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Institute for Advanced Clinical Trials for Children

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Presentation on theme: "Institute for Advanced Clinical Trials for Children"— Presentation transcript:

1 Institute for Advanced Clinical Trials for Children
FDA Pediatric Clinical Investigator Training Workshop Ed Connor, MD, MBE, FAAP Chairman and Chief Medical Officer February 28, 2019

2 I-ACT for Children: Scope
An independent 501(c)3 public-private collaboration to advance innovative medicines and device development and labeling to improve child health. Formally launched March 2017. Strategy & Planning Tools, Capabilities, Best Practices Infrastructure & Trial Execution Access and Global Reach Quality and Efficiency Consistency and Competency Innovative trial design Site feasibility assessment Independent assessment of programs/strategy including PIPs, PSPs, protocols Protocol optimization Use of real-world data Standard processes & practices Site optimization Centralized ethics review Pediatric-based GCP & other education Geographically diverse centers of excellence Pre-qualified trial-ready sites Patient recruitment strategies/materials Efficiency metrics, troubleshooting, training Engaging stakeholders to generate discussion, launch groundbreaking initiatives Shaping an environment that embraces the need for/adoption of trial innovation Thought Leadership Experience and Proficiency

3 I-ACT for Children: Membership & Support
Contributors Membership, grants & donations Revenue from services in each of the 4 areas of focus UO18 Grant Pro-rated annual membership based on R&D spend Five-year membership followed by renewable annual membership Annual membership Members

4 Our Collaborative Network
I-ACT Centers of Excellence Example I-ACT Alliance Organizations James M. Anderson Center for Health Systems Excellence Pediatric Specialty Networks Key Global Collaborators - GPCTN Example Advocacy Collaborators Japan Clinical Trials Network

5 Engagement Opportunities
Membership Centers of Excellence – network Experts and consultants (CSGs) Pilot program for new and start-up sites/PIs/coordinators Quality improvement program Education & training modules, meetings, conferences For more information contact: Steve McConoughey

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