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Industry. Other. Community. Institutions. Partners. NIH CTSA Awards: A Home for Clinical & Translational Science. Advanced Degree-Granting Programs. Clinical Research Ethics. Trial Design. CTSA HOME. Biomedical Informatics. Clinical Resources. Participant & Community

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nih ctsa awards a home for clinical translational science

Industry

Other

Community

Institutions

Partners

NIH CTSA Awards: A Home for Clinical & Translational Science

Advanced

Degree-Granting

Programs

Clinical Research

Ethics

Trial

Design

CTSA

HOME

Biomedical

Informatics

Clinical

Resources

Participant

& Community

Involvement

Regulatory

Support

Biostatistics

nih ctsa awards a home for clinical translational science1
NIH CTSA Awards: A Home for Clinical & Translational Science

Background leading to CTSA

CTSA Organization

CTSA Cores

CTSA Implementation

centers and cores utmb

Planning Translational Sciences

Planning Molecular Sciences

Tropical Diseases

Planning Structural Biology

Planning Bioinformatics/

Proteomics/Genomics

WRCEand NBL Designation

IHII

CTSA

CTD/CLO

Sealy Center for Molecular Sciences

Welch Center in Chemical

Biology

Sealy Center for Aging

Centers

Sealy Center for Vaccine Development

WHO Center for Tropical Diseases

Sealy Center for Cancer

NIEHS Center

GRIP

Planning Membrane

Protein Program

(HHMI)

Center for Biodefense and Emerging Infectious Diseases

Sealy Center for Structural Biology

Proteomics Center

Centers and Cores: UTMB

DARPA Program

1992

1996

1998

2000

2002

1994

2004

2006

1990

Protein

Chemistry

Analytical

Ultracentrifugation

Computational

Biology

Membrane Protein Lab

BSL4 Facility

Protein Purification

Molecular

Biology

Bioinformatics

Genomics Core

Proteomics/

Mass Spectrometry

Drug Design

Optical Imaging

Organic Synthesis

Signal Transduction

NMR

X-Ray

Biophysics

Macromolecular Assembly

Animal MRI

Future -

BSL3/4:

cryoEM

Nanotech

Metabonomics

Systems

Biology

Virtual Patients

Cell Biology

Histopathology

Animal Knockout

Cores/Programs

slide4

Centers/Institutes

Inst. Clinical & Translational Research

Center for Nanotechnology

Dell Pediatric

Research Inst.

Inst. Human Immunity & Infections

Sealy Center Molecular Medicine

Inst. Computational

Engineering Sciences

Center Biomedical

Engineering

(UTMB and UTA)

Sealy Center Cancer

Welch Center Chemical

Biology

Imaging Research

Center

National

Biocontainment

Lab

Microelectronics Center

HHMI Membrane

Protein Program

Sealy Center Vaccine Development

Sealy Center Structural Biology

Texas Advanced

Computer Center

Western Regional Center of Excellence Biodefense

IC2

Proteomics Center

Sealy Center Aging

TI-3D

Seek

Assess

Team

Translational/Clinical

Research Development Products

Cores

Drug Design

Membrane Protein Lab

3T Human

MRI

Animal Knockout

Computational

Biology

Protein

Chemistry

Molecular

Biology

Protein Purification

Bioinformatics

GenomicsCore

Proteomics/

Mass Spectrometry

Optical Imaging

Metabonomics

Systems Biology

Signal Transduction

NMR

X-Ray

Animal MRI

Organic Synthesis

Histopathology

Nanotechnology

BSL3

cryoEM

BSL4 Facility

Analytical

Ultracentrifugation

resource leveraging
UTMB

Medical School

WRCE

Biodefense & EID Center

Sealy Centers Vaccine Dev. & Structural Biology

Galveston National Lab

World Leader in Biodefense & EID

Biomedical Engineering

UTMB Austin Program

UT AUSTIN

TI-3D

Natural Sciences

Pharmacy & Toxicology

National Center Bioterror Countermeasures

Medicinal Chemistry

School of Engineering

Business School

Established Incubator, Business Accelerator

TACC

Resource Leveraging
major participants
Major Participants

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)

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)

principles guiding our approach
Principles guiding our approach
  • Focus on teams
  • Integrating training
  • Encouraging mentoring
  • Engaging underserved populations
  • Establishing proactive processes
  • Enhancing partnerships
  • Continuing evaluation
  • Integrating ethics
ctsa aims
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 UT-Houston 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

Deputy Director

UTMB Galveston

(Goodwin)

Deputy Director

UTMB Austin

(Shomaker)

Deputy Director

UT Austin

(Sage)

Core Leaders

Organization

Provost

UT Austin

President

UTMB

CTSA Director

(Goodwin)

tracking and evaluation k ottenbacher k wooten
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

Relationships

& Capacity

Implementation

Quality

& Quantity

Outcomes

Effectiveness, Magnitude & Satisfaction

Logic Model

Influences

Activities

Outputs

Short-term

Outcomes

Mid-Term

Outcomes

Long-term

Outcomes

Resources

Formative Evaluation

Summative Evaluation

What aspects or situations shape the ability to do the proposed work

What was the program intended to accomplish in what environment

What is the assessment of what resulted from the proposed activities

What was learned about the outcomes and the scope of project impact

Relationship of components of formative & summative evaluation
research education training and career development
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

biomedical informatics
Biomedical Informatics

Create a highly interconnected, web-based data management and analysis infrastructurethat 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

Initial meeting with Coordinating Center

Assignment of Biostatistician & DB Programmer

Grant Writing

Grant Awarded

1 Biostatistician: assist study design, testable hypotheses

8 Biostatistician: assist with obtaining sample, data forms (EMR)

2 Database programmer: dev plan for data collection (with BIC/BIC work groups)

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

11 Biostatistician: statistical analysis and MS preparation

5 Submit Grant

12 Publish Results

6 Review Study Section critique with investigator

13 Begin writing next grant

7 Assist in revising grant

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

community engagement research
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
Coordinating Core

Aim 1. To provide ‘one-stop shopping’ for investigators desiring to participate in CTSA-related 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

Core Interactions

Coordinating Core Coordinators

Tracking & Evaluation

Research Education & Training

multidisciplinary team support
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 support1
Multidisciplinary Team Support

Aim 4. Conduct education and training in team processes

novel methodologies
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
Novel Methodologies: Enhanced therapeutics pipeline

Yellow boxes = possible new NMC cores

Green = BIC, TTC

Gray = DDC & other CTSA cores

translational technologies
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 high-throughput post-genomic tools in patient-oriented research.

drug discovery
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 (TI-3D)

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

participant clinical interactions resources
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
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
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

implementation phase pre funding
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 science2

Industry

Other

Community

Institutions

Partners

NIH CTSA Awards: A Home for Clinical & Translational Science

Advanced

Degree-Granting

Programs

Clinical Research

Ethics

Trial

Design

CTSA

HOME

Biomedical

Informatics

Clinical

Resources

Participant

& Community

Involvement

Regulatory

Support

Biostatistics