fred gordin chief, infectious diseases veterans affairs medical center; washington dc professor of...
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Fred Gordin
Chief, Infectious DiseasesVeterans Affairs Medical Center; Washington DC
Professor of Medicine; The George Washington University
[email protected]: (202) 745-8301
Total funding to Leadership Groups and Clinical Trials Units $270-$300 million yearly.
Grant duration – 7 years
2006 NIH Recompetitionof All DAIDS Networks
TranslationalResearch /
DrugDevelopment
Mother to ChildTransmission
Microbicides
HIVVaccines
Prevention ofHIV
Infection
Optimization ofClinical
Managementincluding
Co-Morbidities
DAIDS Priority Research Areasfor Leadership Groups
INSIGHT Network Structure
ArgentinaAustraliaChileIsraelJapanNew ZealandThailand
BrazilCanadaPeruSouth AfricaUnited States
AustriaBelgiumDenmarkEstoniaFinlandGermanyLithuaniaLuxembourgNorwaySwedenPolandPortugalRomaniaRussiaSpainSweden
France
Greece
Ireland
Italy
Morocco
Netherlands
Switzerland
United Kingdom
WashingtonICC*
SydneyICC
CopenhagenICC
LondonICC
Minnesota Coordinting Center
INSIGHT Executive Committee
*Based at VAMC
INSIGHT Science Agenda
Strategy Trials – studies designed to have
a broad impact on HIV care
Examples:
– Studies of IL-2 as antiretroviral sparing
– Studies of “What-to Start”
– Study of “When-to Start” HIV treatment– Vaccines to prevent complications of HIV
NIH-DAIDS invited applications from CTUs to conduct clinical research
CTUs could apply and indicate affiliation with one or more Networks
The CPCRA (Community Programs for Clinical Research on AIDS) CTU affiliated both with INSIGHT (137 sites) and with HPTN (18 sites)
Clinical Trials Units (CTUs)
CPCRA CTU Structure - 1
The proposed CPCRA CTU:23 Site Coordinating Centers , 137 Clinical Research Sites
Brazil, Rio
SCC 6
Brazil, Sao Paulo 7
CanadaSCC 14
PeruSCC 2
South AfricaSCC 1
US BronxSCC 4
US ChicagoSCC 5
US CORNETSCC 6
US DenverSCC 10
US FloridaSCC 4
US HarlemSCC 6
US Henr FordSCC 3
US HoustonSCC 5
US Los AngSCC 4
US LouisianaSCC 7
US New EngSCC 6
US No. JerseySCC 7
US PortlandSCC 7
US RichmondSCC 10
US San FranSCC 9
US So. JerseySCC 6
US Wash’tonSCC 6
US Wayne StaSCC 2
SCC n
CPCRA application:3642 pages15 inches38 pounds
CPCRA Clinical Trial Unit Funding - 1
CPCRA Unit Scored 176 (top third of approx 120 CTU applications)
CTU awards discussed at September Council meeting with awards by Dec 2006 (or later)
No discussions with NIH yet on specifics
CPCRA Clinical Trial Unit Funding - 2
Grant duration 5-7 years
First year funding likely $15-20 million CTU supplemental awards for new
research studies will be approved by the NIH.
When new research studies are approved, sites to do them will also be approved.
CPCRA CTU
GWU will be the grant recipient
GWU will fund multiple (>25) subcontracts
Subcontracts will go to
– Site coordinating centers (SCCs)
– Contract group to assist with: Web, data management,
meeting planning, travel
– Executive office at Washington VA