Columbia University Medical Center (Schools of Medicine, Public Health, Dental and Nursing) Facilities: 1135 beds Pediatrics: Children’s Hospital of New York with 200 beds Training: Full range of pediatric specialties with 60 residents, 63 fellows and 155 medical student rotating annually CTSA funding/year: K12 Program—2/8 Pilot Grant Award—2 /8 MS/POR—2/10 Irving Fellow—1 Irving Scholar—1 Imaging Pilot Award—1 Dedicated Research Staff—4
Goals: Training, interdisciplinary collaboration, Biostatistics and IT, Community based research Current Barriers: Insufficient trained personnel, shortage of statistical support, communications across multiple schools and departments, too few patients in particular areas Potential Solutions: Standardized training and certification of research staff Research Nurse/Coordinator—3 (ER, PICU, NICU) Multi-CTSA collaboration (NYC CTSAs) Expansion of Staff in Biostatistics and IT for courses and consultation Primary and Specialty Care Collaboration
Duke University Health System/ Duke Translational Medicine Institute CTSA PI: Robert M. Califf MD Chair of Pediatrics: Joseph W. St. Geme III MD Voting member: Jennifer S. Li MD MHS Facilities: 3 Hospitals with 1498 total/181 pediatric bed capacity; home care and hospice services; primary and specialty care clinics in communities throughout the region Pediatric department centralized at Duke Children's Hospital and Health Center , 158 faculty members, 19 comprehensive specialties Training: 73 residents, 55 subspecialty fellows, 101 students/yr on rotation; institutional and departmental K12 awards, T32 awards in the department and in pediatric cardiology, neonatology, A/I, heme-onc, rheumatology Research: 293 active protocols, 10 NIH sponsored pediatric networks, data coordinating center for 24 pediatric multi-center trials • Components: Duke Clinical Research Institute, Neonatal Perinatal Research Institute, Pediatric Site-Based Research Unit, Pediatric Genetics and Genomics Research Center. Pediatric Vaccine Unit, Pediatric Cell Therapy Unit, Quantitative Sciences, Community Research, Pediatric DCRU (phase 1 unit)
Goals: “ To enhance the health of children by fostering therapeutic discovery through collaborative translational and clinical research” • Expand the therapeutic breadth of Pediatric Phase 1 studies • Expand Community component • Develop Neurodevelopmental Outcomes Research Unit • Develop targeted cell therapies for inherited metabolic disorders, brain injuries, and type I diabetes • Expand FDA-DCRI collaboration for pediatric drug trial analyses Current Barriers: 1) achieving the proper balance between specific pediatric needs and integration of research within the overall institutional effort, 2) ensuring that efforts in health services research are complementary to the operations of the health system, 3) recruitment and retention of faculty (too few in the pipeline), 4) delays to intellectual property issues and contracting 5) $$$ Potential Solutions: develop academic and industry partnerships; coordinate local and intra-CTSA research programs; collaborative informatics, terminology, and operations
Facilities Mayo Eugenio Litta Children’s Hospital 90 beds (16 NICU, 30 PICU, 44 general care) Mayo Clinic T. Denny Sanford Pediatric Center comprehensive, multispecialty pediatric clinic Clinical Research Unit – inpatient, outpatient, & mobile units serving adults & children Training programs PhD, Masters Degree, & Certificate programs Research Basic, translational, & clinical research, with emphasis on cancer, aging, behavioral & developmental biology, immunology, CV & GI conditions, vaccinology & infectious diseases Mayo Clinic W. Charles Huskins, MD, MSc Mayo Eugenio Litta Children’s Hospital Mayo Clinic T. Denny Sanford Pediatric Center Robert M. Jacobson, MD
Goals Expand ranks of experienced translational investigators Enhance multidisciplinary translational research, particularly for musculoskeletal, gastrointestinal, & neurologic conditions Current barriers Small but growing cadre of pediatric investigators Small but growing community with limited diversity Community engagement programs just being initiated Potential solutions Enhance research education & training opportunities Collaborate in multicenter studies, particularly those involving conditions affecting children and adults Expand community engagement programs Mayo Clinic
Oregon Health & Science University (OHSU) Facilities: Doernbecher Children’s Hospital:151 beds OHSU Hospital: 373 beds. Also VA, Shriners Pediatric Department located at Doernbecher Children’s Hospital on main campus of OHSU connected to OHSU Hospital; 70 faculty Training: Nearly full range of pediatric specialties with fellowship training-24 fellows currently in training. Medical student training: 190 students per year on rotation and elective CTSA Research: CTRC: 22 pediatric protocols from 10 PI’s; many additional pediatric studies utilizing CTSA related services
Goals – Education & Training: Train a cadre of early career pediatric C/T researchers Translational research in metabolic disease/nutrition/genetics, endocrinology, oncology, renal; expand into cardiology, infectious disease, neuroscience. Expand on strong base in community research Current Barriers : Few senior mentors in C/T research, relatively small patient base in some areas, PI’s too busy trying to renew basic science grants to consider developing new C/T research collaborations Potential Solutions : enlist assistance of senior mentors from outside department, collaborate with other institutions in research subject recruitment, form teams of basic scientists and C/T researchers especially with internal funding opportunities to incentivize new C/T research collaborations
Rockefeller University Hospital, New York, NY First free-standing clinical research center, established 1901 Inpatient unit with 20 bed capacity + outpatient unit, both devoted solely to clinical research protocols Organized by individual labs rather than academic departments Training: CTSA Clinical Scholars Program grants Master’s in Clinical and Translational Science (16 scholars as of July 1, 2008) Research: 99 active protocols in the areas of HIV, dermatology, addiction, obesity, oncology, hematology, and immunology 11 protocols include volunteers under the age of 18 None of the active protocols are focused exclusively on children, although RU has a history of pediatric research in the past. Sandhya Vasan, M.D Voting Member
Goals : To expand the scope of current pediatric research To continue to improve training for new translational investigators Current Barriers : Small research hospital with no pediatric department Potential Solutions : Recruitment of new pediatric faculty (e.g., Jean-Laurent Casanova) Collaborative studies with other CTSA centers Active tracking and feedback on K12 Clinical Scholars Program
Improvement in “brokering” relationships between clinicians, “bench” scientists and industry and technology
Acceleration of multicenter and local clinical trials
Training of competent clinical research scientists for the future
Local and regional competition for, “town and gown” political problems
Fiscal crises: federal, state and local county
Faculty time and effort, P and T committee issues
Space limitations: labs, offices
Administrative barriers and red tape- internal and UC-wide:
Contracts, liability, Intellectual property rights
Partnering (Shriners. LLNL examples), web based dialogue
both internal and external
Local Symposia as showcase and forum for discussion
and exchange of ideas
Use of K30 program and K12 grants (2 currently In Pediatrics) coupled with CTSA funds to develop new clinical investigators, funds
for Peds Clinical coordinator
UCSF CTSI Pediatric Clinical Research Center UCSF, Children’s Hosp of Oakland, Kaiser Oakland, SFGH, Mount Zion PCRC Advisory Committee reviews all protocols Access through CTSA to Bioinformatics, Statistics, “SOS” pilot funds UCSF Independent PCRC for 30 years prior to CTSA, pioneer in pediatric HIV Currently a site of the UCSF CTSI CRC 5-bed inpatient unit with lead-lined room Outpatient unit and infusion center ICU research nursing team covering: Neonatal, Cardiac and Pediatric ICUs, Transitional and Well Baby nurseries, L&D, OR, Imaging & Radiology Specimen Processing Lab, shipping, EBV lines Neurodevelopmental psychologist, full time Nutritionist, DEXA, body composition & exercise testing Pediatric Research Pharmacy Poster printer
UCSF CTSI Pediatric Program Goals and Challenges
Integrate Research into the design of the new UCSF Children’s Hospital, currently planned to open 2012-2014.
Increase the pipeline of pediatric translational investigators.
Broaden the scope of research conducted in the PCRC.
Make funds and research coordinator support available for starting projects that will lead to competitive funding applications.
Participate in more multi-institutional studies, we hope by taking advantage of CTSA infrastructure.
J Puck, June 18, 2008
Children’s Hospital of Philadelphia University of Pennsylvania
430 bed free-standing hospital (CHOP) affiliated with University of Pennsylvania
Goals: Translational therapeutics; Bridging the pediatrics / adult divide; Education and investment in human capital
Barriers: Transforming culture; Uncertain funding climate; Lack of support for pilot studies
Solutions: Joint roles; Charge-back mechanism & institutional support; Pilot grants
Goals for POC: Establishing strong pediatric networks for research and advocacy
Research: - 76 active pediatric protocols, from 17 sub-specialties (PCTRC) - 13 active pediatric protocols, from 5 sub-specialties (PBRN) Training: Unified Fellows Course; 3 year program tailored to the professional development of fellows in the Department of Pediatrics. The overall goal is to assist fellows in making a successful transition from fellowship to early faculty positions as physician-scientists, clinical researchers and academic educators in their subspecialties.
University of Pittsburgh Clinical and Translational Science Institute
Participant and Clinical Interactions Resources Core (PCIR)
Pediatric Clinical and Translational Research Center (PCTRC)
Pediatric PittNet (Practice Based Research Network)
Goals : - Reduce barriers to investigators - Expand practice based research Current Barriers: - Regulatory, IRB issues- Parental concern about participation of children in clinical research Potential Solutions : - S. Arslanian (Dir. PCTRC), D. Perlmutter (Dept. Chair) and C. Ryan (IRB Chair) formed Advisory Committee to address local barriers- Participation in POC to address IRB barriers and facilitate pediatric research - A. Hoberman joined PCTRC, Advisory Committee and POC to provide expertise in practice based clinical research. Developed multicenter survey to assess factors that influence parents decisions to consent to research
University of Pittsburgh Clinical and Translational Science Institute
Participant and Clinical Interactions Resources Core (PCIR)
Pediatric Clinical and Translational Research Center (PCTRC)
Pediatric PittNet (Practice Based Research Network)
Department of Pediatrics, Rochester NY Clinical Facilities : - 2 hospitals, all pediatric subspecialty care centralized - 2 large primary care practices (40% of city children) - Incredible town-gown relationship Research - Major health services research program (50% of total) - Large programs in ID, neonatology, renal, neurology, heme-onc, others - Altogether > 100 protocols Teaching - 40 residents, 100 students, community pediatrics
Department of Pediatrics, Rochester NY Current CTSA Activities - Pediatric researchers involved in many of the 11 functions. - Pediatric faculty have leadership positions in: -Administrative Core -Community Engagement (Co-PI on PBRN, NIH suppl.) -Research Education and Career Development -Upstate Consortium Goals - More funding from CTSA programs - Improved centralized research office for studies (fieldwork) Barriers - IRB, IT for EMR for PBRN, Communications, Funding Solutions - Work collaboratively within CTSI
insufficient funding to support staff, junior investigators, ancillaries, or develop new programs
Can’t accept new protocols
Can’t support junior staff projects
NIH flat budget
Funding from philanthropy, industry, or medical center
Funding from NIH, foundations, or business community
Case Western Reserve University Pediatrics in the Clinical and Translational Science Collaborative Three hospitals with Pediatric Units (one a top-5 hospital) each has training program and fellowships in toto in 14 subspecialties, famous in neonatology and pulmonary Medical students rotate at all three hospital systems in Pediatrics Most popular specialty chosen by graduating seniors last year. Department with >$30M in external research support
CTSA Participation Effective competitor for K12 slots at all the institutions, plus more than 12 K awards outside CTSA - participate in “K community” Many K awardees cross disciplines Training component emphasizes K to R transition. Major CRU user at the site of largest inpatient usage – CF, sleep programs, PPRU site – One CRU located in Children’s Hospital CTSC plans to upgrade the Pediatric Practice Based Research Network as a new leader is recruited – was active under former leader
Clinical and Translational Research Program for Pediatrics (CTRPP) Atlanta, Georgia
Establish network of centrally organized pediatric clinical interaction sites , fostering integration and collaboration.
Encourage basic and clinical scientist interaction, enhancing discovery and clinical implementation , improving children's lives.
Build a robust centralized research infrastructure dedicated to pediatrics, including a dedicated Pediatric Clinical Trials Office.
Develop the Child Health Institute at MSM, incorporating research and collaborations with education, patient care, and advocacy, to build collaborative care for children with special healthcare needs .
Expand and enhance our training program in pediatric clinical and translational research and ensure researchers have the tools to become successful and independent .
Create a bidirectional process between the Clinical Interaction Sites and the Community Engagement program to disseminate pediatric clinical and translational research results
Accessing Nursing Research Alliance for qualified nurses
Sharing of resources with other programs to optimize efficiency
Facilities: Johns Hopkins Medical Institutions and the Kennedy Krieger Institute Johns Hopkins Childrens Center integrated within Johns Hopkins Hospital Training: Pediatrics internships, residency, subspecialty fellowships, T32 and K12 training programs Pediatric Clinical Research Unit consisting of 7 inpatient beds, outpatient clinic, procedures unit, infant lung function laboratory, mucociliary clearance laboratory, sleep laboratory Johns Hopkins Institute for Clinical and Translational Research---A CTSA program in Baltimore, MD
Goals: continue T-1 research; expand T-2 research including both community-based participatory research [CBPR] and practice-based participatory research [PBPR]
Current Barriers: unfunded mandates (our CTSA funding was cut administratively by 50%); inconsistent application of human subject protections across institutions; shortage of statistical support requiring outsourcing; need for external support for biobanking initiatives
Potential Solutions: Institutional support for pediatric clinical trials office to supplement university-wide clinical trials office; strong institutional support for community-based pilot projects and for biobanking initiatives; seeking outside funding to enrich statistical center as well as collaboration within the University (Health Studies)
University of Iowa CTSA Pediatrics Key Function - 1 Paired with the Genetics/Genomics Key Function Only Medical School in state, 70 Bed NICU, Numerous statewide pediatric programs (Perinatal, Birth Defects, Nursing etc) Four Aims 1. WIKI based interactions between pediatric faculty/staff/student (Donna D’Alessandro) 2. School nurse outreach to facilitate clinical trials in the community (Ann Marie McCarthy) 3. Perinatal health projects to integrate laboratory with clinical activities including NIH Neonatal Network (Jeff Murray/Ed Bell) 4. Biorepository of data/samples on pediatric in/outpatient population (Jeff Murray)
University of Iowa CTSA Pediatrics Key Function - 2 1. Goals - better internal/external communication; training of school nurses; expand existing biorepository (currently NICU only) 2. Barriers - buy in for use of Wiki’s; resources for school nurse training; capacity building for biorepository 3. Solutions - education, new hospital EMR implementation and work with Bioinformatic key function; partner with College of Nursing and grants for school nurses; working with genetics/genomics core, financial support from the hospital and College of Medicine to expand biorepository, partner with other CTSAs
Michigan Institute of Clinical and Health Research (MICHR)
MICHR CTSA : To provide infrastructure and tangible support to develop, help secure funding, and conduct high quality clinical and translational research projects that will positively affect patient care and outcomes
Pediatric Research Program (PRP): One of 12 programs within the MICHR CTSA
Pediatric Clinical Research Committee : Consultative committee of the PRP - currently consists of 17 faculty members with different specialties across divisions with the Department of Pediatrics and divisions with a pediatric focus in other Departments or Schools
To develop and support multidisciplinary clinical and translational research teams in pediatric populations
To contribute to the clinical research educational and mentoring mission of the UM CTSA
To serve as a central point of contact for investigators who seek to conduct biological, clinical, epidemiologic, or health services research with translational potential that involves children, adolescents, and/or their families
provide more “pediatric friendly” services for participants in ICTR studies
still in early stages of implementing ICTR plan
some pediatric investigators lack infrastructure for efficiently conducting studies and meeting participants’ needs
implementation of ICTR plan is in progress
some pediatric researchers hold leadership roles within the UW-ICTR and will advocate for pediatric studies and participants
Facilities: Three hospitals; Beds: 916: ; Pediatric CRC Pediatric department in stand-alone children’s hospital, as part of larger academic center Training: Full range of pediatric specialties with fellowship training; 74 fellows; K12 mentored career development Research: 26 laboratories; 52 active protocols in pediatric CRC Shari Barkin, MD, MSHS Kathryn Edwards, MD Monroe Carell Jr Children’s Hospital at Vanderbilt Vanderbilt Institute for Clinical and Translational Research
Vanderbilt Institute for Clinical and Translational Research
Goals: 1)Establish physical and virtual home for translational investigation; 2)Stimulate/streamline communications and remove impediments; 3)Develop a new generation of investigators; 4) Actively develop novel methodologies
Current Facilitators: Pilot funds available using the “Starbrite system”; Access to “studios” for assistance in hypothesis generation, methodology; statistical considerations, and translation.
Current Barriers: Lack of inpatient pediatric CRC
Potential Solutions: Use of adult CRC and scatter beds in the Children’s Hospital
(layer 2 page) Sub-menu based on researcher readiness/status
Institute of Clinical and Translational Science (ICTS) at WUMS Overall Components of ICTS at WUMS Washington University in St. Louis (WUMS) BJC Health System Barnes-Jewish Hospital (BJH) St. Louis Children’s Hospital (SLCH) Saint Louis University (SLU) School of Public Health College of Health Sciences (medical school) Graduate School St. Louis College of Pharmacy Southern Illinois University Edwardsville (SIUE) School of Nursing University of Missouri St. Louis (UMSL) College of Nursing Community health care organizations Biomedical companies in St. Louis area Pediatric Component concentrated at WUMS Department of Pediatrics & SLCH PORU (Patient Oriented Research Unit) PRU (Pediatric Research Unit; formerly GCRC) WUMS Pediatric & Adolescent Ambulatory Research Consortium (WUPAARC) Themes: DM, Asthma, SCD, CF, Brain Injury (neonatal & traumatic), Lung Injury
Pediatric Components of ICTS at WUMS 1. Interdisciplinary Career Development & Translational Research in Pediatrics - Aim 1: Increase number of pediatric fellows & junior faculty participating in Masters in Clinical Science Program (formerly K30). Barrier: Resources to attract fellows/faculty interested in clinical investigation –Aim 2: Increase number of investigators with focus on child-health clinical and translational research. Barrier: Low pool of established clinical/translational investigators - Aim 3: Create a Community Scientist Training and Research (C-STAR) program for pediatric residents. Barrier: Lack of time in residency program and ABP not receptive - Aim 4: Encourage research partnerships between pediatric advocacy organizations and pediatric investigators. Barrier: Lack of time in residency and fellowship training programs 2. Pediatric Research Unit (PRU) Formerly the pediatric GCRC; 11 th floor SLCH Part of the Center for Applied Research Services (CARS) at WUMS
Pediatric Components of ICTS at WUMS 1. Interdisciplinary Career Development & Translational Research in Pediatrics - Aim 1: Increase number of pediatric fellows & junior faculty participating in Masters in Clinical Science Program (formerly K30). Barrier: Resources to attract fellows/faculty interested in clinical investigation –Aim 2: Increase number of investigators with focus on child-health clinical and translational research. Barrier: Low pool of established clinical/translational investigators - Aim 3: Create a Community Scientist Training and Research (C-STAR) program for pediatric residents. Barrier: Lack of time in residency program and ABP not receptive - Aim 4: Encourage research partnerships between pediatric advocacy organizations and pediatric investigators. Barrier: Lack of time in residency and fellowship training programs 2. Pediatric Research Unit (PRU) Barrier: Under-funded & under-staffed Inadequate space
Clinical and Translational Science Center Pediatrics Oversight Committee Weill Cornell Medical College Julianne Imperato-McGinley, MD Principal Investigator / Program Director Patricia J. Giardina, MD Associate Core Director Clinical and Translational Resource Unit (CTRU) Donna DiMichele, MD Educational Ombudsman / Presenter June 23 – 24, 2008
Weill Cornell Medical College (WMC) Consortium Voting Member: Patricia J. Giardina, MD Facilities: 12 Partners Weill Cornell Medical College (WMC) * / The New York Presbyterian Hospital Memorial Sloan-Kettering Cancer Center (MSKCC) Hospital for Special Surgery (HSS) Hunter College Center for the Study of Gene Structure and Function & RCMI program Hunter College School of Nursing Cornell University Cooperative Extension Cornell-affiliated hospitals (6) located in underserved NYC communities * Pediatric Department: centralized at WMC Training: Full range of pediatric specialties with fellowship training - 41 fellows Medical Student Training - 100 students per year on rotation and elective - 30 visiting medical students per year Research: 90 eligible protocols ( 10 Pediatrics) Data coordinating center on site
WMC CTSC Goals Specific Barriers in Pediatrics Potential Solutions To provide education and multidisciplinary mentorship program for trainees and C/T researchers in partnering institutions Multi-disciplinary and diversity in level of training (pre-doctoral, post-doctoral, MD, PhD, DSN) Identification and recruitment of multidisciplinary mentors; Development of basic and specialized didactic core curriculum To foster innovative C/T research with partners in CTSC Navigating partnering institutions diverse policies, procedures and logistics Enhanced TRAC representation; Sharing of complimentary resources and the Translational Research Support Team (TREST); Regular conferencing To enhance new investigator C/T research Lack of funding and infrastructure support for new investigators / investigations TL1 Pre- and KL2 Post-Doc training awards and Pilot awards for new investigators; TREST Utilization To performing C/T research in multiple pediatric disciplines Too few patients in particular areas; Individual IRBs Shared complimentary resources and refined IRB process for multiple partners
Institute for Clinical & Translational Research Harry Shamoon MD, Associate Dean and CTSA PI Paul Marantz MD, MPH, Associate Dean Research Ed Brian Currie, MD, MPH, VP for Research, Ass’t Dean Frederick Kaskel MD, PhD, Vice-chair, Pediatrics, Site Co-Director, West Campus GCRC, Director Pediatric Nephrology CTSA direct links with “T1” Programs Human genetics and genomics – new chair Epigenetics – new Institute Proteomics – Expansion of core facility from GCRC base Stem cell research – new Institute and transplant program Biomarkers – new Diabetes Center director System biology – new department Training development programs: K30, 12, CRTP
Integrate C/T pediatric research resources across university. Participate in national pediatrics consortium efforts. Promote training and pilot grant programs to pediatric trainees to increase number and quality of pediatric C/T researchers. Publicize the CTSC resources. Integrate peds into the 10 main CTSC areas. Transformation to PCIR in concert with the other three GCRCs.
Very Large enterprise across Harvard community; “silos” within programs/hospitals. Modest incremental funding. Changes in ancillary support of GCRC model.
Avoid “old-think” about status quo at GCRC. Involve best and brightest C/T senior researchers in new training opportunities and expanded PCIR. Aim top candidates at training slots/pilot grants in CTSC. Establish pediatric metrics for participation in all levels of CTSC across the institution, and across all 10 areas of the CTSC project. Investigate means of covering “GCRC-like” ancillary costs for junior investigators.
1. Integrate all pediatric research and provide the necessary infrastructure to support new and established investigators.
2. Promote research regarding the pediatric antecedents of adult disorders.
Pediatric research competes for resources in the larger adult CSTA.
Inpatient beds for research are limited due to high occupancy rates.
Independent funding for pediatric CTSAs
Dedicated inpatient research unit
Nationwide Children’s Hospital The Ohio State University Department of Pediatrics Facilities: – Freestanding children’s hospital with 350 bed capacity, as well as two dedicated research buildings with more than 300,000 sq ft. contiguous with the main hospital. Training: – 33 fellowship training programs in pediatric specialties Research: Over 700 active IRB protocols: 52 managed in clinical research core (Clinical Research Services) others are managed departmentally.
Goals: Clinical research staff training programs that complement research efforts – assistance with study design, GCP to regulatory practice and quality assurance
Better/easier access to biostatistical resources
Offering specific focused resources for protection of human subjects for pediatrics and regulatory issues with gene transfer genomic analyses.
Current Barriers: collaborations between clinical and research faculty, providing statistical support across differential studies for grant and manuscript submission and lack necessary space as a result of continuous growth
Potential Solutions: Bench to Outcomes Seminar Series ( BOSS), research faculty attending clinical division meetings, revision of website to include project types for easily desired collaboration, continued work with OSU biostatistical program to include onsite service.
The Floating Hospital for Children at Tufts Medical Center, Tufts University School of Medicine Jonathan M. Davis, MD Chief of Newborn Medicine Program Director, Clinical and Translational Research Center
The Floating Hospital for Children at Tufts Medical Center
Facilities : Eight hospitals – 2,600 total licensed beds
Pediatric Departments at two teaching hospitals
Training : Full range of Pediatric Sub-specialties,
including medical and surgical; Fellows, Pediatric
Residents, and Medical Students routinely on rotation.
Research : Clinical and translational research; NIH
funded investigators in multiple areas of basic science
and clinical research; Pediatric Clinical Research Center
faculty working with investigators in the Institute for
Clinical Research and Health Policy; full statistical
The Floating Hospital for Children at Tufts Medical Center
Goals : Encourage young investigators to pursue careers in
academic medicine; support established investigators;
enhance multidisciplinary collaboration, generation of novel
research methods, academic innovation, and research education.
Current Barriers : Need to integrate research personnel and
subjects at multiple sites; too few patients in some areas; provide
investigators with sufficient time and support to conduct high
Potential Solutions : Provide support for all research related
activities (administrative, study coordinators, bionutrition,
laboratory, biostatistics); provide time and resources for new
Colorado Clinical and Translational Sciences Institute (CCTSI) Ronald J. Sokol MD, CCTSI Director Child and Maternal Health (CMH) Program
William Hay, Jr. MD, CMH Director (Co-Director, CCTSI)
Facilities: Brand new integrated Medical Campus plus 6 Hospitals including:
The Children’s Hospital, 270 beds – opened 2007
University of Colorado Hospital – NICU, maternal-fetal program, nursery
Denver Health - 44 pediatric beds
National Jewish Medical and Research Center
Kaiser Permanente Colorado
Training: Pediatric Residency (n=70), f ull range of pediatric specialties with fellowship training in all ( 9 Sub-Board Fellowships) with 6 T32 grants (n=70). Complete Department of OB-GYN with MFM, Repro-Endo, and Basic Research Divisions. Schools of Medicine, Nursing, Pharmacy, Dentistry, Public Health, Graduate, Allied Health, Education, Engineering, etc.
Research: $89 million sponsored funding for pediatric research, 2nd NIH ranked SOM Dept. of Pediatrics, CTRC (formerly GCRC in year 45), Clinical Trials Organization (TCH), Barbara Davis Type I Diabetes Center, Perinatal Research Center, over 700 active clinical research protocols, 108,000 sq. ft . of Lab Space, 22,000 sq. ft . Clin. Research Space
CMH Research Goals: Specific Aim 1: Develop a new, broad-based, multidisciplinary organizational structure to promote integration of Child and Maternal Health Clinical-Translational Research in the CCTSI. Scaffold for initiating new collaborations among basic, clinical, and translational scientists in multiple disciplines in both the medical center and the community. Specific Aim 2: Ensure the continuity of clinical-translational research from fetus to young adult by developing and incorporating infrastructure to assist investigators through all stages of research. Provide streamlined infrastructure for longitudinal, mother-child, multidisciplinary research programs. Specific Aim 3: Build on existing community resources to create new opportunities for community translational research in child and family health research and training. Provide a national model for transformation of current Pediatric and Adult General Clinical Research Centers. Managed by CMH Steering Committee including investigators from OB, neonatology, pediatrics, pediatric GCRC, behavioral and social sciences, bioengineering, Colorado Health Outcomes program, Medicine, Education, Nursing, Public Health, and Community programs . Current Barriers: Lack of a primary single clinical perinatal facility (OB/MFM only at UCH, Neonatology at both UCH and TCH); not enough ELBW/extremely preterm infants; competition with non-participating neonatology--OB/MFM services; not yet developed adequate nursing and community relationships; inefficient pediatric IRB review process Potential Solutions : Develop Maternal-Fetal-Neonatal Clinical Facility and Program at TCH. Increase School of Nursing (SON) investigators and community health program leaders in leadership roles in the MCH program; provide biomedical informatics support to communities, developing and enhancing direct communication; national CTSA collaboration for rare diseases, including neonates; data sharing needs to be developed; INFOED installed in Grants Office and IRB.
University of North Carolina at Chapel Hill Facilities: 5 Hospitals with 727 bed capacity Area Health Education Center (AHEC) provides state research environment UNC Pediatric Core encompasses intramural and extramural environments Training: Fellow, resident and medical student training programs Institutional K-12, K-30 and many T-32 training programs Research: GCRC/PCIR; Core Laboratories; Active protocols in university and community based settings David Peden
Goals - expand pediatric capabilities in PCIR - stepwise implementation of pediatric community engagement - multilevel training to build research and mentoring capability - integration of pediatric advocates in every CTSA endeavor Current Barriers - insufficient trained personnel; decentralized bioinformatics and statistical support; missed opportunities for enrollment and collaboration Potential Solutions – mentor development program; facilitate greater pediatric participation in K training programs; institutional effort for centralized bioinformatics; collaborate with other institutions progress
Bartter General Clinical Research Center Child Health Advocacy Research and Training (CHART) Center Christus Santa Rosa Children’s Hospital After CTSA Audie Murphy Veterans Administration Hospital Before CTSA
Facilities Adult Inpatient Unit - Bartter Clinical Research Unit Audie Murphy VA Hospital Adult Outpatient Unit – FIRST Outpatient Research Unit (off campus, free parking) Pediatric Unit - CHART Center at CHRISTUS Santa Rosa Children's Hospital 6,000 ft 2 outpatient facility, free parking, weekend hours, official hospital unit Regional Clinical Research Unit – Regional campuses and off site activities Training Short course (2 week) in clinical investigation (faculty, fellows, residents and staff) Masters of Clinical Investigation Program (faculty and fellows) 4 pediatric fellowship programs (2 more approved) Pediatric Research 10 protocols, 4 PIs (TODAY, HEALTHY, TrialNet, National Children Study) 5 protocols, 5 additional PIs (in process), >250 subjects Jannine Cody, PhD, Admin. Director Daniel Hale, MD, Medical Director