Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU) Administrative Supplement (06/01/20-11/30/20) PROJECT SUMMARY The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); and adult HIV therapeutic strategies including HIV cure, management of non- infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU is comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women?s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly collaborative entity, which has centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions are driven by a rigorous evaluation process based on established metrics of performance and robust communication among leadership and staff of the CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a Research Pharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS, hepatitis C virus infection, and tuberculosis, and have well-grounded connections with the communities in which they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the conduct of studies which cross traditional network boundaries and that enables rapid responses to new scientific directions as they emerge. Under this Administrative Supplement application, The HBP CTU is responding to NIAID?s Notice of Special Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase understanding of and to establish treatments for COVID-19. The HBP CTU and its affiliated CRSs have well established and highly productive relationships with the NIAID- supported networks. Through its existing leadership and administrative structure, the HBP CTU is activated and prepared to immediately support these efforts. The HBP CTU is based in Boston, Massachusetts, which has been a ?hot spot? for SARS-CoV-2 infections and COVID-19 cases. The HBP CTU is well poised and experienced to support these emerging research needs and interests. In particular, HBP CTU is prepared to support and implement studies needed for expanded SAR-CoV-2 RNA and serology testing at our affiliated Clinical Research Sites (CRSs). The CTU is also prepared to rapidly implement other studies related to NIAID?s charge to address all aspects of SARS-CoV-2 and COVID-19 research, vaccine development and clinical trials, other prevention measures, and potential treatments. Studies at the CTU may include: seroepidemiology of SARS-CoV-2 in the Boston/New England area; treatment of COVID-19 with antivirals such as remdesivir and hydroxychloroquine; treament of advanced cases of COVID-19 with anti-IL-6 inhibitors; the conduct of clinical trials of candidate vaccines and mAbs for prevention and/or treatment of disease; and the development of in vitro assays used for making measurements of SARS-CoV-2 neutralization, which have the ability to distinguish incremental advances in potency, breadth, and durability. The HBP CTU administration will oversee the expansion and implementation of these activities at our affiliated CRSs and Clinical Research Laboratories (CRLs).
Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU) Administrative Supplement (06/01/20-11/30/20) PROJECT NARRATIVE The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); and adult HIV therapeutic strategies including HIV cure, management of non- infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU is comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women?s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly collaborative entity, which has centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions are driven by a rigorous evaluation process based on established metrics of performance and robust communication among leadership and staff of the CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a Research Pharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS, hepatitis C virus infection, and tuberculosis, and have well-grounded connections with the communities in which they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the conduct of studies which cross traditional network boundaries and that enables rapid responses to new scientific directions as they emerge. Under this Administrative Supplement application, The HBP CTU is responding to NIAID?s Notice of Special Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase understanding of and to establish treatments for COVID-19. The HBP CTU and its affiliated CRSs have well established and highly productive relationships with the NIAID- supported networks. Through its existing leadership and administrative structure, the HBP CTU is activated and prepared to immediately support these efforts. The HBP CTU is based in Boston, Massachusetts, which has been a ?hot spot? for SARS-CoV-2 infections and COVID-19 cases. The HBP CTU is well poised and experienced to support these emerging research needs and interests. In particular, HBP CTU is prepared to support and implement studies needed for expanded SAR-CoV-2 RNA and serology testing at our affiliated Clinical Research Sites (CRSs). The CTU is also prepared to rapidly implement other studies related to NIAID?s charge to address all aspects of SARS-CoV-2 and COVID-19 research, vaccine development and clinical trials, other prevention measures, and potential treatments. Studies at the CTU may include: seroepidemiology of SARS-CoV-2 in the Boston/New England area; treatment of COVID-19 with antivirals such as remdesivir and hydroxychloroquine; treament of advanced cases of COVID-19 with anti-IL-6 inhibitors; the conduct of clinical trials of candidate vaccines and mAbs for prevention and/or treatment of disease; and the development of in vitro assays used for making measurements of SARS-CoV-2 neutralization, which have the ability to distinguish incremental advances in potency, breadth, and durability. The HBP CTU administration will oversee the expansion and implementation of these activities at our affiliated CRSs and Clinical Research Laboratories (CRLs).
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