NIH published this funding opportunity announcement (FOA) in a July 9, 2018 Guide announcement.
Table of Contents
Questions Published on July 9, 2018
- Scientific Focus and Structure
- What types of studies are permissible: only clinical trials or other types of clinical research as well?
- May the four centers of the Leadership Group (LG) be based at different institutions? If so, may each center have elements that are housed at different institutions? Under this scenario, how will indirect cost rates be calculated?
- Previous versions of the LG were required to use the Vaccine Treatment Evaluation Units (VTEUs) for “high resource” clinical trials. Is this still required?
- Are international sites allowed to be part of the group?
- Study and Trial Issues
- Must an application propose a clinical trial to be responsive to this FOA?
- For clinical studies and trials, what information should be provided in the body of the application?
- For clinical trials, can you clarify what the grantee will be expected to provide and what support services NIAID will provide?
- Who will decide whether proposed clinical trials should be conducted under IND/IDE?
- The FOA states that NIAID will be responsible for domestic regulatory filing. If other countries require regulatory or health authority filings, who will interact with those authorities?
- Whom do I contact for more information on this FOA?
Questions Published on July 9, 2018
Scientific Focus and Structure
The scope of the FOA covers all clinical research related to antibacterial resistance, spanning clinical studies and clinical trials. At least one immediate, delayed start, or delayed onset trial must be proposed. Also see the question Must an application propose a clinical trial to be responsive to this FOA? below.
May the four centers of the Leadership Group (LG) be based at different institutions? If so, may each center have elements that are housed at different institutions? Under this scenario, how will indirect cost rates be calculated?
Yes, the four centers (Scientific Leadership Center, Clinical Operations Center, Laboratory Center, and Statistics and Data Management Center) could each be based at a different institution.
The indirect cost rate for each center is the rate applicable at the institution where the activity is based.
Due to the diverse nature of LG studies and required patient populations, we expect that performance sites for implementing interventional clinical trials will be located at the applicants’ institution(s) or at directly subcontracted protocol-specific sites, managed by the Clinical Operations Center. However, applicants still have the option to use other NIAID clinical research sites, such as the VTEUs or the DAIDS Clinical Trials Units, on a case-by-case basis.
Yes, while an international investigator cannot be the lead principal investigator, the network structure may include international investigators and sites.
Study and Trial Issues
Clinical trials are required under the FOA; however, the applicant does not need to propose a trial at the time of application submission. The applicant must enter at least one immediate start, delayed start, or delayed onset study record into FORMS-E.
Note that for a delayed onset trial, limited information is required in FORMS-E. Read the November 1, 2017 NIAID Funding News article “Human Subjects: Delayed Start or Delayed Onset?”
Provide an outline of the initial project portfolio (clinical studies, clinical trials, and delayed onset studies and trials) as a part of the research agenda in the Scientific Leadership Center subsection of the application.
Include study records containing additional study information in FORMS-E following the general FORMS-E instructions and the FOA-specific instructions in section IV.2 PHS Human Subjects and Clinical Trials Information for all specific clinical studies and trials proposed in the application (immediate onset, delayed start, and/or delayed onset).
After award, NIAID staff will request a full protocol for each immediate-onset study included in the initial project portfolio. In addition, for each clinical trial (not delayed onset), NIAID staff will request updated information on the following:
- Project management and communication plans
- Composition of the study team, including roles and responsibilities
- Timelines and budgets
- Recruitment and Retention plan
NIAID will convene the safety oversight committee (Safety Monitoring Committee or Data and Safety Monitoring Board) and will conduct pharmacovigilance (Serious Adverse Event reporting) for all clinical trials the LG conducts.
For clinical trials requiring an Investigational New Drug (IND) or Device Exemption (IDE), NIAID will also provide support services including IND/IDE sponsorship, data management, management of clinical agents and specimens, and clinical site monitoring. For these trials, the LG is expected to provide the clinical sites and statistical leadership and analysis.
For clinical trials that do not require an IND/IDE, the LG will provide data management, management of clinical agents and specimens, and clinical site monitoring. For clinical studies, the LG will provide all necessary support services.
The specific clinical support services to be provided for each trial will be determined in consultation with NIAID Division of Microbiology and Infectious Diseases (DMID) staff. DMID reserves the right to modify these guidelines. Funds for services that NIAID provides should not be requested in the budget.
DMID will make that determination in consultation with the LG after it approves the study but before protocol development begins.
The grantee or appropriate subcontractor to the grantee will be responsible for fulfilling these obligations.
NIAID’s scientific/research contact for this opportunity is Dr. Jane Knisely.