Clinical and Translational Science Strategic Plan CSP

1
Clinical and Translational Science Strategic
Plan (CSP)

• Just ideas for discussion

2
Each academic health center will create a home
for clinical and translational science
NIH other government agencies
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
CTSA HOME
Industry
Participant Community Involvement
Clinical Resources
Biostatistics
Regulatory Support
Healthcare organizations
3
Key orientation for CSP

• What can the consortium accomplish as a
  unified/federated organization beyond the impact
  of the individual sites?

4
Key Components of a Strategic Plan

• Mission
• Vision
• Goals
• Tactics
• Manual of Operations (MOP)
• Communication plan
• Evaluation plan
• Budget and funding

5
Clinical and Translational Science Awards

• The Clinical and Translational Science Awards
  (CTSAs) is a consortium that is transforming how
  clinical and translational research is conducted,
  ultimately enabling researchers to provide new
  treatments more efficiently and quickly to
  patients.
• The consortium is designed to
• Encourage the development of new methods and
  approaches to clinical and translational research
  
• Improve training and mentoring to ensure that new
  investigators can navigate the increasingly
  complex research system
• Design new and improved clinical research
  informatics tools
• Assemble interdisciplinary teams that cover the
  complete spectrum of medical research
• Forge new partnerships with private and public
  health care organizations

6
Who Cares about the CTSA CSP?

• Primary Players CTSA PIs and NCRR
• Key Partners
• Consortium committees
• NIH Institutes
• Key constituents
• Institutional officials for CTSA recipients
• NIH leadership
• Faculty at CTSA recipients
• Rest of clinical and translational research world
• Congress, industry, professional societies and
  organizations, the public, the press

7
Consortium Oversight Committee (COCC)

• Responsible for driving the process of developing
  the CSP
• Discussing on weekly conference calls
• Organizing input/writing the plan
• Deciding when iterations are needed with partners
  and constituents
• Crafting penultimate version for approval by COCC

8
COCC Members

• COCC Co-Chairs (currently Berglund and Califf)
• NCRR leadership (currently Alving and Hayward)
• PI members
• NIH members

9
NCRR Role

• Provides ideas and concepts for CSP
• Discusses drafts of plan for iterative input
• Has input into all aspects
• Approves through COCC
• Iteratively deals with consonance of plan with
  funding availability and allowable mechanisms of
  funding

10
PI Role

• Provides ideas and concepts for CSP
• Discusses drafts of plan for iterative input
• Has input into all aspects,
• Approves through COCC
• Has key input into feasibility of implementation
  of vision given institutional opportunities and
  constraints
• Monitors and communicates need for updates
  through COCC

11
Consortium Committees

• Represented by Co-Chairs and PI liasons
• Asked for input to vision and mission statements
  early on
• Asked for ideas about key priorities and needs
  prior to consortium wide retreat
• Review and comment on product of retreat
• Review and comment on drafts of CSP

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NIH Institutes

• Represented by NIH appointed and PI liasons
• Asked for input to vision and mission statements
  early on
• Asked for ideas about key priorities and needs
  prior to consortium wide retreat
• Review and comment on product of retreat
• Review and comment on drafts of CSP

13
Thoughts on Key Constituents

• Institutional officials
• Existential issue of role of CTSA within
  institutions (transforming or on the shelf?)
• Need to get these folks involved
• NIH leadership
• How do we deal with likelihood of new
  administration?
• Importance of clear CTSA consensus on value
• Faculty
• We are challenged to assure that we are
  communicating effectively with our own faculty
• This is a chance to do it

14
Thoughts on Rest of World

• Congress, the press, the public
• Communication methods very similar for these 3
  elements
• Should they be involved and how?
• Professional organizations and professions
• Too many to count
• Should they be involved and how?
• Industry
• IT, devices, drugs, payers, providers, etc
• Prediction private money will be more important
  no matter who gets elected so rules of
  engagement will be critical

15
Process for Strategic Plan

• Use face to face meeting of COCC to begin
  discussion of mission, vision and goals
• Retreat of operations committee shortly after
  face to face meeting
• Ask each committee to come up with list of what
  it believes the consortium should be doing
• Big Bang CSP retreat of PIs and NCRR leaders
  with reps of other key constituents
• Work towards plan agreement within 2 cycles of
  face to face meetings
• Treat the CSP as a living document

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Impetus for the CTSA Program

• Implementing biomedical discoveries made in the
  last 10 years demands an evolution of clinical
  science.
• New prevention strategies and treatments must be
  developed, tested, and brought into medical
  practice more rapidly.
• CTSA awards will lower barriers between
  disciplines, and encourage creative, innovative
  approaches to solve complex medical problems.
• These clinical and translational science awards
  will catalyze change -- breaking silos, breaking
  barriers, and breaking conventions.

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Building a National CTSA Consortium
WA
ME
MT
ND
VT
MN
OR
NH
ID
WI
NY
MA
SD
WY
MI
RI
CT
NJ
IA
PA
NE
NV
OH
DE
IL
IN
UT
MD
CO
WV
VA
KS
MO
CA
KY
TN
AZ
OK
AR
SC
NM
GA
AL
MS
TX
LA
AK
FL
HI
Participating Institutions
Since 2006 Since 2007
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Building a National CTSA Consortium
FY06 Grantees Center for Clinical and
Translational ScienceThe Rockefeller University
Center for Clinical and Translational
SciencesUniversity of Texas Health Sciences
Center at Houston Clinical and Translational
Science CenterUniversity of California,
Davis Clinical and Translational Science
InstituteUniversity of Pittsburgh Clinical and
Translational Science Institute University of
California, San Francisco Clinical and
Translational Sciences InstituteUniversity of
Rochester School of Medicine and Dentistry Duke
Clinical and Translational Science InstituteDuke
University Institute for Translational Medicine
and TherapeuticsUniversity of Pennsylvania Irving
Institute for Clinical and Translational
Research Columbia University Mayo Center for
Translational Science ActivitiesMayo Clinic
Oregon Clinical and Translational Research
InstituteOregon Health and Science University
(partnering with Kaiser Permanente) Yale Center
for Clinical InvestigationYale University
FY07 Grantees Atlanta Clinical and Translational
Science Institute Emory University (partnering
with Morehouse College) CTSA at Case Western
UniversityCase Western University CTSA at
Washington University Washington University CTSA
at Weill Cornell Medical College Weill Cornell
Medical College (partnering with Hunter
College) Institute for Clinical and Translational
ResearchUniversity Of Wisconsin
Madison Institute for Clinical and Translational
Research Johns Hopkins Institute of
Translational Health Sciences University Of
Washington Michigan Institute of Clinical and
Health Research University Of Michigan At Ann
Arbor North Central Texas Clinical and
Translational Science Initiative University of
Texas Southwestern Medical Center -
Dallas University Of Chicago CTSAUniversity Of
Chicago Univ of Iowa's Inst for Clinical and
Translational Science University Of
Iowa Vanderbilt Institute for Clinical and
Translational Research Vanderbilt University
(partnering with Meharry Medical College)
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Consortium Governance Organization
Governance Manual available at http//ctsaweb.org/
Docs/CTSA_Governance_Manual.pdf
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CTSAWeb.org
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CTSA Publication Policy

• Initial Discussion

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CTSA Publication Policy

• Publications emanating from an individual CTSA
• With direct CTSA funding of personnel
• With infrastructure support
• CTSA associated

23
CTSA Publication Policy

• Publications reflecting opinions about CTSA

24
CTSA Publication Policy

• Publications reflecting official view of CTSA
  Consortium
• With NIH and PI participation
• With NIH, but not PI participation
• With PI, but not NIH participation