NIAID has a robust suite of funding opportunities and resources to facilitate investigator-initiated clinical trials (IICTs), which are indexed and described at Investigator-Initiated Clinical Trial Resources. Notably, we maintain a consultation process designed to help potential applicants identify an appropriate notice of funding opportunity (NOFO), assess readiness to apply, consider risk level, identify supplemental resources, and collect needed pre-application approvals.
Last week, we reissued two of those NOFOs:
- NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required)
- NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)
The U01 NOFO is designed for high-risk trials, i.e., the study will provide a non-routine intervention, administer an unlicensed product, or use a licensed product for an unapproved indication. The U44 NOFO is the only IICT initiative through which small business concerns may apply.
Cooperative Agreement IICT U01 NOFO
This NOFO encourages applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.
The proposed trial must be hypothesis-driven, related to NIAID’s research mission, and address a research area considered a high priority by the Institute. For HIV-related clinical trials, NIAID encourages projects that integrate biomedical and behavioral interventions as well as studies that explore pathogenesis of HIV infection.
Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial. Investigators are also encouraged to visit NIAID Role in Research for additional information about our research mission and high-priority research areas.
Changes in the Reissued U01 NOFO
First, NIAID is allowing for the submission of platform trials. A platform trial is a type of clinical trial that allows for simultaneous comparison of multiple interventions against a single control group.
While platform trials predate the COVID-19 pandemic, the pandemic had increased use of these trials and demonstrated their potential to expeditiously evaluate multiple putative therapeutics. Some platform trials have been implemented without a total enrollment or all interventions worked out at the beginning.
These open-ended trials are difficult for NIAID to budget and difficult for peer review to assess. Thus, the IICT U01 NOFO clarifies that an application with a single platform trial is permitted, but the application must include sufficient detail about the platform design and planned interventions so that peer reviewers and NIAID staff can assess the totality of the planned trial.
Second, submission of renewal applications is now allowed, albeit with strong rationale. To that end, we strongly encourage you to arrange for prior consultation with NIAID program staff before submitting a renewal application.
Third, for a budget that is equal to or greater than $1,000,000 in direct costs in any year of the proposed trial, prior consultation with NIAID staff is strongly encouraged at a minimum of 12 weeks before submitting the application. Prior consultation with NIAID staff is required 10 weeks before application submission if the budget is equal to or greater than $500,000 in direct costs for any 1 year of the proposed trial.
The additional 2 weeks for budgets equal to or greater than $1,000,000 in direct costs is necessary to allow for additional internal reviews at NIAID.
If you have questions, direct them to the appropriate NIAID scientific research contact:
- Division of AIDS—Martin Gutierrez at mgutierrez@niaid.nih.gov or 240-292-4844
- Division of Allergy, Immunology, and Transplantation—Dr. Ellen Goldmuntz at egoldmuntz@niaid.nih.gov or 240-627-3502
- Division of Microbiology and Infectious Diseases (DMID)—DMID IICT Central Contact Mailbox at NIAID_DMID_IICT@niaid.nih.gov
For concerns related to peer review, reach out to NIAID’s peer review contact Dr. Louis Rosenthal at louis.rosenthal@nih.gov or 240-669-5070.
SBIR Phase II IICT U44 NOFO
This NOFO encourages small business innovation research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials.
Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and may be proposed under this program.
This NOFO will support the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial, such as:
- Training of study personnel
- Enrollment and recruitment of study subjects
- Costs associated with investigational products
- Data collection, management, and quality control
Read the NOFO for additional examples.
Note that all clinical trial planning activities must be completed prior to application submission and all requisite documentation needs to be provided for an application to be considered complete for a Phase II award (except for Fast Track applications).
Refer to Rules and Policies for Clinical Research for protocol templates and guidance, clinical research resources, and links to other program division resources.
Investigators are strongly encouraged to contact NIAID’s scientific/research contact Dr. Natalia Kruchinin at NIAIDU44@mail.nih.gov or 240-669-2919 for information regarding division-specific clinical research policies and procedures. For matters related to peer review, reach out to NIAID’s peer review contact Dr. Louis Rosenthal at louis.rosenthal@nih.gov or 240-669-5070.