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