Working Group on New TB Drugs

Key Dates

Section I. Funding Opportunity Description

1.  Purpose

The purpose of this FOA is to solicit applications from domestic and foreign institutions to serve as Clinical Trials Units (CTUs) for NIAID clinical research networks focused on the following six research areas: 

1.  Adult HIV therapeutic strategies, including HIV cure, noninfectious comorbidities, and the infectious comorbidities of hepatitis and tuberculosis;

2.  Strategies to address HIV and HIV-associated infections in pediatric and maternal populations;

3.  Integrated HIV prevention strategies;

4.  Microbicide strategies to prevent HIV infection;

5.  Vaccines to prevent HIV infection; and

6.  Strategies to address antibacterial resistance. 

The establishment of a Clinical Research Network on Antibacterial Resistance presents a new opportunity for NIAID to leverage HIV/AIDS CTUs and Clinical Research Sites (CRSs) to expand clinical research on the pressing problem of antibacterial resistance. 

The development, implementation and adaptation, as needed, of the clinical research program of each clinical research network will be managed through separate awards to establish and maintain Leadership Groups (LGs).  The NIAID has previously solicited applications for Leadership Groups through separate FOAs.  Each Leadership Group (LG) will be comprised of a Leadership and Operations Center (LOC), a Laboratory Center (LC), and a Statistical and Data Management Center (SDMC).  The association of the CTUs and their CRSs along with the LG will constitute the clinical research network.  NIAID expects to fund a minimum of 25 CTUs in order to support the research agendas of the clinical research networks.

The CTU is the nucleus of clinical research activity for the clinical research networks. It is an organization/institution responsible for the coordination and execution of clinical trials in accordance with clinical research network, NIAID and other applicable policies. The CTU is composed of multiple components including:

1.  CTU administrative office

2.  At least one, but no more than eight (8) domestic or international CRS(s)

3.  Community Advisory Board(s) (CABs)

4.  Pharmacy(ies)

5.  Laboratory(ies)

6.  Other clinical research activities (including but not limited to data management, quality management, regulatory assurance and training)

The CTU provides the scientific and administrative expertise as well as the infrastructure to participate in two or more NIAID HIV/AIDS clinical research networks.  CTUs may also propose to be part of the Clinical Research Network on Antibacterial Resistance, but such affiliation is not required.  Each CTU must demonstrate sufficient breadth and depth of scientific expertise to contribute to the ongoing refinement of the clinical research network(s) agenda, participate in an array of scientific studies, and demonstrate a productive partnership with the community(ies) in which they propose to conduct research.  The CTU Administrative Office is responsible for managing all CTU resources and overseeing the performance of its associated components including CRS(s), local laboratory and pharmacy functions as defined below.  A CRS is a component of a CTU and is defined as a discrete location (e.g. hospital, outpatient clinic, community health center, private practice, local health department clinic) with appropriate, identified and characterized potential trial participants (e.g. demographics, incidence and prevalence of HIV/AIDS) where participant recruitment and retention, protocol management and other clinical research activities are conducted. 

A priority is placed on reaching populations severely impacted by the HIV/AIDS epidemic whose participation will help address priorities for NIAID HIV/AIDS research.  These populations include, but are not limited to women, adolescents and minorities in the United States as well as populations in low and middle-income countries. CTUs with the flexibility and capability to conduct multiple clinical research projects, the ability to respond rapidly to evolving research opportunities, and the capacity to participate in the development and implementation of the clinical research plans of multiple NIAID clinical research networks are particularly sought.  

Section II. Award Information

Key Dates