Funding a RegistryFunding a Registry

StakeholdersStakeholders The utility of registry data is related The utility of registry data is related

to three factors: to three factors: The primary scientific question, The primary scientific question, The context. The context. The stakeholders - those associated The stakeholders - those associated

with the disease or procedure that may with the disease or procedure that may be affected from a patient, provider, be affected from a patient, provider, payer, regulator, or other perspective.payer, regulator, or other perspective.

To identify potential stakeholders, it To identify potential stakeholders, it is important to consider to whom the is important to consider to whom the research questions matter. research questions matter.

SStakeholderstakeholders Ideally, identify these stakeholders at an Ideally, identify these stakeholders at an

early stage of the registry planning early stage of the registry planning process process They may have important input into the type They may have important input into the type

and scope of data to be collected, and scope of data to be collected, They may ultimately be users of the data, They may ultimately be users of the data,

and/or they may have a key role in and/or they may have a key role in disseminating the results of the registry. disseminating the results of the registry.

One or more parties could be considered One or more parties could be considered stakeholders of the registry. These parties stakeholders of the registry. These parties could be as specific as a regulatory agency could be as specific as a regulatory agency monitoring postmarketing studies, industry, monitoring postmarketing studies, industry, patients or support groups with the conditions patients or support groups with the conditions of interest. of interest.

SStakeholderstakeholders Often, a stakeholder’s input directly Often, a stakeholder’s input directly

influences whether development of a influences whether development of a registry can proceed, and it can have a registry can proceed, and it can have a strong influence on how a registry is strong influence on how a registry is conducted. conducted.

A regulatory agency looking for A regulatory agency looking for management of a drug with a known toxicity management of a drug with a known toxicity profile may require a different registry profile may require a different registry design than a manufacturer with general design than a manufacturer with general questions about how a product is being questions about how a product is being used.used.

SStakeholderstakeholders Potential stakeholdersPotential 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.

Examples of Registry Examples of Registry FundingFunding

(Rare Disease)(Rare Disease)Description Funder Type Dates PurposeGaucher disease Genzyme Comm 1991- Rare DiseaseCystic Fibrosis Genentech Comm 1993-2005 MultipurposeFabrey disease Shire HGT Comm 2001- Enzyme

replacement therapy outcomes

Examples of Registry Examples of Registry FundingFunding

(Birth Defects)(Birth Defects)Description Funder Type Dates PurposeBupropion in Pregnancy

GSK Comm 1997-2007 Birth defects

ART in Pregnancy Abbott, Boehringer Ingelheim , BMS, Gilead, GSK, Merck, Pfizer, Roche Tibotec, Novartis

Comm 1989- Birth defects

Ribivirin in Pregancy

Hoffman-La Roche, Sandoz, Shering-Plough

Comm 2003- Birth defects

Examples of Registry Examples of Registry FundingFunding

(Common Diseases)(Common Diseases)Description Funder Type Dates PurposeFollicular Lymphoma

Genentech C 2004- Multipurpose

BPH Sanofi-Aventis C 2004-2007 Quality of CareEarly evaluation of diabetes

Astra-Zeneca C 2004- Quality of Care, Outcomes

Childhood asthma PHO (Cincinnati) HMO 2003- Quality of care and outcomes

Avian Flu Hoffman-LaRoche

C 2007- Emerging ID

HIV/AIDS (CNICS) NIH Govt 2007- OutcomesHIV/AIDS (EuroSIDA)

Ministries of Health, Pharma

GovtCom

2000- Outcomes

Coronary Stenting Cordis Comm 2004-2006 Emboli protection

Examples of Registry Examples of Registry FundingFunding

(Specific Treatments)(Specific Treatments)

Description Funder Type Dates PurposeErythropoiesis-stimulating therapies

Ortho-Biotech Comm 2003-2009 Outcomes in oncology

Palivizumab Outcomes

Medimmune Comm 2000-2004 RSV treatment in children

Total Joint Replacement

Kaiser Heatlh Plan

2001- Safety and Quality

AZT for HIV Burroughs-Wellcome

Comm 1987-1991 Safety

Examples of Registry Examples of Registry FundingFunding

(Multi-Disease)(Multi-Disease)Description Funder Type Dates PurposeMaine 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

Govt 2000- Quality of Care, Safety, Outcomes

Examples of Registry Examples of Registry FundingFunding

(Multi-Disease)(Multi-Disease)Description Funder Type Dates PurposeGroup 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

GovtCom

1985- Safety, Outcomes

Saskatchewan Ministry of Health

Govt 1980- Safety, Outcomes

AE Spontaneous event reporting system

BW Hospital, Partner’s Heath

Health Plan

2008- Drug AEs

FundingFunding Commercial Commercial

Highly targetedHighly targeted Short(er) term (but not always)Short(er) term (but not always) Less control by investigator?Less control by investigator?

Health PlanHealth Plan Less targetedLess targeted Longer-termLonger-term Investigator may need to be part of Investigator may need to be part of

the planthe plan

FundingFunding FoundationFoundation

TargetedTargeted Short(er) termShort(er) term Less support availableLess support available

GovernmentGovernment FederalFederal StateState LocalLocal

HIV/AIDS RegistryHIV/AIDS Registry

Over 31,000 living PLWA/PLWH in Over 31,000 living PLWA/PLWH in Maryland 2009Maryland 2009

62% of these in Central MD62% of these in Central MD

32 per 100,000 in Baltimore (532 per 100,000 in Baltimore (5thth of urban of urban centerscenters

Johns Hopkins AIDS ServiceJohns Hopkins AIDS Service LocationsLocations

Johns Hopkins Hospital Johns Hopkins Hospital Greenspring Station Greenspring Station Maryland County Health Departments Maryland County Health Departments 911 Broadway911 Broadway

CareCare Integrated primary care (ID,GIM) and specialty careIntegrated primary care (ID,GIM) and specialty care Psychiatry, neurology, dermatology, viral hepatitis, Psychiatry, neurology, dermatology, viral hepatitis,

gynecology, nephrology, endocrinologygynecology, nephrology, endocrinology On-site pharmacy, Case management, Medication On-site pharmacy, Case management, Medication

adherence program, Mental health services, adherence program, Mental health services,

Substance abuse servicesSubstance abuse services

Johns Hopkins HIV Clinical CohortJohns Hopkins HIV Clinical Cohort

Our Goal was to create a Longitudinal Our Goal was to create a Longitudinal person-specific database on HIV-infected person-specific database on HIV-infected persons in an era or new treatments for HIVpersons in an era or new treatments for HIV

PurposePurpose Assess therapeutic effectiveness Assess therapeutic effectiveness Safety/toxicity of therapySafety/toxicity of therapy Factors that affect the aboveFactors that affect the above Comparisons between IDU and non-IDU Comparisons between IDU and non-IDU

patients of special interestpatients of special interest Costs and cost-effectiveness of careCosts and cost-effectiveness of care

Johns Hopkins HIV Clinical CohortJohns Hopkins HIV Clinical Cohort Origin is enrollment into the HIV ClinicOrigin is enrollment into the HIV Clinic Data on exposure (medications), outcomes (disease Data on exposure (medications), outcomes (disease

progression), confounders (demographics, other clinical, progression), confounders (demographics, other clinical, etc.) collected from all available sources by:etc.) collected from all available sources by:

Manual abstraction of medical records (1989)Manual abstraction of medical records (1989) 1987- Industry -Pharmaceutical1987- Industry -Pharmaceutical 1989 – State Government (Maryland Health 1989 – State Government (Maryland Health

Dept)Dept) Vital statistics registries (1990)Vital statistics registries (1990)

1993- AHRQ RFA – Post-Licensing Drug 1993- AHRQ RFA – Post-Licensing Drug Surveillance grantSurveillance 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 1998 – NIH R01 - Investigator-initiated to analyze HIV treatment and outcomes.analyze HIV treatment and outcomes.

Johns Hopkins HIV Clinical CohortJohns Hopkins HIV Clinical Cohort Supplemental collection of interview data Supplemental collection of interview data

(1998)(1998) Supplemental collection of specimens (1998)Supplemental collection of specimens (1998)

NIH R01 Supplement to main grantNIH R01 Supplement to main grant Disease registry (1999)Disease registry (1999)

Electronic data: Most laboratory data (2000-Electronic data: Most laboratory data (2000-2005)2005)

2003 NIH R01 renewed2003 NIH R01 renewed 2004 NIH R21 NIAAA2004 NIH R21 NIAAA

Electronic data: Pharmacy (2006)Electronic data: Pharmacy (2006) Electronic data: Clinical diagnoses, otherElectronic data: Clinical diagnoses, other

2007 NIH R01 from NIAAA2007 NIH R01 from NIAAA 2008 NIH R01 renewed2008 NIH R01 renewed

Johns Hopkins HIV Clinical CohortJohns Hopkins HIV Clinical Cohort

2000- CDC Grant HIV outcomes2000- CDC Grant HIV outcomes 2001-AHRQ Contract - HIV health 2001-AHRQ Contract - HIV health

resources/outcomesresources/outcomes 2006- NIAID R24 Collaboration of 2006- NIAID R24 Collaboration of

HIV cohorts across USHIV cohorts across US 2007 – NIAID/NCI U01 for Global 2007 – NIAID/NCI U01 for Global

Collaboration of HIV cohortsCollaboration of HIV cohorts

Johns Hopkins HIV Clinical Cohort Johns Hopkins HIV Clinical Cohort (in 2010)(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 UseQOL,

Depression

Vital Statistics:

Maryland,NDI,

Social Security

Sample Size: 6,800 Publications: > 300Sample Size: 6,800 Publications: > 300Person-Time: 65,000 PY Support: > $5,000,000 (annual)Person-Time: 65,000 PY Support: > $5,000,000 (annual)

NA-ACCORDHIVRNCNICSIeDEA

SummarySummary You NEED support!You NEED support! You may be able to get started with You may be able to get started with

institutional funds, but these may not get you institutional funds, but these may not get you very far.very far.

There are sources of support, but they must There are sources of support, but they must be stakeholders in what you want to be stakeholders in what you want to accomplish.accomplish.

You must be imaginative in thinking about You must be imaginative in thinking about stakeholders/fundersstakeholders/funders

You can fund for a targeted reason, but You can fund for a targeted reason, but expand to multi-purposes over timeexpand to multi-purposes over time

Support will expand as you expandSupport will expand as you expand