The University of Rochester (UR) Infectious Diseases Division (IDD) has meaningfully contributed to the NIAID HIV/AIDS Clinical Research Networks (CRNs) for over 30 years. The enduring mission of the UR Clinical Trials Unit (CTU) is to support and conduct clinical research on HIV/AIDS that contributes to the discovery of a preventive vaccine for HIV, as well as to the discovery of a cure for HIV, and of treatments that reduce the burden of disease due to HIV infection and its complications. It will acheive this mission by providing exceptional scientific and administrative leadership, and outstanding clinical trials infrastructure, and by engaging with all relevant stakeholders and communities, to ensure that the research it conducts is responsive to community needs.
Five aims are proposed. The first is to strengthen our well-established Clinical Research Sites (CRSs). To do this, we will support 2 domestic CRSs that will participate in the following NIAID CRNs: (i) the `AIDS Clinical Trials Group' (ACTG); and (ii) the `HIV Vaccine Trials Network' (HVTN). We will also develop a plan to diversify UR CTU leadership, and to enhance integration and coordination of these CRSs.
The second aim i s to provide exceptional administrative leadership that accelerates and enhances NIAID clinical research. We will do this by continuing and enhancing effective financial management procedures and a robust quality management program, and by continuously assessing well-defined metrics of operational performance and capacity; these measures will be used to determine improvement opportunities that will be addressed by targeted actions and follow-up evaluation to assess the efficacy of such interventions. Performance data will be coupled to resource allocation, and poorly performing CTU components will be terminated, if necessary.
The third aim i s to provide exceptional scientific leadership that promotes important contributions to the advancement of HIV/AIDS science, and mentors the next generation of CTU researchers. The CTU will oversee and coordinate groundbreaking research activities at the participating CRSs, develop and execute a strong research agenda for the ACTG and HVTN, mentor and train the next generation of CTU researchers, and draw upon campus-wide intellectual capital.
Aim four will provide outstanding clinical trials infrastructure, including data and quality management, regulatory support, laboratory, pharmacy and other resources. Innovations will include procedures that facilitate flexibility and surge capacity, allowing a rapid response to emerging Network needs, as well as shared resources that promote cost efficiency. Finally, our fifth aim is to communicate and engage effectively with all UR CTU stakeholders. The Rochester Community Advisory Board (CAB) and our diverse Community Education and Recruitment (CER) Team will engage with local communities, to increase community awareness and education, and facilitate recruitment and retention of research participants. Finally, we will also continue highly responsive communication and engagement with NIAID, its CRNs, and all other key constituencies.

Public Health Relevance

The enduring mission of the University of Rochester (UR) Clinical Trials Unit (CTU) is to support and conduct clinical research on HIV/AIDS that contributes to the discovery of a preventive vaccine for HIV, as well as to the discovery of a cure for HIV, and of treatments that reduce the burden of disease due to HIV infection and its complications. The UR CTU will acheive this mission by providing exceptional scientific and administrative leadership, together with outstanding clinical trials infrastructure. It will also engage with the communities that it serves, thereby ensuring that the research it conducts is responsive to community needs.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069511-15
Application #
10057897
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Pouliot, Eileen M
Project Start
2007-02-01
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
University of Rochester
Department
Internal Medicine/Medicine
Type
School of Medicine & Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
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