Transcript Clinical HIV Cohort: Lessons Learned (and Lessons Still to

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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To identify potential stakeholders, it is
important to consider to whom the research
questions matter.
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.

Stakeholders

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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.
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.

Examples of Registry Funding
(Rare Disease)
Description
Gaucher disease
Cystic Fibrosis
Fabrey disease
Funder
Genzyme
Genentech
Shire HGT
Type
Comm
Comm
Comm
Dates
19911993-2005
2001-
Purpose
Rare Disease
Multipurpose
Enzyme
replacement
therapy
outcomes
Examples of Registry Funding
(Birth Defects)
Description
Funder
Type
Bupropion in
GSK
Comm
Pregnancy
ART in Pregnancy Abbott,
Comm
Boehringer
Ingelheim , BMS,
Gilead, GSK,
Merck, Pfizer,
Roche Tibotec,
Novartis
Ribivirin in
Hoffman-La
Comm
Pregancy
Roche, Sandoz,
Shering-Plough
Dates
Purpose
1997-2007 Birth defects
1989-
Birth defects
2003-
Birth defects
Examples of Registry Funding
(Common Diseases)
Description
Follicular
Lymphoma
BPH
Early evaluation of
diabetes
Childhood asthma
Funder
Genentech
Type
C
Dates
2004-
Sanofi-Aventis
Astra-Zeneca
C
C
2004-2007 Quality of Care
2004Quality of Care,
Outcomes
2003Quality of care
and outcomes
2007Emerging ID
PHO (Cincinnati) HMO
Avian Flu
Purpose
Multipurpose
HoffmanLaRoche
HIV/AIDS (CNICS) NIH
HIV/AIDS
Ministries of
(EuroSIDA)
Health, Pharma
C
Govt
Govt
Com
20072000-
Outcomes
Outcomes
Coronary Stenting
Comm
2004-2006
Emboli protection
Cordis
Examples of Registry Funding
(Specific Treatments)
Description
Erythropoiesisstimulating
therapies
Palivizumab
Outcomes
Total Joint
Replacement
AZT for HIV
Funder
Ortho-Biotech
Type
Comm
Dates
Purpose
2003-2009 Outcomes in
oncology
Medimmune
Comm
Kaiser
Heatlh
Plan
Comm
2000-2004 RSV treatment in
children
2001Safety and
Quality
1987-1991 Safety
BurroughsWellcome
Examples of Registry Funding
(Multi-Disease)
Description
Maine Health
Clinical
Improvements
Registry
AE Spontaneous
event reporting
system
GPD (England)
Funder
Type
MaineHealth
Heath
and Maine Med. Plan
Ctr.
Dates
2003
Purpose
Multipurpose
for primary care
in opt setting
BW Hospital,
Health
Partner’s Heath Plan
2008-
Drug AEs
Ministry of
Health
2000-
Quality of Care,
Safety,
Outcomes
Govt
Examples of Registry Funding
(Multi-Disease)
Description
Funder
Group Health
GHP
Cooperative (WA)
Type
Health
Plan
Dates
1990-
Purpose
Quality of care,
safety,
Outcomes
Qualtiy of care,
safety,
Outcomes
Safety,
Outcomes
KaiserKP
Permanente (CA)
Health
Plan
1990-
Medicaid
(COMPASS)
FDA, CMS,
Pharma
Govt
Com
1985-
Saskatchewan
Ministry of
Health
Govt
1980-
Safety,
Outcomes
AE Spontaneous
event reporting
system
BW Hospital,
Health
Partner’s Heath Plan
2008-
Drug AEs
Funding
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Commercial
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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
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Funding

Foundation
 Targeted
 Short(er)
term
 Less support available
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Government
Federal
 State
 Local
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HIV/AIDS Registry
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Over 31,000 living PLWA/PLWH in
Maryland 2009

62% of these in Central MD
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32 per 100,000 in Baltimore (5th of urban
centers
Johns Hopkins AIDS Service
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Locations
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Johns Hopkins Hospital
Greenspring Station
Maryland County Health Departments
911 Broadway
Care

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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
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
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Johns Hopkins HIV Clinical Cohort
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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.
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 (20002005)
 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
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
Johns Hopkins HIV Clinical Cohort
(in 2010)
ACASI:
ARV Adherence,
Smoking, Alcohol,
Substance Use
QOL,
Depression
Medical Records
Abstraction:
Johns Hopkins,
Outside Facilities
Data Abstractors
Electronic Patient Data:
Laboratory,
Radiology,
Pathology,
Microbiology,
Pharmacy,
Hospitalizations
Vital Statistics:
Data Entry
Maryland,
NDI,
Social Security
JHHCC
Sample Size: 6,800
Publications: > 300
Person-Time: 65,000 PY Support: > $5,000,000 (annual)
NA-ACCORD
HIVRN
CNICS
IeDEA
Summary
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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