Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1384&sort=-title
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-title", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1442&sort=-title", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1385&sort=-title", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1383&sort=-title" }, "data": [ { "type": "Grant", "id": "8139", "attributes": { "award_id": "3U24TR001608-06S1", "title": "ACTIV-6", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 23494, "first_name": "Sarah", "last_name": "Dunsmore", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-04-17", "end_date": "2023-06-30", "award_amount": 77049200, "principal_investigator": { "id": 21094, "first_name": "DANIEL K.", "last_name": "BENJAMIN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23026, "first_name": "Susanna", "last_name": "Naggie", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 24010, "first_name": "Adrian", "last_name": "Hernandez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the oral treatment of COVID-19 infection in the outpatient setting. To address this unmet need the Duke Clinical Research Institute, Vanderbilt University Medical Center and partners are coming together to coordinate ACTIV-6 as a platform with a master clinical trial protocol that can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19.", "keywords": [ "Address", "Adult", "Agreement", "Budgets", "Child", "Childhood", "Clinical", "Clinical Research", "Clinical Trials", "Collection", "Complement", "Complex", "Conduct Clinical Trials", "Consumption", "Contracts", "Country", "Enrollment", "Ensure", "Feasibility Studies", "Funding", "Funding Opportunities", "Goals", "Health", "Infant", "Informatics", "Information Dissemination", "Information Systems", "Infrastructure", "Institution", "Institutional Review Boards", "International", "Language", "Learning", "Measures", "Methods", "Monitor", "Multi-Institutional Clinical Trial", "Multicenter Trials", "National Institute of Child Health and Human Development", "Participant", "Patients", "Pediatrics", "Principal Investigator", "Process", "Protocols documentation", "Public Health", "Records", "Registries", "Research", "Research Design", "Research Institute", "Research Methodology", "Research Personnel", "Research Support", "Resources", "Site", "Standardization", "Time", "Underserved Population", "United States", "United States National Institutes of Health", "Universities", "Vision", "Work", "biomedical informatics", "collaborative trial", "cost", "design", "electronic consent", "human subject", "improved", "innovation", "interoperability", "multi-site trial", "novel", "novel therapeutics", "operation", "programs", "recruit", "response", "stem", "success", "trial design", "web portal" ], "approved": true } }, { "type": "Grant", "id": "11049", "attributes": { "award_id": "3U24TR001608-07S1", "title": "ACTIV-6", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 23494, "first_name": "Sarah", "last_name": "Dunsmore", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-26", "end_date": "2023-06-30", "award_amount": 20600000, "principal_investigator": { "id": 21094, "first_name": "DANIEL K.", "last_name": "BENJAMIN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23026, "first_name": "Susanna", "last_name": "Naggie", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 24010, "first_name": "Adrian", "last_name": "Hernandez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the oral treatment of COVID-19 infection in the outpatient setting. To address this unmet need the Duke Clinical Research Institute, Vanderbilt University Medical Center and partners are coming together to coordinate ACTIV-6 as a platform with a master clinical trial protocol that can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19.", "keywords": [ "Address", "Adult", "Agreement", "Budgets", "Child", "Childhood", "Clinical", "Clinical Research", "Clinical Trials", "Collection", "Complement", "Complex", "Conduct Clinical Trials", "Consumption", "Contracts", "Country", "Enrollment", "Ensure", "Feasibility Studies", "Funding", "Funding Opportunities", "Goals", "Health", "Infant", "Informatics", "Information Dissemination", "Information Systems", "Infrastructure", "Institution", "Institutional Review Boards", "International", "Language", "Learning", "Measures", "Methods", "Monitor", "Multi-Institutional Clinical Trial", "Multicenter Trials", "National Institute of Child Health and Human Development", "Participant", "Patients", "Pediatrics", "Principal Investigator", "Process", "Protocols documentation", "Public Health", "Records", "Registries", "Research", "Research Design", "Research Institute", "Research Methodology", "Research Personnel", "Research Support", "Resources", "Site", "Standardization", "Time", "Underserved Population", "United States", "United States National Institutes of Health", "Universities", "Vision", "Work", "biomedical informatics", "collaborative trial", "cost", "design", "electronic consent", "human subject", "improved", "innovation", "interoperability", "multi-site trial", "novel", "novel therapeutics", "operation", "programs", "recruit", "response", "stem", "success", "trial design", "web portal" ], "approved": true } }, { "type": "Grant", "id": "10524", "attributes": { "award_id": "75N95022C00032-0-9999-1", "title": "ACTIV-1 TIME-LIMITED BIOSPECIMEN STORAGE AND RELATED SERVICES (COVID-19), OPTION QUANTITY 1 STATISTICAL SUPPORT, OPTION QUANTITY 2 BIOSPECIMEN ANALYSI", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-22", "end_date": "2025-09-21", "award_amount": 2701936, "principal_investigator": { "id": 26532, "first_name": "SANDRA", "last_name": "BUTLER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1608, "ror": "", "name": "TECHNICAL RESOURCES INTERNATIONAL, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "CRO Assistance for Long-term Storage, Distribution and Analysis of Biospecimens from the ACTIV-1 Master Protocol, an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19.", "keywords": [ "Adult", "COVID-19", "Immunomodulators", "Pharmaceutical Preparations", "Phase III Clinical Trials", "Protocols documentation", "Safety", "Services", "Time" ], "approved": true } }, { "type": "Grant", "id": "12422", "attributes": { "award_id": "75N97023F00096-0-0-2", "title": "ACTIV TRACE support at NCBI for SARS-CoV-2", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2023-09-28", "end_date": "2028-09-27", "award_amount": 2354179, "principal_investigator": { "id": 28370, "first_name": "", "last_name": "", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2103, "ror": "", "name": "A-TEK", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "To monitor and evaluate SARS-CoV-2 genome evolution and characterize representative variant viruses for their potential impact on medical countermeasures.", "keywords": [ "2019-nCoV", "Basic Science", "Evolution", "Monitor", "SARS-CoV-2 genome", "Variant", "Virus", "medical countermeasure" ], "approved": true } }, { "type": "Grant", "id": "7529", "attributes": { "award_id": "3OT2HL156812-01S3", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 4000000, "principal_investigator": { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHand industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.", "keywords": [ "Address", "Adoption", "Area", "Behavior Therapy", "Biological", "Biometry", "Blood", "COVID-19", "COVID-19 pandemic", "Cardiovascular system", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Clinical Trials Network", "Collaborations", "Communication", "Complex", "Consensus", "Critical Care", "Data Collection", "Data Coordinating Center", "Development", "Devices", "Doctor of Philosophy", "Documentation", "Effectiveness", "Ensure", "Funding", "Goals", "Heart", "Human Resources", "Image", "Industry", "Informatics", "Information Dissemination", "Infrastructure", "Institutes", "International", "Intervention", "Knowledge", "Lead", "Leadership", "Lung", "Medical", "Medicine", "National Heart Lung and Blood Institute", "North Carolina", "Online Systems", "Operative Surgical Procedures", "Outcome", "Pharmaceutical Preparations", "Phase", "Principal Investigator", "Process", "Ramp", "Reporting", "Research", "Research Design", "Resources", "Role", "Running", "Scientist", "Site", "Speed", "Standardization", "Statistical Data Interpretation", "Technology", "Therapeutic", "Time", "United States National Institutes of Health", "Universities", "Validation", "clinical practice", "clinical research site", "data harmonization", "data quality", "data standards", "design", "experience", "flexibility", "informatics tool", "insight", "knowledge base", "operation", "professor", "programs", "protocol development", "sound", "targeted treatment", "therapy development" ], "approved": true } }, { "type": "Grant", "id": "7530", "attributes": { "award_id": "3OT2HL156812-01S4", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 17693191, "principal_investigator": { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHand industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.", "keywords": [ "Address", "Adoption", "Area", "Behavior Therapy", "Biological", "Biometry", "Blood", "COVID-19", "COVID-19 pandemic", "Cardiovascular system", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Clinical Trials Network", "Collaborations", "Communication", "Complex", "Consensus", "Critical Care", "Data Collection", "Data Coordinating Center", "Development", "Devices", "Doctor of Philosophy", "Documentation", "Effectiveness", "Ensure", "Funding", "Goals", "Heart", "Human Resources", "Image", "Industry", "Informatics", "Information Dissemination", "Infrastructure", "Institutes", "International", "Intervention", "Knowledge", "Lead", "Leadership", "Lung", "Medical", "Medicine", "National Heart Lung and Blood Institute", "North Carolina", "Online Systems", "Operative Surgical Procedures", "Outcome", "Pharmaceutical Preparations", "Phase", "Principal Investigator", "Process", "Ramp", "Reporting", "Research", "Research Design", "Resources", "Role", "Running", "Scientist", "Site", "Speed", "Standardization", "Statistical Data Interpretation", "Technology", "Therapeutic", "Time", "United States National Institutes of Health", "Universities", "Validation", "clinical practice", "clinical research site", "data harmonization", "data quality", "data standards", "design", "experience", "flexibility", "informatics tool", "insight", "knowledge base", "operation", "professor", "programs", "protocol development", "sound", "targeted treatment", "therapy development" ], "approved": true } }, { "type": "Grant", "id": "2616", "attributes": { "award_id": "3OT2HL156812-01SA", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 600000, "principal_investigator": { "id": 7613, "first_name": "Tracy L", "last_name": "Nolen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } }, { "type": "Grant", "id": "2619", "attributes": { "award_id": "3OT2HL156812-01SC", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 7622, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2023-05-31", "award_amount": 137000000, "principal_investigator": { "id": 7624, "first_name": "Tracy L", "last_name": "Nolen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 7625, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } }, { "type": "Grant", "id": "6977", "attributes": { "award_id": "3OT2HL156812-01S7", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Aging (NIA)" ], "program_reference_codes": [], "program_officials": [ { "id": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 1000000, "principal_investigator": { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIH- and industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.", "keywords": [ "Address", "Adoption", "Area", "Behavior Therapy", "Biological", "Biometry", "Blood", "COVID-19", "COVID-19 intervention", "COVID-19 pandemic", "COVID-19 treatment", "Cardiovascular system", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Clinical Trials Network", "Collaborations", "Communication", "Complex", "Consensus", "Critical Care", "Data Collection", "Data Coordinating Center", "Development", "Devices", "Doctor of Philosophy", "Documentation", "Effectiveness", "Ensure", "Funding", "Goals", "Heart", "Human Resources", "Image", "Industry", "Informatics", "Information Dissemination", "Infrastructure", "Institutes", "International", "Knowledge", "Lead", "Leadership", "Lung", "Medical", "Medicine", "National Heart Lung and Blood Institute", "North Carolina", "Online Systems", "Operative Surgical Procedures", "Outcome", "Pharmaceutical Preparations", "Phase", "Principal Investigator", "Process", "Ramp", "Reporting", "Research", "Research Design", "Resources", "Role", "Running", "Scientist", "Site", "Speed", "Standardization", "Statistical Data Interpretation", "Technology", "Therapeutic", "Time", "United States National Institutes of Health", "Universities", "Validation", "clinical practice", "clinical research site", "data harmonization", "data quality", "data standards", "design", "experience", "flexibility", "informatics tool", "insight", "knowledge base", "operation", "professor", "programs", "protocol development", "sound", "targeted treatment", "therapy development" ], "approved": true } }, { "type": "Grant", "id": "6138", "attributes": { "award_id": "3OT2HL156812-01S9", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Neurological Disorders and Stroke (NINDS)" ], "program_reference_codes": [], "program_officials": [ { "id": 20861, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 11150020, "principal_investigator": { "id": 20862, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 1384, "pages": 1442, "count": 14420 } } }