NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
ID: PAR-24-044Type: BOTH
Overview

Topic

NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: STTRPhase: BOTHYear: 2024
Timeline
  1. 1
    Release Nov 27, 2023 12:00 AM
  2. 2
    Open Dec 5, 2023 12:00 AM
  3. 3
    Next Submission Due Jan 5, 2024 12:00 AM
  4. 4
    Close Sep 6, 2026 12:00 AM
Description

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: link.

Files
No associated files provided.
Similar Opportunities
NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/pa-files/PAR-24-044.html).
NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required). This solicitation aims to support Small Business Concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require Federal regulatory approval or bring complex research tools to market. The solicitation is open until September 6, 2026, and more information can be found at the provided links.
NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) topic. This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The solicitation is open until September 6, 2026, and more information can be found at the provided links.
NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required). This solicitation encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. The program supports milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address high-priority research areas. The solicitation encourages high-risk clinical studies, which involve non-routine interventions, administration of unlicensed products, or administration of licensed products for unapproved indications. Mechanistic studies are also encouraged. The funding supports the conduct, completion, and analysis of a single clinical trial, including activities such as training of study personnel, enrollment and recruitment of study subjects, data collection and management, laboratory work, study management and oversight, safety monitoring, and regulatory activities. The project duration is not specified, but the solicitation is open until January 14, 2027. The funding specifics can be found on the grants.nih.gov website.
NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required). This solicitation encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. The program supports milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address high-priority research areas. The solicitation encourages high-risk clinical studies, which involve non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged. The funding supports the conduct, completion, and analysis of a single clinical trial, including activities such as training of study personnel, enrollment and recruitment of study subjects, data collection and management, laboratory work, safety monitoring, and regulatory activities. The project duration is not specified, but the application due dates are provided. More information can be found on the grants.gov website.