Division of Microbiology and Infectious Diseases (DMID)

NIAID Leadership Group for a Clinical Research Network on Antibacterial Resistance

New Funding Opportunity

NIAID plans to form a new Leadership Group that would develop and implement a comprehensive clinical research agenda to address antibacterial resistance. The plans to establish this new Leadership Group, and subsequent communications with the research community, are described in the Restructuring the NIAID Clinical Trials Network section. This new endeavor presents NIAID with an opportunity to leverage NIAID’s HIV/AIDS Clinical Trial Units and Clinical Research Sites to expand clinical research on non-HIV/AIDS infectious diseases. NIAID’s Division of Microbiology and Infectious Diseases (DMID) will oversee this new program. The funding opportunity announcement to form this new Leadership Group was published on January 13, 2012: Leadership Group for a Clinical Research Network on Antibacterial Resistance (RFA-AI-12-019); more information can be found at the Restructuring the NIAID Clinical Trials Network section. Investigators who may be interested in pursuing this new funding opportunity should be aware of the following information pertinent to this RFA.

Structure

This initiative will include support for the following components: scientific leadership and operations, network laboratories, and statistical and data management. Importantly, as noted above, the new Leadership Group will be responsible for developing and implementing a comprehensive clinical research agenda comprised of high priority clinical studies and trials focused on antibacterial resistance. In order to ensure that their application complements ongoing clinical research activities, potential applicants should be aware of pressing public health needs in the area of antimicrobial resistance, and relevant research supported by the government, including NIAID, and conducted by the research community (information about NIAID antibacterial resistance clinical research activities can be found on the NIAID antimicrobial (drug) resistance portal). These issues will be carefully considered as part of the NIH peer review process.

The majority of clinical studies and trials pursued by the Leadership Group will take place at NIAID-supported clinical trial sites, including the HIV/AIDS Clinical Trials Units and Clinical Research Sites and the Vaccine and Treatment Evaluation Units.

Available Resources and Requirements

In an effort to facilitate the efficient conduct of high quality clinical studies and trials, NIAID has centralized many of its clinical research resources and made them available to NIAID-supported clinical investigators.

In general, the studies and trials supported by NIAID fall into one of two categories—low resource, which require a low level of support services, or high resource, which require a high level of support services. The designated resource level determines the type of clinical services and support provided by NIAID and this determination is made in consultation with NIAID staff prior to study initiation.

High-resource trials generally include those that involve administration of an unapproved product, procedures that differ from standard of care, invasive procedures, or trials conducted under an Investigational New Drug (IND). For high-resource clinical trials conducted under the auspices of the Leadership Group, NIAID will provide support services including IND sponsorship, data management and statistical support, and clinical site monitoring; the specific clinical support services to be provided for each trial will be determined in consultation with NIAID staff.

High-resource clinical trials can include:

• Phase I, II, or III clinical trials of an unapproved product
• Phase I, II, or III clinical trials of an approved product for an unapproved indication, unless that indication is widely considered the standard of care
• A clinical trial that involves an invasive procedure coupled with product administration

An example of a high-resource clinical trial for antimicrobial resistance currently supported by NIAID: “Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia.”

All clinical studies and trials not designated as high-resource are considered low-resource. The Leadership Group must provide the statistical and data management support for low-resource studies and trials. NIAID will not provide clinical site monitoring for low-resource studies and trials. Low-resource clinical studies/trials can include:

• Clinical studies in which the only interventions are blood draws, small punch biopsies, and/or nasal swabs
• A clinical trial involving the administration of an approved product for an approved indication
• A clinical trial in which an approved product is administered per standard of care

An example of a low-resource clinical study/trial for antimicrobial resistance currently supported by NIAID: “Optimizing Dosing of Colistin for Infections Resistant to all Other Antibiotics.”

It is important to note that all NIAID-supported clinical investigators are required to develop clinical protocols and associated documents in accordance with standardized protocol development processes and templates. Clinical trials must be conducted in accordance with all federal regulations, NIAID Clinical Terms of Award, the International Conference on Harmonization ICH-E6-GCP guidelines and other applicable international guidelines.

NIAID's Antibacterial Resistance Research Activities

Examples of NIAID antibacterial resistance clinical research activities and information about NIAID's antimicrobial research program can be found on the antimicrobial (drug) web section. In addition, because there may be interest in the research community in forming partnerships to respond to this new RFA, investigators may request a comprehensive list of ongoing NIAID antibacterial resistance research activities by contacting April Hall at hallap@mail.nih.gov.

Contact

If you have questions, please contact Dr. Carolyn Deal, cdeal@niaid.nih.gov.