Trial Funding and Engagement: The NIH Sponsored CTSA Program

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Presentation transcript:

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

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

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 Established in 2011 – after the CTSAs were established NCATS with a budget of $575 million NIH Director Dr. Francis S. Collins, M.D., Ph.D. “Patients suffering from debilitating and life threatening diseases do not have the luxury to wait the 13 years it currently takes to translate new scientific discoveries into treatments that could save or improve the quality of their lives. The entire community must work together to forge a new paradigm, and NCATS aims to catalyze this effort.”

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 Consultations Connections to collaborators & research projects Education Graduate certificate, Masters, and PhD programs Professional development Fellowship and career development programs

Trial Innovation Network (TIN) & Tufts CTSI Clinical Research Network (CRN) Ten Institutions Tufts Medical Center Infrastructure Workgroups & Thematic Panels Maine Medical Center Baystate Medical Center St. Elizabeth’s Medical Center Lahey Hospital and Medical Center Newton-Wellesley Hospital Rhode Island Hospital Jean Mayer USDA Human Nutrition Research Center On Aging MIT

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

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 Increased Pilot Award Funding & Community Catalysts Awards More TL2 and KL2 Training Slots

Key Clinical Research Study Quality Touchpoints

That’s All Folks!