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  • PCTRC (Pediatric Clinical and Translational Research Center) PCTRC (Pediatric Clinical and Translational Research Center)
  • PCTRC (Pediatric Clinical and Translational Research Center) PCTRC (Pediatric Clinical and Translational Research Center)
  • Leadership in research endeavors related to heart, lung, and blood disease and sleep disorders. 95 million in peds, plus demonstration and education programs Examples include…
  • Transcript

    • 1. Pediatrics Oversight Committee CTSA Informal Introductions Bethesda, Maryland June 23, 2008
    • 2. 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
    • 3. 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
    • 4. 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) 
    • 5. 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
    • 6. 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
    • 7. 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
    • 8. 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
    • 9. 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
    • 10. 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
    • 11. 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
    • 12. Anthony Philipps, M.D .
      • University of California, Davis Medical Center
      • One of 5 UC Schools of Medicine
      • Location: Sacramento State Capital; Davis campus 20 miles w.
      • Facilities : 600 bed acute care hospital, level I Peds Trauma
        • Children’s Hospital (Hospital within hosp ) 120 beds
        • Dept Pediatrics integral part of Med Center: 90 faculty
        • Other academic Depts in support (Radiol, Anesth, Surg, etc)
        • Shriners Hospital (multidisciplinary) on campus and active collaborator
      • Training : medical students, Pediatric residency program, residents from FP,
      • Travis AFB and 5 fellowship programs
      • Research :
        • Research labs and clin programs >100 active protocols
          • some clin themes incl Frag X, Ca, Autism, Ethics, Diabetes, Vaccines
        • Wet labs with themes Obesity, Asthma, Renal, Nutrition, Genetics
        • Stem Cell/Cancer, Infect Dis.
        • UCD campus collaborators: Primate Ctr, Vet and Agric Schools, Ctr Health and Tech (Telehealth), MIND Inst, and others
    • 13.
      • Goals
        • 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
      • Current Barriers
        • 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
          • IRB
      • Solutions
        • 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
    • 14. 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
    • 15. 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
    • 16. Children’s Hospital of Philadelphia University of Pennsylvania
      • 430 bed free-standing hospital (CHOP) affiliated with University of Pennsylvania
      • Developed by merging 2 GCRC’s
      • $129,708,000 of extramural funding in FY 07
      • 180 current pediatric CTSA protocols
      • 21 pediatric divisions / departments
    • 17.
      • 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
    • 18. 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)
    • 19. 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)
    • 20. 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
    • 21. 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
    • 22.  
    • 23.
      • Goals
        • Advance basic, translational, and clinical science for children
      • Barriers
        • Competing priorities, awareness, researcher “pipeline”, absence of industry partners, ethical concerns, small sample size
      • Solutions
        • Skills development programs, pediatric research infrastructure, leveraging resources, collaboration across NIH Institutes, CTSAs
    • 24. Oakland Children’s Hospital (UCSF)
      • Facilities:
        • Two outpatient units
        • 240 inpatient beds; Day Hospital
        • Pharmacy/processing laboratory
        • SQUID,DEXA,Nutrition Cart
        • Diverse patient population, Sub-specialty programs, 5 fellowships and 75 residents
        • T32 and K training programs
        • University affiliations: UCSF, UC Berkeley, UC Davis
        • Extensive genomic, biochemistry, cell biology laboratory resources
        • Focus on translational research and training
        • School based programs
      • Research
        • Seven “Centers of Excellence”
        • Ranked #5 Nationally in NIH funds in 2007
        • 400 clinical protocols, 40 in CRC:hemoglobinopathies, oncology, diabetes, obesity, asthma,nutrition, genomics, birth defects, cystic fibrosis neurodevelopment, cord blood cardiovascular, alcohol and substance abuse
        • Active participant and leader in NIH clinical trail networks and industry studies
        • Pediatric and adult studies
        • Community oriented programs
        • Minority internships
    • 25. Oakland Children’s Hospital (UCSF)
      • Goals
        • Increase translational research projects
        • Support development of junior faculty
        • Increase training activities
        • Increase collaborations with other CTSA programs
        • Expand community engagement programs
        • Expand minority recruitment activities
        • Increase participation in NIH multicenter trials
        • Continue SEPA programs
        • Develop community based programs
      • Barriers
        • 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
        • Future projections
      • Potential Solutions
        • Funding from philanthropy, industry, or medical center
        • Funding from NIH, foundations, or business community
    • 26. 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
    • 27. 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
    • 28. Clinical and Translational Research Program for Pediatrics (CTRPP) Atlanta, Georgia
      • Emory University - Dept of Pediatrics
      • Morehouse School of Medicine (MSM) –
      • Dept of Pediatrics
      • Children’s Healthcare of Atlanta (CHOA)
      • Georgia Institute of Technology
    • 29. Pediatric Clinical Interaction Sites
    • 30.
      • Facilities
        • 452 staffed beds in three hospitals
        • 23 satellite locations around metro Atlanta
        • 5 immediate care centers
        • 2 primary care centers
        • 30 pediatric specialties
        • 493,00 patient visits
        • 227,000 unique patients
        • 128,000 inpatient days
        • 5,800 outpatient days
        • 34,200 surgical procedures (in-patient and out-patient)
        • 123,000 ED visits
        • 117,000 Immediate care center visits
        • 61,400  Primary Care Visits
    • 31.
      • over 700 protocols
      • 14 protocols using adult GCRC
      • Building centralized inpt/outpt research unit at Egleston
      • Centralized research department at CHOA
      • Centralized lab at Egleston supporting studies
      • Research pharmacist (1.0 FTE)
      Research
    • 32.
      • 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
      Goals
    • 33.
      • Staffing research unit/hiring of qualified research nurses
      • Multiple sites/geography
      • Multiple IRBs (Emory/CHOA/Grady)
      • Total research staff (IRB/grants/contracts)
      • Electronic data/databases
      • Working to integrate 2 separate research infrastructures at CHOA/Emory
      Barriers
    • 34.
      • Funding support from other sources
      • Accessing Nursing Research Alliance for qualified nurses
      • Sharing of resources with other programs to optimize efficiency
      • Community engagement
      Solutions
    • 35. 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
    • 36.
      • GOAL
      • 1) Enhancing communication across the multiple programs in the ICTR
      • 2) Finding best ways to leverage research infrastructure
        • a. Relationships with various schools
        • b. Relationships with cancer center
      • 3) Creating an academic home for translational researchers without a single physical location
      • 4) Measuring output or translational research successes
      • 5) Identifying most productive approaches to working with other academic institutions within CTSA
      • CHALLENGE
      • Having the discipline to evaluate programs and reallocate resources
      • WE OFFER
      • 1) Basic science and clinical translational forums
      • 2) Translational Research Navigator Program
      • 3) Advanced Translation Incubator Program (ATIP)
      • 4) Community Engagement Office
      • 5) Proteomics, Genetics, and Imaging Cores
      • AND MUCH MORE………..
    • 37. University of Chicago
      • Facilities: 2 hospitals (Comer Children’s and LaRabida Children’s Hospitals)
      • with 200 beds combined
      • Training: 54 peds-, 16 med/peds-, and 3 chief-residents; 42 accredited fellowship positions in 9 subspecialties and 2 positions in pediatric surgery
      • Research
        • Laboratory-based research with emphasis on translational applications. For example,
          • Sue Cohn and her work on angiogenesis in cancer
          • Bob Daum and his work on MRSA
          • Mike Moskowitz and his work on the genetic basis of congenital heart disease
          • John Cunningham and his work on new therapies for sickle cell disease
        • Therapeutic clinical trials. For example,
          • Participation in the Children’s Oncology Group
          • Ken Alexander and his work in HPV
          • Mike Schreiber and his work on nitrous oxygen
        • Health services research (ethics and outcomes)
          • Becky Lipton and her epidemiological work on diabetes
          • Alyna Chien and pay-for-performance health services research
          • Lainie Ross on expanding newborn screening
        • Resources:
          • New lab space to open in the Knapp Center for Biomedical Discovery
          • Establishment of Pediatric Clinical Trials Office (1/07)
          • MacLean Center for Clinical Medical Ethics with expertise in research ethics
        • 255 active IRB approved protocols in Dept of Pediatrics
    • 38. University of Chicago
      • Research
        • 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)
    • 39. 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)
    • 40. 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
    • 41. 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
    • 42.
      • 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
      Pediatric Research Program within MICHR
    • 43.
      • UT Southwestern Medical Center at Dallas
      • 7 affiliated hospitals (3 pediatrics-only facilities; 2000 beds)
      • Pediatric hospitals
        • Children’s Medical Center Dallas (411 beds) – teaching
        • Parkland Memorial Hospital (810 beds) – teaching
        • Texas Scottish Rite Hospital for Children (100 beds) – teaching
        • Children’s Medical Center Legacy (72 beds) – non-teaching
      • Training
        • 230 medical students per year
        • 87 pediatric residents per year
        • 19 pediatric residencies or fellowships
      • Pediatric clinical and translational research
        • Main players: Hematology-Oncology, Infectious Disease, Psychiatry, Urology
        • Clinical research department at CMC Dallas
        • New Department of Clinical Sciences at the University
      Charles Quinn, MD, MS
    • 44.
      • Goals
        • Advance the standing of clinical research at the university
        • Improve the quality and quantity or pediatric research at the university
        • Train investigators in clinical sciences
        • Develop an interactive community of clinical investigators
      • Current Barriers
        • History and pre-eminence of basic science research
        • Small, scattered community of clinical investigators
        • Lack of integration between the CTSA/University and Children’s
      • Potential Solutions
        • KL2/K12 Clinical Research Scholars’ Program (12/39 scholars are pediatricians)
        • Integrate the adult and pediatric research infrastructure where appropriate
        • Increase pediatric funding opportunities
        • Regular multi-disciplinary meetings of pediatric clinical researchers
        • Good ideas from this meeting
    • 45.
      • Successes of Pediatric Program in Year 1 of UW CTSA
        • Pediatrics well-integrated into leadership including PCRC, Regulatory Support, Bioethics, Informatics and Novel Methods
        • Center for Clinical and Translational Research established at Seattle Children’s Hospital as link between institution and CTSA
        • Creating common practices between Children’s and UW – CRC functions, billing guidelines, common application and IRB reciprocity
        • CTSA Pilot Program and Mentored Scholars Program for investigators focusing on childhood disorders launched May 2008 (institutional support from SCHRI)
      Seattle Children’s Hospital Research Institute (SCHRI)
      • Site of University of Washington CTSA pediatric program – Bonnie Ramsey, Co-PI
      • $31 million in research funding
      • Over 400,000 ft 2 of research space
      • 190 Investigators
      • Growth
        • 80,000 ft 2 under construction now
        • Building 2 complete in 3-5 years adding over
        • 500,000 ft 2 to the campus
        • Growth potential to 2 million ft 2
    • 46.
      • Goal
      • Training – implement Mentored Scholars Program (4 scholars chosen) for
      • pre-K early faculty
      • Research support – implement CTSA Pediatric Biomedical Informatics and
      • Statistics core in Fall 2008; recruit senior biostatistical faculty
      • Implement cost sharing program for PCRC
      • Current barriers
      • Delays in contract negotiations
      • Data management support
      • Inability for research support staff to move across UW affiliated institutions
      • Potential solutions
      • Utilize Toyota LEAN process to optimize contract negotiations across UW
      • CTSA institutions
      • Establish common training/certification of research staff across UW
      • institutions
      UW/SCHRI Partnership for CTSA
    • 47.
      • University of Wisconsin-Madison
      • American Family Children’s Hospital: 60 bed facility opened August 2007
      • Adult and VA hospitals on same campus (UW-Madison main campus)
      • Pediatric department centralized at teaching hospital
      • Full range of pediatric specialties
      • 39 pediatric residents, 15 sub-specialty fellows
      • Institutional and cooperative group clinical research (Children’s Oncology Group, Childhood Asthma Research and Education)
    • 48.
      • Goals :
        • streamline IRB/CTRC review process
        • coordinate ICTR resources
        • provide more “pediatric friendly” services for participants in ICTR studies
      • Barriers :
        • still in early stages of implementing ICTR plan
        • some pediatric investigators lack infrastructure for efficiently conducting studies and meeting participants’ needs
      • Solutions :
        • 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
    • 49. 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
    • 50. 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
    • 51. (layer 2 page) Sub-menu based on researcher readiness/status
    • 52. 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
    • 53. 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
    • 54. 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
    • 55. 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
    • 56. 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
    • 57. 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
    • 58. 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
    • 59.
      • Continuum of Pediatric research and health care center programs:
        • Diabetes, Cancer, Liver disease, Sickle cell disease, Neuroscience, HIV/AIDS, Developmental Disorders, Health disparities, Organ and Stem cell transplant
      • Goals: bridge expertise at Children’s Hospital at Montefiore, other clinical sites, with ICTR
      • Challenges: physical separation, integration of education and research initiative, build a cadre of pediatric researchers
      • Solutions: incorporate translational research experience into medical school, residency, and post-graduate medical education curricula
    • 60.  
    • 61. Harvard Clinical and Translational Sciences Center
      • Children’s Hosp. Boston, MGH, NICUs at partner hospitals, DFCI, plus university-wide and community pediatrics efforts.
      • PI – Lee Nadler. Pediatric Representative: Ellis Neufeld
      • Exceptional breadth and depth of C/T research
        • Multicenter networks site for pediatric heart network, renal transplantation network, asthma network, pediatric AIDS clinical trials, COG, PBMTC, neonatal studies, etc.
        • CHB hosts one of the former 6 PGCRCs; four GCRCs in total; budget ~$18MM
        • Translational Research Program (CHB)
      • Strong extramural research funding (CHB FY2007 direct cost expenditures $135M)
        • Federal $73M research, industry $3.5M, Foundation $12.9M, Philanthropy $20.9M
      • Major pediatrics training center(s)
        • >300 fellows in more than 30 training programs
        • Existing K12 programs in pediatrics, non-malignant hematology, others
        • Predoctoral, K12, K30 and C/T masters programs in CTSC
      • Strong pediatric participation in CTSC leadership
        • External pediatric oversight committee
        • CHB CEO on highest internal comm.
        • 3 pediatricians on operations comm.
        • Representation in all areas of CTSC
    • 62.
      • Goals
        • 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.
      • Current Barriers:
        • Very Large enterprise across Harvard community; “silos” within programs/hospitals. Modest incremental funding. Changes in ancillary support of GCRC model.
      • Proposed solutions.
        • 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.
    • 63. Voting Member: Ram Yogev, M.D. Alternate Member: Leon Epstein M.D.
      • Children’s Memorial Hospital: 266 bed free standing tertiary children’s hospital; all sub-specialties; serves population of 8.5 million in Chicago.
      • Clinical Research Unit:
        • Dedicated 4 bed ambulatory unit; 1400 research visits/yr
        • Scatter Beds; 20-25 inpatient research subjects/yr; (not including ped oncology protocols).
        • Personnel: director; admin assist, nurse manager;
          • 4.5 nurses, 1.0 research coord;
        • 1.5 research pharmacists.
    • 64.
      • Goals:
      • 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.
      • Current Barriers:
      • Pediatric research competes for resources in the larger adult CSTA.
      • Inpatient beds for research are limited due to high occupancy rates.
      • Potential Solutions:
      • Independent funding for pediatric CTSAs
      • Dedicated inpatient research unit
      • .
    • 65. 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.
    • 66. Nationwide Children’s Hospital
      • 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.
    • 67. 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
    • 68. 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
        • services on-site.
    • 69. 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
        • quality research.
        • Potential Solutions : Provide support for all research related
        • activities (administrative, study coordinators, bionutrition,
        • laboratory, biostatistics); provide time and resources for new
        • investigators (through grants); enhance collaboration; reduce
        • barriers through education and computerization.
    • 70.  
    • 71.
      • 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
    • 72. 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.
    • 73. 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
    • 74. 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
    • 75. 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
    • 76. 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
    • 77.
      • Pediatric Goals
      • Increase the number of pediatric investigators via both training and recruitment
      • Enhance access of children in South Texas to research innovation
      • Build pediatric research infrastructure in the Children’s Hospital and the region
      • Broaden collaboration across the age spectrum
      • Expand the network of pediatric investigators/investigations across the region
      • Current Barriers
      • High clinical patient volumes and clinical demands
      • Limited education, low socioeconomic status, high uninsured rate in population
      • Socio-cultural, immigration and geographic issues
      • Lack of shared vision (what we can be, not what we are)
      • Underdeveloped local philanthropy/endowment
      • Small core of NIH-experience clinical pediatric investigators
      • Potential Solutions
      • “Sell” the CHART Center to pediatric researchers throughout the region
      • Create (by training or recruitment) a larger core of pediatric researchers
      • Make clinical research more visible and a “viable career” for pediatric trainees
      • Focus efforts of development campaign on children’s research benefits
      • Collaborate across CTSAs state-wide/nationally (unified IRB and data systems)