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Institute for Advanced Clinical Trials for Children

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. I-ACT for Children: Scope.

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Institute for Advanced Clinical Trials for Children

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  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 Infrastructure& Trial Execution • Geographically diverse centers of excellence • Pre-qualified trial-ready sites • Patient recruitment strategies/materials • Efficiency metrics, troubleshooting, training • Innovative trial design • Site feasibility assessment • Independent assessment of programs/strategy including PIPs, PSPs, protocols • Protocol optimization • Use of real-world data Access and Global Reach Quality and Efficiency Tools, Capabilities, Best Practices Thought Leadership • Engaging stakeholders to generate discussion, launch groundbreaking initiatives • Shaping an environment that embraces the need for/adoption of trial innovation • Standard processes & practices • Site optimization • Centralized ethics review • Pediatric-based GCP & other education Consistency and Competency Experience and Proficiency

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

  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 Example Advocacy Collaborators Key Global Collaborators - GPCTN 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 stephen.mcconoughey@iactc.org

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