The CTSA Collaborative Vision: Enhancing Pediatric Clinical Research

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The CTSA Collaborative VisionEnhancing
Pediatric Clinical Research

• Anthony Hayward, MD, PhD
• Director, Division of Clinical Research
  Resources,
• NCRR
• Pediatric Drug Device Development Workshop
• Expectations Specifications
• 26 February 2009

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What is the Clinical Translational Science
Award Program?

• A National Consortium Of Academic Health Centers
  Funded By NCRR
• CTSAs conduct clinical translational research
  with a goal of providing new treatments quickly
  efficiently to patients throughout their lifespan

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Why CTSAS?

• The CTSA Program was created to solve problems
  identified by clinical investigators
• Lack of infrastructure and support
• Studies take too long, cost too much
• Investigators engage in tasks for which theyre
  not prepared
• Regulatory barriers complexities
• Lack of dedicated time for clinical research
• The CTSA Consortium Strategic Plan identifies
  National Clinical Translational Research
  Capability as its 1 Priority

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Clinical and Translational Science Awards provide
essential resources for pediatric researchers
NIH other government agencies
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
CTSA HOME
Industry
Community Involvementfor Research Education
Clinical Resources
Biostatistics
Regulatory Support
Healthcare organizations
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CTSAs Building a National Consortium
Currently 38 awards across the nation
Northwestern University
Ohio State University
University of Colorado, Denver
Harvard University
Boston University
Tufts University
University of Utah
Albert Einstein College of Medicine
CT
Stanford University
Indiana University School of Medicine
University of North Carolina
Scripps Research Institute
University of Alabama, Birmingham
University of Texas Health Science Center at San
Antonio
Participating Institutions
Members 2006 2007
New Members 2008
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CTSA philosophy

• Serve NIH funded investigators, including all
  types and sizes of studies and clinical
  disciplines
• Increase the efficiency and speed of clinical and
  translational research
• Integrate translational and clinical science by
  fostering collaboration between departments and
  schools of an institution and between
  institutions and industry

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CTSA Creating National Partnership Opportunities
Working as a Consortium we have established a
committee structure to execute the
vision and goals of the CTSA program
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What does CTSA consortium provide? (NCRR
perspective)

• Resources and infrastructure to conduct clinical
  and translational research
• Opportunities to participate in shared biomedical
  informatics processes including setting data
  standards and developing common vocabularies
• Opportunity to participate in development of
  novel clinical and translational methodologies
• Multidisciplinary clinical research teams
• Potential access to existing pediatric research
  networks

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Goals of CTSA Program Support Pediatric/Child
Health Research

• Transform the local, regional and national
  environment for clinical and translational
  science,
• Increase the efficiency and speed of clinical and
  translational research.
• Bridge basic, clinical and translational research
  to bring effective strategies and treatments into
  clinical practice more rapidly.
• Create an environment that will overcome
  challenges and impediments to clinical and
  translational science.
• The consortium will work towards
• adopting and implementing best practices,
  policies, procedures
• advancing collaborative clinical and
  translational research
• reducing burdens on individual investigators at
  all institutions.

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Pediatric Component of the CTSA Consortium
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CTSA Pediatric/Child Health Resources

• 38 academic health centers
• At least 17 dedicated childrens hospitals
• Well-established pediatric research networks
  including for asthma, AIDS, Cystic Fibrosis,
  heart network, renal transplant, neonatal,
  liver-biliary
• Existing pediatric GCRCs with clinical
  regulatory expertise

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Childrens Hospitals participate in CTSAs

• St. Louis Childrens Hospital (Wash U)
• Childrens Hospital and Regional Medial Center
  (Wash)
• American Family Childrens Hospital (Wisconsin)
• Childrens Healthcare of Atlanta (Atlanta CTSI)
• CHOP (Penn)
• Childrens Hospital of Pittsburgh (Pitt)
• Childrens Oakland Hospital (UCSF)
• The Childrens Hospital at Montefiore (Einstein)
• Childrens Hospital Boston (Harvard)
• Childrens Memorial Hospital (Northwestern)
• Nationwide Childrens Hospital (Ohio)
• Childrens Health System (Alabama)
• The Childrens Hospital (Colorado)
• CHRISTUS Santa Rosa Childrens Hospital (UTHSC
  San Antonio)
• Primary Childrens Medical Center (Utah)
• Kennedy Krieger Childrens Hospital at John
  Hopkins University
• Rady Children's Hospital, San Diego (Scripps)

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CTSA Consortium Child Health Oversight Committee

• 119 members from 37/38 CTSAs
• Provides leadership, vision, and oversight of
  Consortium-wide child health activities
• Opportunity for Collaboration
• Distributed biobank for pediatric rare disease to
  serve multiple CTSAs
• External academic partnership with PAS
• 6 workgroups
• Pediatric Drug Devices
• Others Pediatric Research Ethics, Rare Diseases,
  T2 Research, Lifespan, Metrics of Success

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CTSA Consortium-Wide Projects that Support Child
Health

• Administrative supplements
• 2.5 million in FY 2008 to support
  consortium-wide projects including

• Informatics National web portal for research
  volunteers
• Virtual Biobanks for Multicenter Research on
  Pediatric Rare Diseases
• CTSA National Resource Database for Translational
  (T1) Research
• Up to 5M in 2009 for Research on Outcome
  Measures for Pediatric Clinical Trials
  NOT-NCRR-09-005

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CTSA Infrastructure Supports Research Of NIH
Categorical Institutes
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Goal for Todays Meeting

• To formulate specifications for a national child
  health clinical research infrastructure to
  effectively and efficiently develop drugs and
  medical devices for children

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Acknowledgements

• NICHD collaborators
• Speakers and panelists
• Conference participants