Pediatrics Oversight Committee Report to CTSA PIs

1
Pediatrics Oversight Committee Report to CTSA PIs

• December 18, 2007

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Pediatric Oversight Committee

• March 22, 2007. Initial meeting, 12 CTSA sites
• Elected Dr. Jennifer Puck of UCSF as Chair
• Identified distinctive features of pediatric
  research
• Recommended inclusion of a pediatric researcher
  on other CTSA committees
• Quarterly phone meetings
• September 11, 2007. Pediatric IRB Web Conference
• Fall, 2007. Pediatric Oversight Committee
  enlarged with new CTSA sites. Fulfills mandate
  to incorporate pediatric component into CTSA
  Programs.

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Pediatric IRB Web Conference September 11, 2007

• Presented and discussed cases
• Addressed issues raised by cases
• Variability in IRB review, implications for
  multicenter studies
• Definition of minimal risk
• Definition of who has a disorder or condition
  (allowing minor increase over minimal risk in
  research)
• Formulated outcomes
• Publish case summaries and the points they
  illustrate
• Encourage investigators with multi-site studies
  to post on the secure CTSA Wiki for pediatrics
• Constitute a national group of experts in
  pediatric ethics for prospective consultation
  about study designs, consent forms in planned
  pediatric research

4
CTSA Meeting September 25, 2007

• Announced 12 new CSTA awards
• Solidified working groups on high priority issues
• Ethics in Pediatrics build on momentum from web
  conference Alex Kon, UC Davis, and Steve
  Hirschfeld, NIAID
• Rare diseases Robert Steiner, OHSU, and Jennifer
  Puck, UCSF
• Identifying drug and device companies that
  support pediatric research and development
  Jennifer Li, Duke and Carole Marcus, U Penn
  CHOP
• Reviewed additional issues
• Sharing resources for training (e.g. specialized
  courses) and research (e.g. consent templates)
• Conducting joint pediatric and adult studies

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Pediatrics Oversight Committee Workgroups

• Rare Diseases Workgroup
• Cross-cutting collaborative efforts with Dr.
  Elaine Collier, NIH Office of Rare Diseases,
  Clinical Research Network and others
• Plan vision-defining call with a few recognized
  experts
• Offer some specific goals at next POC meeting
• Pediatric Drug and Devices Workgroup

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POC Upcoming Challenges and Plans

• Workgroup membership and goals to be solidified
• Leadership by 1 or 2 POC members
• Participation by pediatricians at CTSA sites
• Non-CTSA membership to supply additional
  expertise
• Non-pediatricians welcome
• Next POC Meeting by Adobe-Connect on January 4,
  2008
• Face-to-Face meeting in Bethesda planned for
  May-June, 2008
• Get access to Wiki Space, learn to use it
• Clarify mechanisms for POC communication with
  other CTSA groups

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Demonstration of CSTA POC Strength

• NICHD request published Dec. 7 (due in lt2 weeks
  on Dec. 20!) invites
• 'Capability Statements' to inform an upcoming RFA
  for a national Newborn
• Screening Translational Research Network
  Coordinating Center.
• http//www2.fbo.gov/spg/HHS/NIH/NICHD/Reference2D
  Number2DNICHD2DMRDD2DNewborn/SynopsisR.html
• Response being written by members of the CTSA
  community
• Nancy Green, Columbia Jennifer Puck UCSF Bob
  Steiner, OHSU
• Distributive model based on Childrens Oncology
  Group, inviting
• POC members emailed, asked to forward to likely
  participants
• 27 experts at 14 current CTSA sites have already
  responded with
• enthusiasm metabolic disease,
  hemoglobinopathies, other screened
• disorders, public health and ethical issues of
  newborn screening
• Proof of concept of CTSA ad hoc networks can
  function as a platform to
• support and integrate multi-disciplinary and
  multi-institutional research