National COVID Cohort Collaborative (N3C) Data Exchange For Emerging/Novel Diseases ( DEFEND) Internal Team Rob Star, NIDDK Ken Gersing, NCATS Stephen Hewitt, LP, NCI Michael Kurilla, NCATS Sam Michael, NCATS Joni Rutter, NCATS External Imaging Advisors Fred Prior, U of Arkansas for Medical Sciences Joel Saltz, SUNY/Stony Brook
Re-engineering Clinical Research Interdisciplinary Research Public-Private Partnerships - Innovator Award Bench Bedside Practice Building Blocks and Integrated Research Networks Translational Pathways Clinical Research Informatics Research Molecular Libraries, NIH Clinical Research Associates Initiatives Bioinformatics, Clinical outcomes Computational Biology, Nanomedicine Cross cutting: Harmonization, Training
Typical NIH Network Academic Health Center Sites & Data Coordinating Center
Interoperable Networks Share Sites and Data
Integration of Clinical Research Networks • Link existing networks so clinical studies and trials can be conducted more effectively • Ensure that patients, physicians, and scientists form true “ Communities of Research ”
Re-engineering the Clinical Research Enterprise National Clinical Research System Plan and start a few demonstration Funding mechanism to sustain national networks system through consensus of all creates effectiveness data that moves constituents ( “ 1% solution ” ) Simplify complex regulatory systems – rapidly into the community AND data on outcomes and quality of care; sustained demonstration projects Simplified regulatory system in place for efficient infrastructure to rapidly initiate networks Plan for networks in place for all institutes large clinical trials; scientific Increasing Level of Difficulty information for patients, families, advocacy groups Establish repositories of biological Data standards shared across NIH ONE medical nomenclature with national specimens and standards for collection institutes data standards (agreed to by NIH, CMS, FDA, DOD, CDC) Standardize nomenclature, data standards, Data standards updated ‘ in real time ” core data, forms for most major diseases Funding mechanisms evaluated to through networks Start a library of these elements shared determine which are most efficient between institutes and NLM National repository of images and samples Critical national “ problem list ” Develop efficient network administration infrastructure at NIH Most efficient network funding mechanisms Develop standards for capturing images for in place across NIH research Create NIH standards to provide “ safe NIH standards for safe haven in place Participation in research is a professional haven ” for clinical research standard (taught in all health professions Regulations and ethics harmonized with schools) Inventory and evaluate existing public- FDA, CMS private partnerships, networks, CR Study, evaluation and training regarding Public private partnership mechanisms in institutions, and regulatory systems clinical research a part of every medical place school, nursing school, pharmacy school Establish FORUM(S) of all stakeholders 100,000 members of certified “ Clinical Clinical research practices documented Research Corps ” Establish standards for and pilot creation of and updated regularly to maintain safe a National Clinical Research Corps Standards shared across NIH haven Demonstration/planning grants to 2002-3 Networks provide detailed training about enhance/evaluate/develop model networks network specific issues 1-3 years 4-7 years 8-10 years Time
Re-engineering the Clinical Research Enterprise National Clinical Research System Plan and start a few demonstration Funding mechanism to sustain national networks system through consensus of all creates effectiveness data that moves constituents ( “ 1% solution ” ) Simplify complex regulatory systems – rapidly into the community AND data on outcomes and quality of care; sustained demonstration projects Simplified regulatory system in place for efficient infrastructure to rapidly initiate networks Plan for networks in place for all institutes large clinical trials; scientific Increasing Level of Difficulty information for patients, families, advocacy groups Establish repositories of biological Data standards shared across NIH ONE medical nomenclature with national specimens and standards for collection institutes data standards (agreed to by NIH, CMS, FDA, DOD, CDC) Standardize nomenclature, data standards, Data standards updated ‘ in real time ” core data, forms for most major diseases National Clinical Research System creates Funding mechanisms evaluated to through networks Start a library of these elements shared determine which are most efficient effectiveness data that moves rapidly into the between institutes and NLM National repository of images and samples Critical national “ problem list ” Develop efficient network administration community AND data on outcomes and quality of infrastructure at NIH Most efficient network funding mechanisms care; sustained efficient infrastructure to rapidly Develop standards for capturing images for in place across NIH research initiate large clinical trials; scientific information for patients, families, advocacy groupsz Create NIH standards to provide “ safe NIH standards for safe haven in place Participation in research is a professional haven ” for clinical research standard (taught in all health professions Regulations and ethics harmonized with schools) Inventory and evaluate existing public- FDA, CMS private partnerships, networks, CR Study, evaluation and training regarding Public private partnership mechanisms in institutions, and regulatory systems clinical research a part of every medical place school, nursing school, pharmacy school Establish FORUM(S) of all stakeholders 100,000 members of certified “ Clinical Clinical research practices documented Research Corps ” Establish standards for and pilot creation of and updated regularly to maintain safe a National Clinical Research Corps Standards shared across NIH haven Demonstration/planning grants to 2002-3 Networks provide detailed training about enhance/evaluate/develop model networks network specific issues 1-3 years 4-7 years 8-10 years Time
Re-engineering the Clinical Research Enterprise National Clinical Research System Plan and start a few demonstration Funding mechanism to sustain national networks system through consensus of all creates effectiveness data that moves constituents ( “ 1% solution ” ) Simplify complex regulatory systems – rapidly into the community AND data on outcomes and quality of care; sustained demonstration projects Simplified regulatory system in place for efficient infrastructure to rapidly initiate networks Plan for networks in place for all institutes large clinical trials; scientific Increasing Level of Difficulty information for patients, families, advocacy groups Establish repositories of biological Data standards shared across NIH ONE medical nomenclature with national specimens and standards for collection institutes data standards (agreed to by NIH, CMS, FDA, DOD, CDC) Standardize nomenclature, data standards, Data standards updated ‘ in real time ” core data, forms for most major diseases National Clinical Research System creates Funding mechanisms evaluated to through networks Start a library of these elements shared determine which are most efficient effectiveness data that moves rapidly into the between institutes and NLM National repository of images and samples Critical national “ problem list ” Develop efficient network administration community AND data on outcomes and quality infrastructure at NIH Most efficient network funding mechanisms of care ; sustained efficient infrastructure to Develop standards for capturing images for in place across NIH research rapidly initiate large clinical trials; scientific information for patients, families, advocacy Create NIH standards to provide “ safe NIH standards for safe haven in place Participation in research is a professional groups haven ” for clinical research standard (taught in all health professions Regulations and ethics harmonized with schools) Inventory and evaluate existing public- FDA, CMS private partnerships, networks, CR Study, evaluation and training regarding Public private partnership mechanisms in institutions, and regulatory systems clinical research a part of every medical place school, nursing school, pharmacy school Establish FORUM(S) of all stakeholders 100,000 members of certified “ Clinical Clinical research practices documented Research Corps ” Establish standards for and pilot creation of and updated regularly to maintain safe a National Clinical Research Corps Standards shared across NIH haven Demonstration/planning grants to Networks provide detailed training about enhance/evaluate/develop model networks network specific issues 1-3 years 4-7 years 8-10 years Time
National COVID Cohort Collaborative (N3C) 7/2020
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