Establishing a Canadian Child Health Research Network

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Establishing a Canadian Child Health Research
Network November 2004
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Why child health research?

• Pediatric diseases have a greater component of
  genetic determinants than adult diseases
• Antecedents of adult diseases can be found in
  pediatric populations
• Children are a manageable population sector
• Child health leads to a stronger economic base
  healthy children today means healthy adults
  (working population) tomorrow
• Children have been identified as a
  unique/vulnerable research population

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The external context favours the establishment of
a child health research network (I)

• Changing public expectations (relevance,
  knowledge transfer, technology transfer and
  ethics, as criteria for excellence)
• Big - big science (theme based funding,
  programs rather than projects, expected return on
  investment)
• Emphasis on quality in research oversight
• Competition for staff/trainees

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The external context favours the establishment of
a child health research network (II)

• Investment in research is continuing
• The requirement for institutional participation
  in many matching programmes would be
  facilitated by a network
• Opportunity to blend both federal and provincial
  funding
• Possibility of attracting private funds through
  national fund-raising activities

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Opportunity for a Child Health Research Network

• Research on children has unique elements, in
  particular their developmental processes
• Knowledge transfer may be especially feasible on
  issues of child health
• Increasing emphasis on translation research the
  idea that translation research is feasible has
  become established in past 10 years
• Increasing emphasis on multi-centre research
• Opportunity to build competence and capacity and
  minimise / eliminate weaknesses

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Goals for a Pediatric Research Network

• 1. To improve health outcomes by implementing
  research advances
• (Connect basic scientists, clinician-scientists
  and health practitioners)
• 2. To take advantage of the Canadian health care
  system
• (Marry national health care system with
  entrepreneurial science system)
• 3. To improve funding for pediatric research
• (Create effective lobby for child health
  research)

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Goals for a Pediatric Research Network

• 4. To establish and develop research partnerships
• (Enable collaboration through existing networks
  present at this meeting, among others)
• 5. To enlist provincial partnerships
• (Allow each centre to obtain support from its
  province)
• 6. To spread a climate of research throughout the
  country
• (Make all institutions partners in research)
• 7. To improve support to existing networks
• (Create infrastructures common to all networks)

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Use of new resources

• Personnel
• Salaries of investigators
• Enhanced national training programs
• Infrastructure
• Specific research support (CIUs, CEUs, data
  bases)
• Indirect costs
• Capital projects

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First step development of a national child
health clinical research network

• Components of Clinical Research Support
• Clinical Investigation Unit/Clinical Research
  Centre
• Clinical Trials Consortium
• Health Services, Economics and Policy/Advocacy
  Research
• Data Management
• Knowledge Transfer
• Pediatric Clinical Research Institutional Support
  and Oversight

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1. Clinical Investigation Unit/Clinical Research
Centre

• Local, regional, national and/or virtual
• Some or all of
• bed space, exercise physiology, research
  pharmacy, access to imaging, pool of specialized
  personnel, behavioural research unit, etc.

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2. Clinical Trials Consortium

• Work with existing groups or develop new program
• Provide methodological support, standardized
  contracts, ethics, data management, coordinated
  oversight
• Network of individuals with similar roles to
  create standard operating procedures, develop
  education and training
• Opportunity to attract funding
• Link to industry

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3. Health Services, Economics and Policy/
Advocacy Research 4. Data Management 5.
Knowledge Transfer 6. Clinical Research
Institutional Support and Oversight (Harmonizatio
n of research ethics boards, contracts, policies
and procedures re CTAs, continuing review)
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The Sick Kids Clinical Research Pathway
CLINICAL
RESEARCH
Clinical Research Secretariat
Medical Advisory Committee
PRINCIPAL INVESTIGATOR
Clinical Research Office
Clinical Departments
STUDY MANAGEMENT
DISSEMINATION
SCIENCE
OVERSIGHT
APPROVALS

• Health Care Team
• - Clinical Practice
• - Rounds
• Research Subjects
• Patients
• Individual Results
• Summary Results

Education Study Audit Monitoring
Division / Dept Clinical Services Clinical
Program
Patients Patient Care policy Safe Location
Clinical Department Research Directors
Clinical Research Centre (Nursing, Beds,
Exercise Lab) Staff Education Template
SOPs Study Budgets Data Management
Biostatistics (CRSU)
Study Design
Grants Contracts
(Clinical Research Support Unit CRSU)
Peer Scientific Reviews

• Colleagues
• - Conferences
• - Peer review journals
• Public
• Advocacy Groups
• Granting Agencies
• Media

HEALTH CANADA ( / or FDA )
HEALTH CANADA ( / or FDA )
RESEARCH ETHICS BOARD
RESEARCH ETHICS BOARD
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NIH Regional Translational Research Centers (RTRC)

• Phase 1 3 Million in 2005 for 20 grants to
  conceptualize/design three models of RTRCs
• regional centres with clinical research services
  (e.g. protocol design, data management/biostatisti
  cs, regulatory including Good Clinical Practices
  and Good Laboratory Practices, REB, subject
  recruitment, pilot project support, staff)
• core laboratory technology centres (e.g, imaging,
  animal toxicology, real time PCR, genetic and
  microarray statistical support, pharmacokinetics,
  including LC-MS)
• hybrid of regional and core
• Phase 2 Infrastructure for translational
  research (RFP in 2006 for 8-10 RTRC worth 27
  Million)

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Questions regarding a national child health
research network

• Are there sciences/clinical problems particular
  to children? (if Childrens hospitals dont study
  them, no one else will)
• Are there competitive advantages to coordinating
  research at pediatric centres?
• What approaches would work best to enlist all
  partners in our common objectives?
• What measures (scientific or other) could be used
  to gauge success of such a Network?

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Next steps to develop the clinical research
network

• Receive endorsement from this group
• Each centre will establish its needs and
  participation in network
• Begin to implement aspects that require little
  money identify local lead individuals
• Compete for CIHR/CFI RFPs when they are announced
• Write a full application