Clinical and Translational Science Awards (CTSA)
Anthony Hayward
October 30, 2007
Vision for the CTSA Program
Strengthen Clinical Research as an Strengthen Clinical Research as an academic discipline by creating a academic discipline by creating a ‘home’ and a career structure.‘home’ and a career structure.
Support the clinical and translational Support the clinical and translational researcher through provision of researcher through provision of resources that are most needed.resources that are most needed.
Speed clinical and translational Speed clinical and translational research through resource and data research through resource and data sharing.sharing.
Advance the safety and quality of Advance the safety and quality of research through adoption of good research through adoption of good clinical practices and effective use of clinical practices and effective use of informatics.informatics.
Trial Design
Advanced Degree-Granting
Programs
Participant& CommunityInvolvement
RegulatorySupport
Biostatistics
ClinicalResources
BiomedicalInformatics
ClinicalResearch
Ethics
CTSACTSAHOMEHOME
NIH & other government
agencies
Healthcare organizations
IndustryIndustry
Each academic health center will create a home for clinical and translational science
MT
WY
ID
WA
OR
NV
UT
CA
AZ
ND
SD
NE
CO
NM
TX
OK
KS
AR
LA
MO
IA
MN
WI
IL IN
KY
TN
MS AL GA
FL
SC
VAWV
OH
MI
NY
PA
MD
DE
NJ CTRI
MA
ME
VT
NH
AK
HI
Building a National CTSA Consortium
Since 2006Since 2007
Participating Institutions
The transformation process
• In 2005, 66 universities were associated with 78 GCRCs where 14,760 investigators had 9257 protocols: 3245 publications were reported
• By 2011 NCRR expenditure on clinical research infrastructure will rise to $500M from $333M.
• Infrastructure/training support increase by ~ 40%
• Transformation to integrated consortium
• GCRCs had Research Subject Advocates – CTSAs designate their own preferred individual.
Organization of CTSAs
• Include an institution that can award higher degrees in clinical research
• Include research education and career development activities
• Cooperative agreements ensure that awardees work together as a consortium
• CTSAs send representatives to steering committees and workgroups
Consortium Governance & Organization
Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf
CTSA Steering Committees and Workgroups
• Embody the expertise of the Consortium
• Provide a forum for dialogue with the NIH
• Identify needs, goals and priorities
• Serve as a platform to adopt common standards
• Have deliverables and timetables
Alternative IRB models workgroup
Created to:
• Identify conditions favorable for pilot projects to test alternative IRB models
• Share experience with regional reciprocity and common IRBs
• Promote common consent language
• Develop metrics and identify roadblocks
• Address IRB differences e.g., in pediatrics
CTSAWeb.org