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Day 2: Thierry Lacaze-Masmonteil, Maternal Infant Child Youth Research Network
1. MICYRN – Connecting Minds and Removing Barriers to
High-Quality Health Research
CORD conference – Ottawa
June 08th, 2022
2. MICYRN respectfully acknowledges the Indigenous
Peoples of all the lands. From coast to coast to
coast, we acknowledge the ancestral and unceded
territory of all the Inuit, Métis, and First Nations
people that call this land home.
Please take a moment, in your own time, to reflect
and recognize the lands you are logging in from
today
https://native-land.ca/
3. A national maternal/child health
research network
• Established in 2006
• Linking all of the 18 child and the three of the largest maternal health research
organizations in Canada
• Incorporated non-profit, registered charity 2011
• BOD, executive team, with coordinating centre in BC
• Funded by RIs, Foundations and Departments (also supplemented by CIHR and
Genome Canada via Rare Diseases Network, Canadian Childhood Cannabinoid
Clinical Trials Network, some fee-for-service support agreements with other
organizations).
5. National Coordinating Centre
Logistical Support
Communication and KT
Finances and Project Management
Maintaining Partnerships
MICYRN Board of Directors
Associate
Director
Clinical Trials
Scientific
Director
Executive
Director
Engagement
Associate
Administrative
Assistant
Clinical Trials Platform
• Pediatric Clinical Research Units
at 18 Academic Child Health
Centers : The “consortium”
• ARO services – Delegated tasks
of sponsorship
MICYRN Research Organization
Members
MICYRN
Executive
6. Affiliated Hospitals and Research
Organizations
BC Children’s Hospital (Vancouver) BC Children’s Hospital Research Institute
Alberta Children’s Hospital (Calgary) Alberta Children’s Hospital Research Institute
Stollery Children’s Hospital (Edmonton) Women & Children’s Health Research Institute
Jim Pattison Children’s Hospital (Saskatoon) Dept of Pediatrics, University of Saskatchewan
Children’s Hospital (Winnipeg) Children’s Hospital Research Institute of Manitoba
Children’s Hospital at London Health Sciences Children’s Health Research Institute – Western U
McMaster Children’s Hospital (Hamilton) Dept of Pediatrics, McMaster University
Sick Kids (Toronto) Sick Kids Research Institute
Holland Bloorview Kids Rehab Hospital (Toronto) Bloorview Research Institute
Mont Sinai Hospital (Toronto) Lunenfeld-Tanenbaum Research Institute
Sunnybrook Hospital (Toronto) Sunnybrook Health Sciences Centre
Kingston Health Sciences Centre Dep of Pediatrics, Queen’s University
Children’s Hospital of Eastern Ontario (Ottawa)) CHEO Research Institute
Montreal Children’s Hospital Research Institute at McGill U Health Centre
CHU Sainte-Justine (Montreal) Centre de Recherche Sainte-Justine
Hopital Fleurimont (CHUS, Sherbrooke) Dept of Pediatrics, University of Sherbrooke
CHUL et Centre mere-enfant Soleil (Quebec City) Centre de Recherche du CHU de Quebec, Laval U
IWK Health Centre (Halifax) IWK Health Centre
Janeway Children’s Health Centre (St. John’s) Dept of Pediatrics, Memorial University
7. Advocacy and National
Partnerships
• Maternal/Child and Youth Health Research Director Council – national voice and
direction, collaborative opportunities, COVID-19 challenges/approaches, advocacy
• Paediatric Chairs of Canada (PCC) – advocacy, resident research
• Children’s Healthcare Canada (CHC) – clinical investigation unit partnerships with
hospitals, advocacy
• Health Canada: OPPI and OCT – coordinated advocacy, consultation
- GPFC, CPS, CHC, PCC, C17, other networks, institutions
- Agile Regulation – Modernizing Pediatric Clinical Trials Regulations
- Patented Medicines Pricing Review, Pediatric Drug Action Plan
- National Strategy on High-Cost drugs for Rare Diseases
8.
9. National Collaborations
• Rare Diseases: Models & Mechanisms Network (RDMM)
• Canadian Childhood Cannabinoid Clinical Trials Network
• MICYRN and Child Bright partnering for renewal (CIHR SPOR network – chronic
diseases): Lessons learnt from Child Bright #1
• Canadian Pediatric COVID 19 research Platform (NPI Dr. Caroline Quach): MICYRN
coordinating centre.
10. National Pediatric Clinical Trials
Infrastructure
Tactics to improve Canadian child health through increased access to high-quality
clinical trials supported by an efficient, safe, and family-centered national
infrastructure.
1. Support the development of clinical trials unit (CTU) capability across the
research organizations (e.g. national CTU capability database, delegated
sponsorship tasks)
2. Develop multicentre trial guidance tools and resources (e.g. trials checklists,
contracts lawyer network, support for trials submissions to Health Canada)
3. Build expertise as the “single-point” of contact for clinical trials to for the
investigator community and industry (expertise pool of investigators, specialty
research networks and industry centres of excellence)
11. Removing Barriers
• Through partnerships with academia, MICYRN is assisting international and
national investigators in the planning, development, and execution of non-
oncology, multi-centre, maternal/child health clinical trials
• Centralized national infrastructure
• Academic Research Organization (ARO)-like function
12. ARO Services
Pre-Award Services (In-kind) Post-Award Services (Cost Recovery)
Protocol Transition
Health Canada Regulatory Submissions
Harmonized Ethics Support
Cross Institutional Monitoring Program
Contracts Facilitation
Safety and Adverse Event Reporting
Data Management
Project Management
Placebo Development and Drug Procurement
Consultation (Regulatory and Budget)
Scientific Depth and Protocol Optimization
Letter of Support
13. Clinical Trial Sponsorship
• Increase the number of CTs
that Canadian children can
participate in
• Acquired clinical trial
insurance
• Serve as the Canadian
Regulatory Sponsor for
investigator initiated clinical
trials
14. Proposal to Establish a Canadian
Maternal/Child Health Clinical Trial
Infrastructure to Support Canada’s
National Strategy on High-Cost Drugs
for Rare Diseases
• Ensure effective novel therapeutics and interventions are
available for children and their families with rare diseases
• Improve equal access to, and foster diversity and inclusion in
clinical trials
• Implement processes to acquire data from CTs, real world
data, registries
• Generate high quality data to inform HC and facilitate
decision making processes for access and pricing