Transcript CTSA - Research Resources

NIH CTSA Awards:
A Home for Clinical & Translational
Science
Clinical Research
Ethics
Biomedical
Informatics
Clinical
Resources
Regulatory
Support
CTSA
HOME
Advanced
Degree-Granting
Programs
Trial
Design
Participant
& Community
Involvement
Biostatistics
NIH CTSA Awards:
A Home for Clinical & Translational
Science
Background leading to CTSA
CTSA Organization
CTSA Cores
CTSA Implementation
Planning Translational
Sciences
Centers and Cores: UTMB
Planning Molecular Sciences Planning Structural Biology
Tropical Diseases
Sealy Center for Molecular Sciences
Planning Bioinformatics/
WRCEand
Proteomics/Genomics
NBL
Welch Center in Chemical Designation
Biology
IHII
Sealy Center for Aging
Sealy Center for Vaccine
WHO Center for Tropical Diseases
CTSA
Development
Sealy Center for Cancer
Planning Membrane
CTD/CLO
NIEHS Center
Protein Program
GRIP
(HHMI) Center for Biodefense and
Emerging Infectious Diseases
Sealy Center for Structural Biology
Proteomics Center
DARPA Program
Centers
1990
1992
1994
Protein
Chemistry
1996
Analytical
Ultracentrifugation
1998
2000
2002
2004
2006
Computational
Membrane Protein Lab
Biology
BSL4 Facility
Protein Purification
Molecular
Bioinformatics
Signal Transduction
Organic
Synthesis
Biology
Genomics Core
Future NMR
Proteomics/
Cell Biology
BSL3/4:
Mass Spectrometry
X-Ray
Histopathology
cryoEM
Drug
Design
Biophysics
Nanotech
Optical Imaging
Metabonomics
Macromolecular Assembly
Systems
Animal MRI
Animal Knockout
Biology
Virtual Patients
Cores/Programs
Centers/Institutes
Inst. Clinical & Translational Research
Center for Nanotechnology
Dell Pediatric
Inst. Human Immunity &
Sealy Center Molecular Medicine
Research Inst.
Infections
Inst. Computational
Engineering Sciences
Center Biomedical
Sealy Center Cancer
Welch Center Chemical
Engineering
Imaging Research
Biology
National
(UTMB and UTA)
Center
Biocontainment
Microelectronics Center
HHMI Membrane
Sealy Center Vaccine
Lab
Protein Program
Development
Sealy Center Structural Biology
Texas Advanced
Western Regional
IC2
Proteomics
Center
Computer Center
Center of
Sealy
Center
Aging
Excellence
TI-3D
Biodefense
Seek
Assess
Research
Cores
Team
Translational/Clinical
Development
Drug Design
Animal Knockout
Computational
Biology
Membrane Protein Lab
Protein
Molecular
Protein Purification
Chemistry Biology Signal Transduction
NMR
Organic Synthesis
BSL4 Facility
Histopathology
X-Ray
BSL3
cryoEM
Animal MRI
Nanotechnology
Analytical
Ultracentrifugation
Products
3T Human
MRI
Bioinformatics
Genomics Core
Proteomics/
Mass Spectrometry
Optical Imaging
Metabonomics
Systems Biology
Resource Leveraging
UTMB
UT AUSTIN
• Medical School
• TI-3D
• WRCE
• Natural Sciences
• Biodefense & EID Center • Pharmacy & Toxicology
• Sealy Centers Vaccine Dev.• National Center Bioterror
& Structural Biology
Countermeasures
• Galveston National Lab
• Medicinal Chemistry
• World Leader in
• School of Engineering
Biodefense & EID
• Business School
• Biomedical Engineering • Established Incubator,
• UTMB Austin Program
Business Accelerator
• TACC
Major Participants
School of Medicine
School of Nursing
School of Allied Health
Graduate School of Biomedical
Sciences
UTMB Hospitals & Clinics
UTMB Austin Regional Campus
UT-Houston CTSA
Seton Health Network
Brackenridge Hospital (Austin)
Dell Children’s Hospital (Austin)
School of Natural
Sciences
College of Pharmacy
School of Social Work
College of Engineering
LBJ School of Public
Policy
School of Law
College of Education
College of Liberal Arts
(Psychology)
Principles guiding our approach
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Focus on teams
Integrating training
Encouraging mentoring
Engaging underserved populations
Establishing proactive processes
Enhancing partnerships
Continuing evaluation
Integrating ethics
CTSA AIMS
1.
To transform the research environment at the University of Texas
Medical Branch (UTMB) & the University of Texas at Austin (UT
Austin) to maximally facilitate clinical and translational research
2.
To transform the training environment at UTMB & UT Austin to
produce the next generation of leaders in clinical & translational
science
3.
To partner with other CTSAs, in particular the recently funded UTHouston and MD Anderson CTSA in collaborative networks to
support and conduct clinical and translational research
4.
To design administrative processes to support research and
education to achieve Aims 1 and 2; and to implement, evaluate and
revise them and ultimately to disseminate successful processes to
other academic institutions.
Organization
President
UTMB
Provost
UT Austin
CTSA Director
(Goodwin)
Deputy Director
UTMB Galveston
(Goodwin)
Deputy Director
UTMB Austin
(Shomaker)
Core Leaders
Deputy Director
UT Austin
(Sage)
CTSA Organization
Administration (J. Goodwin, W. Sage & S. Shomaker)
Tracking and Evaluation (K. Ottenbacher & K. Wooten)
Research Education, Training and Career Development (K. Anderson & L.
Abraham)
Biomedical Informatics (B. Luxon & E. Marcotte)
Design Biostatistics and Database Management (D. Freeman & L. Meyers)
Community Engagement and Research (S. Shelton & M. Velasquez)
Coordinating (W. Calhoun & B. Iverson)
Pilot Projects (E. Volpi & K. Diller)
Novel Methodologies (D. Gorenstein & S. Stavchansky)
Multidisciplinary Team Support (C. Soto & R. Helmrich)
Translational Technologies (A. Brasier & J. McDevitt)
Drug Discovery (B. Iverson & S. Gilbertson)
Participant and Clinical Interaction Resources (D. Powell & T. Erlinger)
Research Ethics (H. Brody & J. Robertson)
Regulatory Knowledge & Support (L. Stanberry & W. Sage)
CTSA-wide Committees & Meetings
Organized by Administrative Core
Meetings
Attendees
Frequency
Length
Purpose
Steering Comm.
See Table 5
Weekly
60 min.
See Section 5.b.3.
External Advisory
Comm.
Ext. Ad. Comm. plus CTSA
members as needed
Twice yearly
One day in fall;
4 hours in
spring
Review of all
activities
Internal Advisory Comm.
See Table 6
Monthly
60 min
See Section 5.b.5
Investigators
governance meetings
All CTSA investigators,
trainees, & staff
Monthly
60 min.
Information on
activities, input on
directions.
Translational Research
meetings
All CTSA investigators,
trainees, & staff
Monthly
60 min.
Presentations of
research in progress
Seminar Series in
Translational Research
All CTSA investigators,
trainees, & staff, and
academic communities
Monthly
60 min.
Topics in
translational
research from basic
and clinical
perspective
Scientific Review
Committee
Members listed in Pilot
Projects Core
Six times
yearly at
CTSA
retreat
Variable
Evaluate and rank
proposals to PPC,
NMC, PCIR, and
Education Core
Catalysts for Innovation
Leadership Contract
Members listed in Novel
Methodologies Core
Six times
yearly at
CTSA
retreat
120 min.
Brainstorm/develop
ideas for
applications of novel
technologies
Tracking and Evaluation (K.
Ottenbacher & K. Wooten)
Aim 1. Provide standardized training in program evaluation
and assessment to all core leaders, faculty, trainees, and
staff;
Aim 2. Based on the training provided in Aim 1, implement a
consistent protocol for data collection, tracking and
assessment of outcomes across all cores and CTSA
components; and
Aim 3. Conduct a team evaluation of the UTMB and UT
Austin research infrastructure to identify fundamental
processes that require modification or change in order to
create an environment and culture supportive of
translational research teams.
Relationship of components of formative &
summative evaluation
Context
Implementation
Outcomes
Relationships
Quality
& Capacity
& Quantity
Effectiveness,
Magnitude &
Satisfaction
Logic Model
Influences
Activities
Outputs
Resources
Formative
Evaluation
What aspects or
situations shape
the ability to do the
proposed work
What was the
program intended
to accomplish in
what environment
Short-term
Outcomes
Mid-Term
Outcomes
Long-term
Outcomes
Summative
Evaluation
What is the
assessment of
what resulted from
the proposed
activities
What was learned
about the
outcomes and the
scope of project
impact
Research Education, Training and
Career Development
Aim 1. Employ a nationally acclaimed framework for constructive
learning
Aim 2. Reorganize current training programs so that all trainees are
placed in active multidisciplinary collaborative translational
research clusters.
Aim 3. Ensure all trainees are provided mentoring teams
Aim 4. Provide a novel educational pipeline mechanism by
establishing the Texas Academy of Healthcare Leadership for
select undergraduate students, expanding undergraduate
research opportunities, and expanding existing programs for
talented high school and minority students
Aim 5. Revise existing predoctoral, postdoctoral and faculty
development programs to increase the number of successful
clinical and translational investigators
Potentially Relevant Doctoral Programs at UT Austin
Aerospace Engineering
Anthropology
Biochemistry
Biological Sciences
Biomedical Engineering
Cell & Molecular Biology
Chemical Engineering
Chemistry
Civil Engineering
Communication Sciences &
Disorders
Computational & Applied
Mathematics
Computer Sciences
Curriculum & Instruction
Ecology, Evolution, & Behavior
Educational Psychology
Electrical & Computer Engineering
Electrical Engineering
Engineering Mechanics
Health Education
Human Development & Family
Sciences
Jurisprudence
Linguistics
Marine Science
Materials Science & Engineering
Mechanical Engineering
Microbiology
Molecular Biology
Neuroscience
Nutritional Sciences
Nursing Science
Pharmacy
Physical Education
Plant Biology
Psychology
Public Policy
Science
Science Education
Social Work
Special Education
Biomedical Informatics
Create a highly interconnected,
web-based data management
and analysis infrastructure
that facilitates interoperability in
a multidisciplinary, multi-team
clinical & translational
environment, regardless of
where members may be
physically located
Partnership with UT HSC Houston
and MD Anderson CC CTSA
Link EMRs with rEMRs
Design Biostatistics and Database
Management
1. Provide investigators &
trainees with
biostatisticians and
epidemiologists to
implement optimal
study designs based on
state-of-the-art
statistical methods
2. Develop and implement
new statistical and
mathematical modeling
techniques for clinical &
translational research
3. Provide web-based data
collection and study
tracking systems for
clinical studies
Initial meeting with Coordinating
Center
Grant Writing
Assignment of
Biostatistician & DB Programmer
Grant Awarded
1 Biostatistician: assist study
design, testable hypotheses
2 Database programmer: dev plan
for data collection (with BIC/BIC
work groups)
8 Biostatistician: assist with
obtaining sample, data forms
(EMR)
9 Database programmer: start
making database (BIC)
3 Power analysis and Sample Size
Determination
10 Biostatistician: assist in
database development
4 Write Statistical Analysis
section of grant
5 Submit Grant
6 Review Study Section critique
with investigator
7 Assist in revising grant
11 Biostatistician: statistical
analysis and MS preparation
12 Publish Results
13 Begin writing next grant
Community Engagement & Research
Aim 1: Establish Community Research
Coordinating Center (CRCC) as a
mechanism to represent community
interests, provide support to
researchers, and coordinate the use of
relevant community assets.
Aim 2: Develop, maintain, and coordinate
Practice-Based Research Network
(PBRN) of community health care
providers Aim 3: Provide education
and development in community-based
participatory research
Aim 4: Coordinate the community
advisement and communications
function for the CTSA
Aim 5: Engage voluntary health
organizations (VHO) in the CTSA
Aim 6: Develop and disseminate information
to public audiences, policy makers,
and community clinicians
Texas Clinical Networks
Coordinating Core
Aim 1. To provide ‘one-stop shopping’ for
investigators desiring to participate in CTSArelated research
Aim 2. To coordinate multidisciplinary Translational
Teams and Research clusters
Aim 3. To facilitate clinical and translational
research, by identifying project needs, allocating
resources, and monitoring progress
Aim 4. To increase throughput and efficiency of
translational research, by identifying and
overcoming rate-limiting resource barriers for
CTSA core activities, eliminating possible
duplication of effort
Core Interactions
Resource Core
Resource Core
Resource Core
Resource Core
Resource Core
Coordinating Core Coordinators
Tracking & Evaluation
Research Education & Training
Multidisciplinary Team Support
Aim 1. Provide administrative and mentoring support to
form new research clusters and help existing clusters
achieve stable external funding
Aim 2. Assist in creation, implementation, maintenance and
termination of Translational Teams
Aim 3. Conduct ongoing evaluation of the processes and
outcomes of Translational Teams
Aim 4. Conduct education and training in team processes
Multidisciplinary Team Support
Aim 4. Conduct education and training in team processes
Module Topic
Module Content
Effective Team Processes
Types of teams, Models of Team effectiveness, Team assessment
procedures, Team followership versus leadership, Stages of
development/evolution, Development of team culture and norms, Use
of Creativity
Meeting
Facilitation/Management
Developing agendas, Contextual and constituent planning,
Stakeholder analysis, Facilitation skills and techniques, Identifying
roles and tasks, Dealing with disruptive behavior, Time management,
Meeting techniques and procedures, Feedback and documentation.
Interpersonal Communication
Models of interpersonal communication, Models of effective
interpersonal communication, Non verbal communication, Styles of
communication, Influencing individuals, Influencing teams, Listening
skills, Communicating across genders, ethnic orientations, and
generational lines
Conflict
Resolution/Negotiation
Types of conflict, Origins and diagnosis of conflict cycles, Steps and
skills to reduce conflict, Negotiation planning, Negotiation strategies,
Managing strategic relationships
Project Management
Supervision, Legal and institutional considerations, Team
membership, setting goals, identifying resources
Funds to be awarded by Pilot Projects Core
# /yr
Amt
Term
$$ /yr
Deadline
Pilots awarded with CTSA and institutional funds
Research Grants
2-4
50-100 K
1-2 yr
200 K
August
Novel Technologies Awards
4-6
25-125 K
1-2 yr
400 K
December
Seed Money
10-15
5-30 K
2-12
mo
150 K
April, August,
December
Trainee Awards
8-15
5-30 K
1 yr
125 K
April, August,
December
Support for symposia
1-2
5-10 K
< 1 yr
15 K
April
10
0.5 K
1 mo
5K
April, August,
December
4
50 K
6 mo
200 K
April
2-4
50-100 K
1 yr
400 K
August
200 K
April, August,
December
Other support awarded with CTSA funds
Grantsmanship support
Other support awarded with institutional funds only
Translational research faculty leave
Bridging Grants
Support for CTSA resource utilization with CTSA and institutional funds
Analytical support
15-50
< 30 K
1 yr
Novel Methodologies
Aim 1. To create a “Catalysts for Innovation Leadership
Council”(CILC) to seek out promising early-stage
technologies
Aim 2. To sponsor new methodologies that accelerate
translational research and product development for
Pilot Project Core Funding.
–
New Core grants to develop novel cores or centers
•
–
1-3 yrs @ $50-125,000/yr
Enabling Technologies planning grants to lay the
foundation for Pilot Core grant or extramural grant
applications
•
1-2 yrs @ $25-50,000/yr
Aim 3. To build on UTMB and UT Austin's success in
developing academic-industry partnerships to
improve the product development pipeline for
translational research
Novel Methodologies: Enhanced
therapeutics pipeline
Yellow boxes =
possible new
NMC cores
Green = BIC, TTC
Gray = DDC &
other CTSA
cores
Translational Technologies
Aim 1. Adopt uniform processes in
study design, sample handling
and data processing.
Aim 2. Support high-throughput
genomics to identify disease
susceptibility and treatment
response.
Aim 3. Enable biomarker discovery in
proximal fluids of diseased
tissues.
Aim 4. Serve as a focal point for
training in the use of highthroughput post-genomic tools in
patient-oriented research.
Drug Discovery
Aim 1. Establish a coordinating infrastructure between
UTMB & UT Austin in synchrony with a newly
established administrative structure for the Texas
Institute for Drug and Diagnostics Development (TI3D)
Aim 2. Establish ‘cradle-to-clinic’ Drug Discovery
Research Teams (DDRTs) to move drugs from the
lab into the clinic & marketplace
Aim 3. Establish a High Throughput Screening Facility
(HTSF) to vastly increase investigators’ ability to
identify efficacious compounds for a given disease
state or model
Pathway of drug
discovery
processes
Figure 1
Participant & Clinical Interactions Resources
Aim 1. To transform clinical research at UTMB and UT Austin
by creating:
a.
Central, high intensity clinical research sites in
Galveston and Austin, including development of a CRC
in Austin
b.
A network of flexible collaborative disease-associated
clinical research sites in the AHCs
c. Low intensity research sites for community-based
investigations both in Galveston and Austin
Aim 2. To establish a participant recruitment resource to
provide subjects of all ages, genders and ethnicities for
clinical research
Aim 3. To develop and implement a sample preparation and
repository laboratory
Aim 4. To serve as a training facility for clinical research
education, and as a “home” for multidisciplinary research
support personnel
Research Ethics
Aim 1. Create a continuum of ethical best
practices across the life cycle of
translational research
Aim 2. Generate new knowledge by
conducting hypothesis-driven
research into emerging Clinical and
Translational Research Ethics
issues
Aim 3. Proactively engage the diverse
CTSA constituencies in a Bioethics
Community Dialogue Initiative
Regulatory Training & Support
Aim 1. To provide comprehensive, “user-friendly”
regulatory support services, including Intellectual
Property, to CTSA investigators and research
subjects
Aim 2. To provide both compliance training and
continuing education for investigators and the
research community about the relationship
between the regulatory environment & public
policy
Aim 3. To promote research and development of
better systems for regulatory management,
compliance, and education, including barriers to
local and national collaboration among
translational researchers
Next Steps
Implementation Phase: Pre-Funding
Institutional Leadership. Detailed and specific letters of participation from the chief
academic officers of UTMB and UT-Austin, relevant Deans, Center Directors, and
Department/Unit Chairs commit recourses, space, and personnel
Institute for Clinical and Translational Science
Mission: to promote and conduct innovative, interdisciplinary, translational
research including basic and clinical scientists as co-investigators
Director: James S. Goodwin M.D.
– created 9/1/06
– increased visibility & prestige
– ability to make faculty appointments
~ 3,600 sq. ft. of contiguous office, conference room, classroom and research
space has been designated in the 5th floor of the John Sealy Hospital next to
existing General Clinical Research Center (GCRC)
UTMB Austin Programs Dean
Sam Shomaker, MD, JD (appointed Fall 2006)
UT Austin Vice Provost for Health Affairs
William Sage, MD, JD (appointed Fall 2006)
NIH CTSA Awards:
A Home for Clinical & Translational
Science
Clinical Research
Ethics
Biomedical
Informatics
Clinical
Resources
Regulatory
Support
CTSA
HOME
Advanced
Degree-Granting
Programs
Trial
Design
Participant
& Community
Involvement
Biostatistics