Grant List
Represents Grant table in the DB
GET /v1/grants?sort=-award_amount
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-award_amount", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1392&sort=-award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-award_amount", "prev": null }, "data": [ { "type": "Grant", "id": "3492", "attributes": { "award_id": "1OT2HL161847-01", "title": "OTA-21-015A Post-Acute Sequelae of SARS-CoV-2 Infection Initiative: NYU Langone Health Clinical Science Core, Data Resource Core, and PASC Biorepository Core", "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": 11236, "first_name": "Michelle", "last_name": "Olive", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-05-24", "end_date": "2023-05-23", "award_amount": 448283318, "principal_investigator": { "id": 11237, "first_name": "Rachel Sharon", "last_name": "Gross", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 11238, "first_name": "Leora", "last_name": "Horwitz", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 11239, "first_name": "STUART D", "last_name": "KATZ", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 11240, "first_name": "Andrea B", "last_name": "Troxel", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 832, "ror": "", "name": "NEW YORK UNIVERSITY SCHOOL OF MEDICINE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } }, { "type": "Grant", "id": "7802", "attributes": { "award_id": "3UM1AI068614-14S1", "title": "HVTN 405/HPTN 1901 Characterizing SARS-CoV-2-specific immunity in convalescent individuals", "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": 6245, "first_name": "Philip O.", "last_name": "Renzullo", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-07-02", "end_date": "2022-11-30", "award_amount": 393953893, "principal_investigator": { "id": 6247, "first_name": "Lawrence", "last_name": "Corey", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 757, "ror": "", "name": "FRED HUTCHINSON CANCER RESEARCH CENTER", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 6248, "first_name": "Glenda E", "last_name": "Gray", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 757, "ror": "", "name": "FRED HUTCHINSON CANCER RESEARCH CENTER", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "This proposal outlines the scientific agenda for the Leadership and Operations Center of the HIV Vaccine Trials Network (HVTN), the collaboration of physician scientists at 64 clinical trial sites in 15 countries on 4 continents dedicated to developing globally effective vaccines for HIV, tuberculosis and now SARS-CoV-2. The HVTN has led HIV prevention science for over 20 years through robust phase 1 and 2 clinical development trials and currently has 2 vector based vaccines (ALVAC and Ad26) and 1 broadly neutralizing monoclonal antibody (mAb) VRC01 undergoing testing in 5 randomized controlled efficacy trials. With the rapid onset of the COVID-19 pandemic, we recognize there is a significant gap in knowledge in the field on the contribution of immune functions involved in preventing infection, in modifying COVID-19 disease, and in clearing viral infection. We believe the HVTN is well placed to study these gaps and rapidly deploy this information in the development of SARS-CoV-2 neutralizing vaccines and mAb therapies. In this study we propose initiating an observational cohort study of approximately 400 persons in the United States (22 trials sites) and Peru (5 sites) convalescing from SARS-CoV-2 infection. Participants will be recruited from a variety of risk groups and clinical cohorts: hospitalized vs. non-hospitalized, symptomatic vs. asymptomatic, adults between 18 and 55 years of age and those older than 55 years, and persons with high interest clinical or virologic presentations (eg, persons who developed myocarditis/pericarditis, required intubation, had prolonged viral shedding, or who develop a positive virologic test after initially clearing the infection). Specific aims of this study include identifying serologic reactivities that differentiate SARS-CoV-2 infection from vaccination, to develop and qualify a suite of immunologic assays and reference reagents that will permit detailed interrogations of the immune response to infection, to measure SARS-CoV-2 adaptive response in key populations and risk groups, and to characterize presentations of the infection among convalescent individuals. This initial study will tell us much about the adaptive immune responses in persons who have been infected and recovered from SARS-CoV-2 and will shed light on the role the immune system plays in successfully clearance of infection. It will improve our understanding of the dynamics and duration of responses, as well as the epitope specificity and other defining signatures, and will inform rational design and testing of preventive and therapeutic vaccines and monoclonal antibodies. In addition, this protocol will lay the groundwork for prospective studies of this infection, better defining key risk groups and knowledge gaps. Lastly, this study will prepare the network for the large number of COVID-19 vaccines now entering the clinical trial pipeline. Laboratory, statistical and operational experience in this first trial will be invaluable preparation and priming of network machinery as the HVTN prepare to roll-out several efficacy trials as part of the joint NIAID COVID Prevention Network in coming months.", "keywords": [ "2019-nCoV", "AIDS prevention", "ALVAC", "Acute", "Adult", "Age-Years", "Biological Assay", "Biometry", "COVID-19", "COVID-19 pandemic", "COVID-19 vaccine", "Cells", "Cellular Assay", "Chronic", "Clinical", "Clinical Trials", "Cohort Studies", "Collaborations", "Communicable Diseases", "Country", "Development", "Disease", "Disease Outbreaks", "Epitopes", "Eye", "Future", "Goals", "HIV Vaccine Trials Network", "HIV vaccine", "HIV/TB", "Health", "Immune", "Immune response", "Immune system", "Immunity", "Immunologic Markers", "Immunologics", "Immunology", "Immunology procedure", "Immunotherapeutic agent", "Individual", "Infection", "Infection Control", "Infection prevention", "Inflammation", "Intubation", "Joints", "Knowledge", "Laboratories", "Lead", "Leadership", "Light", "Malaria", "Measures", "Mediating", "Medical", "Medical History", "Monoclonal Antibodies", "Monoclonal Antibody Therapy", "Morbidity - disease rate", "Myocarditis", "National Institute of Allergy and Infectious Disease", "Participant", "Pathologic", "Pericarditis", "Persons", "Peru", "Pharmaceutical Preparations", "Phase", "Physicians", "Play", "Population", "Preparation", "Prevention", "Preventive vaccine", "Prospective Studies", "Protocols documentation", "Quality Control", "Randomized", "Randomized Clinical Trials", "Reagent", "Research Methodology", "Risk", "Role", "Sampling", "Science", "Scientist", "Series", "Serological", "Severity of illness", "Site", "Specificity", "System", "Testing", "Typhoid Fever", "United States", "Vaccination", "Vaccines", "Validation", "Virus", "Virus Diseases", "Virus Shedding", "adaptive immune response", "clinical development", "clinical trial analysis", "cohort", "coronavirus disease", "design", "efficacy study", "efficacy trial", "experience", "illness length", "immune function", "improved", "interest", "mortality", "neutralizing monoclonal antibodies", "neutralizing vaccine", "operation", "pandemic disease", "prevent", "programs", "quality assurance", "recruit", "response", "therapeutic vaccine", "vaccine trial", "vector-based vaccine", "virology" ], "approved": true } }, { "type": "Grant", "id": "9191", "attributes": { "award_id": "272201700078C-P00013-9999-2", "title": "COVID-19: NIAID Clinical Research Support Services (CRSS)", "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": "2020-08-15", "end_date": "2021-06-30", "award_amount": 385065810, "principal_investigator": { "id": 24945, "first_name": "BAMBRA", "last_name": "STROKES", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The purpose of this contract is to provide a broad range of research support services to the current and evolving NIAID-supported clinical research portfolio. The contract enables the NIAID to establish and maintain the robust and flexible resources required to facilitate and advance infectious disease research and establish and maintain support for product development activities for high priority vaccine, other prevention and therapeutic approaches. Support will be provided in four broad clinical research areas: a) clinical research management; b) clinical site assistance; c) clinical trial management and d) clinical trial compliance. This project will provide support services for the COVID-19 ACTIV2 Outpatient Monoclonal Antibodies And Other Therapies clinical trial.", "keywords": [ "Area", "COVID-19", "Clinical Data", "Clinical Research", "Clinical Trials", "Contracts", "Diagnosis", "Diagnostic", "Disease", "Immune", "Immunology", "Infectious Diseases Research", "Laboratories", "Mediating", "Medical", "Microbiology", "Monitor", "Monoclonal Antibodies", "National Institute of Allergy and Infectious Disease", "Outpatients", "Prevention", "Reporting", "Research Support", "Resources", "Service provision", "Services", "Therapeutic", "Therapy Clinical Trials", "United States Dept. of Health and Human Services", "United States National Institutes of Health", "Vaccines", "Writing", "clinical research site", "data management", "flexibility", "product development", "quality assurance", "vaccine development" ], "approved": true } }, { "type": "Grant", "id": "11906", "attributes": { "award_id": "75N91019D00024-0-759102300008-1", "title": "PHASE 1 AND PHASE 2 CLINICAL TRIALS FOR NEXT-GENERATION CORONAVIRUS VACCINES", "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": "2023-06-01", "end_date": "2028-05-31", "award_amount": 277585346, "principal_investigator": { "id": 27808, "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": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } }, { "type": "Grant", "id": "7812", "attributes": { "award_id": "3UM1AI068636-14S2", "title": "Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/", "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": 21580, "first_name": "Akinlolu O", "last_name": "Ojumu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-24", "end_date": "2020-11-30", "award_amount": 181942638, "principal_investigator": { "id": 21581, "first_name": "Judith S.", "last_name": "Currier", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 21582, "first_name": "Joseph J", "last_name": "Eron", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "To more safely and efficiently treat COVID-19 participants, we request support to place COVID-19 Isolation PODS at 14 of the ACTG CRSs. The storage company, PODS, has developed stand-alone and CDC compliant units. Installation of a COVID-19 POD at CRS locations will primarily facilitate A5401 but also protocol A5395. These units additionally allow separation between these activities and our HIV patients for both COVID treatment and prevention studies. A5401 will study up to 10 different agents across phase 2 and phase 3 trials. This dedicated space will allow for efficient treatment of a high volume of study participants without comprising infection control measures of the general clinic population.", "keywords": [ "AIDS clinical trial group", "COVID-19", "Centers for Disease Control and Prevention (U.S.)", "Clinic", "Clinical Trials Cooperative Group", "Enrollment", "HIV", "Infection Control", "Leadership", "Location", "Measures", "Participant", "Patients", "Phase", "Population", "Prevention", "Protocols documentation", "clinical research site", "coronavirus disease", "operation", "phase III trial", "prevention clinical trial" ], "approved": true } }, { "type": "Grant", "id": "7789", "attributes": { "award_id": "3UM1AI068619-14S1", "title": "CoVPN Vaccine Site Preparation", "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": 23281, "first_name": "Cherlynn", "last_name": "Mathias", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-07-14", "end_date": "2020-11-30", "award_amount": 169587659, "principal_investigator": { "id": 23599, "first_name": "MYRON S.", "last_name": "COHEN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1623, "ror": "", "name": "FAMILY HEALTH INTERNATIONAL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23600, "first_name": "WAFAA M.", "last_name": "EL-SADR", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 781, "ror": "", "name": "COLUMBIA UNIVERSITY HEALTH SCIENCES", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 1623, "ror": "", "name": "FAMILY HEALTH INTERNATIONAL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Given the rapid spread of SARS-CoV-2 infection, the on-going global pandemic, and the risk for seasonal recurrence there is a critical need to test emerging vaccine candidates in phase 3 efficacy trials. Due to its experience in implementation of global HIVAIDS prevention efficacy trials and its operational capacity to respond to a new global pandemic, the HPTN, in collaboration with the HVTN, is providing operational support for the newly constituted COVID-19 Prevention Network (CoVPN). Preparing for a series of large scale efficacy trials, this application outlines aims required to build the infrastructure capacity to rapidly implement them over the coming month. The requested funds are to prepare clinical trial sites for implementation of these trials. The HPTN will support 30 clinical trials sites in the United States, South America, and Sub-Saharan Africa so they can begin enrollment in NIH supported COVID-19 vaccine and monoclonal trials planned for implementation over the next 6 months.", "keywords": [ "2019-nCoV", "Administrative Supplement", "Africa South of the Sahara", "COVID-19", "COVID-19 vaccine", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Collaborations", "Diagnostic", "Disease", "Disease Management", "Disease Outbreaks", "Drug Industry", "Enrollment", "Ethics", "Funding", "HIV Vaccine Trials Network", "Infection", "Infrastructure", "International", "Measures", "Monitor", "Monoclonal Antibodies", "Phase", "Population", "Preparation", "Prevention", "Public Health", "Recurrence", "Request for Applications", "Risk", "Series", "Site", "South America", "Testing", "Time", "United States", "United States National Institutes of Health", "Vaccines", "Work", "clinical infrastructure", "clinical research site", "cost", "efficacy trial", "experience", "health economics", "high risk", "human subject protection", "implementation trial", "pandemic disease", "prevent", "prevention efficacy trial", "response", "vaccine candidate" ], "approved": true } }, { "type": "Grant", "id": "9103", "attributes": { "award_id": "3OT2HL156812-01S2", "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 Heart Lung and Blood Institute (NHLBI)" ], "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": "2021-05-31", "award_amount": 169000000, "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": "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": "9100", "attributes": { "award_id": "3OT2HL156812-01S6", "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 Heart Lung and Blood Institute (NHLBI)" ], "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": 126725997, "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": "3172", "attributes": { "award_id": "1OT2HL161841-01", "title": "Interactive Data Portals and Robust Analytic Tools to Wrap PASC Cohorts (iDRAW) OTA-21-015A", "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": 9908, "first_name": "RAY F", "last_name": "EBERT", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-06-10", "end_date": "2023-06-09", "award_amount": 99738402, "principal_investigator": { "id": 9909, "first_name": "Andrea S", "last_name": "Foulkes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 9910, "first_name": "ELIZABETH W", "last_name": "KARLSON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 9911, "first_name": "SHAWN N", "last_name": "MURPHY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 736, "ror": "https://ror.org/002pd6e78", "name": "Massachusetts General Hospital", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 1, "pages": 1392, "count": 13920 } } }