Grant name: NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Funding organization: National Institutes of Health (NIH)
Total funding amount: Up to $450,000 in direct costs over a three-year period
Duration: Maximum project period of 3 years
Primary objective: To support studies that inform the planning of Phase II-IV clinical trials for heart, lung, blood, and sleep disorders.
Key stakeholders: NIH, NHLBI, research institutions, and clinical trial participants.
Beneficiaries: Patients with heart, lung, blood, and sleep disorders.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments.
Specific qualifications include having the necessary skills, knowledge, and resources to carry out the proposed research.
Organizations must complete required registrations such as SAM and eRA Commons prior to application submission.
Eligible applicants must be based in the U.S. or have U.S. components.
Non-domestic (non-U.S.) entities are not eligible to apply, but foreign components of U.S. organizations are allowed.
Projects must focus on heart, lung, blood, or sleep disorders.
Research must be scientifically necessary to design or plan a subsequent clinical trial.
Applications must not propose first-in-human studies or purely mechanistic studies.
Application budgets may request up to $450,000 in direct costs over a three-year period.
No cost-sharing is required.
Application due date: January 7, 2027.
Open date for applications: January 16, 2025.
Letter of intent due 30 days before application due date.
Applicants may submit more than one application if each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications under review at the same time.
Applications must include a Future Clinical Trial Description and FDA Approval documentation if applicable.
All required registrations must be completed before submission.
Applications will be evaluated based on scientific merit, including significance, innovation, rigor, and feasibility.
Reviewers will provide an overall impact score reflecting the likelihood of the project to influence the research field.
Applications will undergo peer review by appropriate Scientific Review Groups.
Only applications deemed to have the highest scientific merit will be discussed.
The grant supports pilot studies that yield information necessary for planning future clinical trials.
Applications involving FDA-regulated products must secure IND or IDE approval before funding decisions.
Applicants must ensure compliance with all application instructions to avoid delays or rejection.
Registration processes can take significant time, and applicants should begin early.
Demonstrating the scientific necessity of the proposed research is crucial.
Clear articulation of how the pilot study will inform future clinical trials is essential.
Avoid submitting overlapping applications.
Ensure all required documents are included to prevent application incompleteness.