify these stakeholders at an early stage of the registry planning process 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 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. 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. 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 S takeholders 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. 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. 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 S takeholders Potential stakeholders Potential stakeholders Public health or regulatory authorities. Public health or regulatory authorities. Product manufacturers (drugs, devices). Product manufacturers (drugs, devices). Health care service providers. Health care service providers. Payer or commissioning authorities. Payer or commissioning authorities. Patients and/or advocacy groups. Patients and/or advocacy groups. Treating clinician groups. Treating clinician groups. Academic institutions or consortia. Academic institutions or consortia. Professional societies. Professional societies.

6 Examples of Registry Funding (Rare Disease) DescriptionFunderTypeDatesPurpose Gaucher diseaseGenzymeComm1991-Rare Disease Cystic FibrosisGenentechComm1993-2005Multipurpose Fabrey diseaseShire HGTComm2001-Enzyme replacement therapy outcomes

7 Examples of Registry Funding (Birth Defects) DescriptionFunderTypeDatesPurpose Bupropion in Pregnancy GSKComm1997-2007Birth defects ART in Pregnancy Abbott, Boehringer Ingelheim, BMS, Gilead, GSK, Merck, Pfizer, Roche Tibotec, Novartis Comm1989-Birth defects Ribivirin in Pregancy Hoffman-La Roche, Sandoz, Shering-Plough Comm2003-Birth defects

8 Examples of Registry Funding (Common Diseases) DescriptionFunderTypeDatesPurpose Follicular Lymphoma GenentechC2004-Multipurpose BPHSanofi-AventisC2004-2007Quality of Care Early evaluation of diabetes Astra-ZenecaC2004- Quality of Care, Outcomes Childhood asthmaPHO (Cincinnati)HMO2003- Quality of care and outcomes Avian Flu Hoffman- LaRoche C2007-Emerging ID HIV/AIDS (CNICS)NIHGovt2007-Outcomes HIV/AIDS (EuroSIDA) Ministries of Health, Pharma Govt Com 2000-Outcomes Coronary StentingCordisComm2004-2006Emboli protection

9 Examples of Registry Funding (Specific Treatments) DescriptionFunderTypeDatesPurpose Erythropoiesis- stimulating therapies Ortho-BiotechComm2003-2009 Outcomes in oncology Palivizumab Outcomes MedimmuneComm2000-2004 RSV treatment in children Total Joint Replacement Kaiser Heatlh Plan 2001- Safety and Quality AZT for HIVBurroughs- Wellcome Comm1987-1991Safety

10 Examples of Registry Funding (Multi-Disease) DescriptionFunderTypeDatesPurpose Maine Health Clinical Improvements Registry MaineHealth and Maine Med. Ctr. Heath Plan 2003 Multipurpose for primary care in opt setting AE Spontaneous event reporting system BW Hospital, Partner’s Heath Health Plan 2008-Drug AEs GPD (England)Ministry of Health Govt2000-Quality of Care, Safety, Outcomes

11 Examples of Registry Funding (Multi-Disease) DescriptionFunderTypeDatesPurpose Group Health Cooperative (WA) GHP Health Plan 1990- Quality of care, safety, Outcomes Kaiser- Permanente (CA) KP Health Plan 1990- Qualtiy of care, safety, Outcomes Medicaid (COMPASS) FDA, CMS, Pharma Govt Com 1985- Safety, Outcomes Saskatchewan Ministry of Health Govt1980- Safety, Outcomes AE Spontaneous event reporting system BW Hospital, Partner’s Heath Health Plan 2008-Drug AEs

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

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

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

15 Johns Hopkins AIDS Service Johns Hopkins AIDS Service Locations Locations Johns Hopkins Hospital Johns Hopkins Hospital Greenspring Station Greenspring Station Maryland County Health Departments Maryland County Health Departments 911 Broadway 911 Broadway Care Care Integrated primary care (ID,GIM) and specialty care Integrated primary care (ID,GIM) and specialty care Psychiatry, neurology, dermatology, viral hepatitis, gynecology, nephrology, endocrinology Psychiatry, neurology, dermatology, viral hepatitis, gynecology, nephrology, endocrinology On-site pharmacy, Case management, Medication adherence program, Mental health services, Substance abuse services 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 Our Goal was to create a Longitudinal person-specific database on HIV-infected persons in an era or new treatments for HIV Purpose Purpose Assess therapeutic effectiveness Assess therapeutic effectiveness Safety/toxicity of therapy Safety/toxicity of therapy Factors that affect the above Factors that affect the above Comparisons between IDU and non-IDU patients of special interest Comparisons between IDU and non-IDU patients of special interest Costs and cost-effectiveness of care Costs and cost-effectiveness of care

17 Johns Hopkins HIV Clinical Cohort Origin is enrollment into the HIV Clinic 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: Data on exposure (medications), outcomes (disease progression), confounders (demographics, other clinical, etc.) collected from all available sources by: Manual abstraction of medical records (1989) Manual abstraction of medical records (1989) 1987- Industry -Pharmaceutical 1987- Industry -Pharmaceutical 1989 – State Government (Maryland Health Dept) 1989 – State Government (Maryland Health Dept) Vital statistics registries (1990) Vital statistics registries (1990) 1993- AHRQ RFA – Post-Licensing Drug Surveillance grant 1993- AHRQ RFA – Post-Licensing Drug Surveillance grant Electronic data: Hospitalization (1995) Electronic data: Hospitalization (1995) Electronic data: Some laboratory (1995) Electronic data: Some laboratory (1995) 1998 – NIH R01 - Investigator-initiated to analyze HIV treatment and outcomes. 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 interview data (1998) Supplemental collection of specimens (1998) Supplemental collection of specimens (1998) NIH R01 Supplement to main grant NIH R01 Supplement to main grant Disease registry (1999) Disease registry (1999) Electronic data: Most laboratory data (2000- 2005) Electronic data: Most laboratory data (2000- 2005) 2003 NIH R01 renewed 2003 NIH R01 renewed 2004 NIH R21 NIAAA 2004 NIH R21 NIAAA Electronic data: Pharmacy (2006) Electronic data: Pharmacy (2006) Electronic data: Clinical diagnoses, other Electronic data: Clinical diagnoses, other 2007 NIH R01 from NIAAA 2007 NIH R01 from NIAAA 2008 NIH R01 renewed 2008 NIH R01 renewed

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

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

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


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