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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 • • • • • • • • 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