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Trial Funding and Engagement: The NIH Sponsored CTSA Program

Trial Funding and Engagement: The NIH Sponsored CTSA Program. Jonathan Davis, MD Vice-Chair of Pediatrics Chief of Newborn Medicine Tufts Medical Center Professor of Pediatrics Tufts University Chair, Neonatal Advisory Committee Office of Pediatric Therapeutics FDA.

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Trial Funding and Engagement: The NIH Sponsored CTSA Program

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  1. Trial Funding and Engagement: The NIH Sponsored CTSA Program Jonathan Davis, MD Vice-Chair of Pediatrics Chief of Newborn Medicine Tufts Medical Center Professor of Pediatrics Tufts University Chair, Neonatal Advisory Committee Office of Pediatric Therapeutics FDA

  2. Major Challenges in Medical Research • Slow pace, cost, regulatory roadblocks, public trust • Translation to actual impact on health • Research relevance – broadly-engaged team science • Common terminology, data elements, data sharing • Vulnerable populations (pregnant women, children) • Integration and coordination between Academic Medical Centers and Community-based Hospitals

  3. Clinical and Translational Science Award (CTSA) Program • Established by NIH in 2006 • A national consortium of >50 research institutions • Under the National Center for Advancing Translational Sciences (NCATS), one of 27 NIH Institutes and Centers established in 2011 • Mission: to develop innovative solutions that will improve the efficiency, quality, and impact of the process for turning observation in the laboratory, clinic, and community into interventions that improve the health of individuals and the public

  4. Clinical and Translational Science Institutes (CTSIs) • Research Service • Study design & analysis • Clinical study & regulatory support • Informatics • Conveners & Connectors • Team Science • Collaboration • Multidisciplinary • Stakeholder & community-engagement • Change • Innovation & transformation • Science of Science • Process improvement • Address roadblocks • Education • Graduate certificate, Masters, and PhD programs • Professional development • Fellowship and career development programs

  5. Trial Innovation Network (TIN) & Tufts CTSI Clinical Research Network (CRN) CRN TIN

  6. Tufts CTSI Clinical Research Network Drivers • Grow Industry-sponsored clinical research • Access to multiple sites through a single federated research system • Expedite PI-initiated clinical research • expand eligible participant populations; facilitate collaborations; conceive, design, and conduct innovative clinical research • Build capacity and infrastructure to conduct multisite clinical studies to serve the NIH and the nation

  7. How Does Tufts CTSI Help Researchers? • Consultations • Connections to collaborators & research projects • Research design & analysis support • Clinical study support; single & multi-site trial support • Regulatory support • Informatics tools – cohort discovery • Pilot Awards • Training & education opportunities • CTS Graduate Program • TL1/KL2 Programs • Professional Education

  8. Key Clinical Research Study Quality Touchpoints

  9. That’s All Folks!

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