Download AIDS Clinical Trials Group - HIV Research Catalyst Forum

National Institute of Allergy
and Infectious Diseases
NIAID’s HIV/AIDS Clinical
Trials Networks & the
Community
Rona Siskind, M.H.S.
Division of AIDS, NIAID
April 21, 2010
DAIDS Scientific Approach
Division of AIDS (DAIDS)
Long-Range Priorities
Integration of prevention and treatment strategies
– Antivirals as prevention
Cure HIV infection
– Eradicate reservoirs
Re-cast the HIV/AIDS clinical trials networks
– Integration of HIV with significant co-infections
Division of AIDS
HIV/AIDS Scientific Priorities
Translational
Research /
Drug
Development
HIV
Vaccines
Mother to Child
Transmission
Microbicides
Prevention of
HIV
Infection
Optimization of
Clinical
Management
including
Co-Morbidities
Populations
DAIDS-funded HIV/AIDS
Clinical Trials Networks
 AIDS Clinical Trials Group (ACTG)
 International Maternal Pediatric Adolescent AIDS
Clinical Trials Group (IMPAACT)
 International Network for Strategic Initiatives in
Global HIV Trials (INSIGHT)
DAIDS-funded HIV/AIDS
Clinical Trials Networks
 Microbicide Trials Network (MTN)
 HIV Prevention Trials Network (HPTN)
 HIV Vaccine Trials Network (HVTN)
Layers of Community
Education/Outreach
National Strategies
Community
Partners
NetworkLevel CABs
Site-Level
CABs
NIAID/DAIDS & Partner
NIH Institute and Centers
Strategic Working Group
Leadership Groups for HIV/AIDS
Clinical Trials Networks
Global Community Advisory Boards
Units for HIV/AIDS
Clinical Trials Networks
Site Community Advisory Boards
Evaluation Plan
Community Partners
Clinical Research Mgmt Support
Contract
Network Leaders
Community Partners
 Goal:
 Define, harmonize & improve the role of community in the
research process
 Assist leadership as they seek community input & engagement
 Foster a stronger partnership
 Specific Objectives:
– Facilitate information exchange between community and Network/
DAIDS leadership
– Enhance inter-network community communication
– Identify and develop programs to meet the CAB needs, e.g.,
training
– Identify and address challenges to participation in clinical trials
Community Partners Activities
 Development of Recommendations for
Community Involvement
 Training Programs:
– Understanding the Clinical Research Process
– The Role of a CAB
 Working Groups:
– Site funding of CAB activities
– Site evaluation of CAB activities
– Scientific priorities
Network Recompetition 2013
Why?
 Networks funded for 7 years –
What do we hope to gain?
 Align our clinical research activities to
address the rapidly evolving scientific
questions of HIV+ and at risk populations
 Establish multi-disease research capacity
by capitalizing on infrastructure of the
HIV/AIDS clinical trials networks
 Build in flexibility
Assumptions




Don’t re-compete it all at once
Don’t fix what isn’t broken (avoid seismic changes)
Expand disease mandate (e.g., TB, hepatitis)
Free sites to work with more than one leadership
group
 Support for sites’ clinical activity
 Continued community involvement in the research
endeavor
Process for Developing NIAID
Request for Applications
Summer 2011
Winter 2010
Consultations
NIAID Staff,
Stakeholder
Groups
Additional
Consultations
for Feedback
Stakeholder Groups
Writing the
RFA
Spring/Fall 2013
Competition
Providing Input
 Individual Network meetings
 Electronic mechanism for broad
stakeholder comments
 “Town Hall” Meeting(s) – dates to be
determined
 Stakeholder consultations
Questions???