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Grant Analysis

Purpose & Target

This grant aims to support clinical studies that integrate imaging and fluid-based tumor monitoring (liquid biopsy) assays during cancer therapy. The goal is to determine the optimal use of these combined modalities for characterizing therapy response and identifying treatment resistance.
Target recipients include researchers, clinical scientists, and institutions from various sectors, including higher education, nonprofits, for-profits, and government entities.
This is a SECTOR-SPECIFIC grant, focused on the healthcare industry, specifically cancer research and therapy.
Geographic scope is limited to the U.S. and its territories.
Key filtering criteria: This grant specifically targets clinical studies utilizing already developed and validated imaging and liquid biopsy methods, not the development of new technologies or early cancer detection/curative surveillance.
This is a recurring grant opportunity with multiple application due dates over several years, re-issued from a previous program announcement.

Financial Structure

Application budgets are limited to less than $500,000 in direct costs per year.
The maximum project period is 5 years.
The maximum potential direct costs for a 5-year project would be $2,500,000.
This funding opportunity does NOT require cost sharing or matching funds.
Pre-award costs are only allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Financial reporting requirements include submission of annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout.
Awards are subject to the terms and conditions, cost principles, and audit requirements described in 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Eligibility Requirements

Organizational Requirements

Eligible Entities:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with 501(c)(3) IRS Status or without)
For-Profit Organizations (including Small Businesses and Other For-Profits)
Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other)
Federal Governments (Eligible Agencies of the Federal Government)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations)
Geographic Restrictions:
Non-domestic (non-U.S.) entities are NOT eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are NOT eligible to apply.
Foreign components, as defined by NIH, are allowed within a U.S. organization's project.
Registration:
Must complete and maintain active registrations with System for Award Management (SAM) (requires annual renewal), Unique Entity Identifier (UEI), eRA Commons (for organization and PD/PI), and Grants.gov. Registrations can take 6 weeks or more.

Project/Technical Requirements

Research Focus: Proposed projects must integrate already developed and validated (or in final validation) imaging and fluid-based tumor monitoring assays into clinical studies.
Project Scope: Funding supports clinical studies assessing treatment success, failure, or recurrence in one or more therapeutic settings.
Appropriate settings include: clinical trials during active treatment for cancer recurrence, first-line therapy for aggressive/advanced disease, and retrospective data collection/analysis from current studies.
Exclusion Criteria (Non-responsive applications):
Long-term post-treatment surveillance in patients where treatment has been curative.
Early detection in screening settings.
Pre-clinical development and testing of imaging agents/modalities or fluid-based tumor monitoring (liquid biopsy) assays.
Development of novel imaging or liquid biopsy methods or platforms.
Clinical Trial Option: Accepting applications that either propose or do not propose clinical trial(s). If proposing a clinical trial, FDA IND/IDE (if applicable) must be demonstrated.

Principal Investigator (PD/PI) Requirements

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research.
Must have an eRA Commons account affiliated with the applicant organization.

Application Process

Submission Methods:
NIH ASSIST system (online preparation, submission, tracking)
Institutional system-to-system (S2S) solution
Grants.gov Workspace (preparation, submission)
Letter of Intent (LOI):
Not required or binding, but encouraged 30 days prior to the application due date.
LOI should include: Descriptive title of proposed activity, PD(s)/PI(s) name(s), address(es), and telephone number(s), names of other key personnel, participating institution(s), and the funding opportunity number and title.
Send LOI to: Yisong Wang, Ph.D. (National Cancer Institute, email: [email protected], phone: 240-620-0690).
Instructions: Applicants must follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO. Non-compliance may lead to delays or non-acceptance.
Page Limitations: All page limitations described in the 'How to Apply- Application Guide' and 'Table of Page Limits' must be followed.
Required Documentation/Sections: Standard NIH forms including SF424(R&R) series, R&R/Modular Budget, PHS 398 series (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information), and PHS Assignment Request Form.
Research Strategy Specifics:
Justify the choice of patient population and provide evidence of its availability.
Demonstrate FDA IND/IDE (if applicable) for imaging methods or fluid-based assays.
Provide rigorous statistical and power analyses to assure clinical meaningfulness.
Include letters of support from clinical partners or collaborators.
Data Management and Sharing Plan: Required for all applications generating scientific data.
Appendix: Only limited materials allowed (e.g., blank questionnaires; no publications).

Submission and Review Timeline

Open Date (Earliest Submission): January 05, 2025.
Application Due Dates: Applications are due by 5:00 PM local time of the applicant organization. Multiple standard NIH due dates are available. The latest due date for any application type (including AIDS-related) is January 07, 2028.
Expiration Date: January 08, 2028.
Review and Award Cycles (for latest deadline):
Scientific Merit Review: March 2028
Advisory Council Review: May 2028
Earliest Start Date: July 2028
Applicants are encouraged to submit early to allow time for corrections.

Post-Award Requirements

Reporting: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements.
Closeout: A final RPPR, invention statement, and expenditure data are required for award closeout.
ClinicalTrials.gov: If the award includes a clinical trial, the responsible party must register and submit results to ClinicalTrials.gov.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Required for human biomedical and behavioral intervention studies.
FDA IND/IDE: Clinical research involving investigational therapeutics or devices must be performed under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).

Evaluation Criteria

Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s).

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
Factor 2: Rigor and Feasibility (Approach)
Clinical trial proposals must justify patient population, provide evidence of available patient population and clinical trial, demonstrate FDA IND/IDE (if applicable), ensure data completion within the 5-year funding timeframe, and include rigorous statistical/power analyses for clinical meaningfulness.
Factor 3: Expertise and Resources (Investigator(s) and Environment)

Additional Review Criteria (Not scored, but considered for Overall Impact)

Protections for Human Subjects
Vertebrate Animals (if applicable)
Biohazards (adequacy of proposed protection)
Resubmissions (evaluation of the full, updated application)

Additional Review Considerations (Not scored)

Authentication of Key Biological and/or Chemical Resources (plans for identifying and ensuring validity)
Budget and Period of Support (justification and reasonableness in relation to proposed research)

Compliance & Special Requirements

Regulatory Compliance

General: All awards are subject to the terms and conditions, cost principles, and regulations described in the NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, Audit Requirements for Federal Awards).
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws, which is agreed to upon SAM.gov registration.
Mandatory Disclosure: Recipients are required to disclose any violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.
Human Subjects/Clinical Trials: Strict adherence to federal regulations regarding human subjects research, including IRB/IEC approval, data and safety monitoring, and FDA IND/IDE requirements if applicable.

Data Management & Sharing

NIH Policy: Consistent with the 2023 NIH Policy for Data Management and Sharing, recipients generating scientific data must submit and implement a Data Management and Sharing Plan.

Risk Management and Security

Biohazards: Proposed research involving biohazards must demonstrate adequate protection for research personnel and the environment.
System Issues: Applicants must follow NIH guidance for 'Dealing with System Issues' if technical problems threaten on-time application submission.

Unique Aspects

Emphasis on Collaboration: This NOFO specifically promotes collaboration among imaging scientists, fluid-based assay developers, and clinical scientists.
Clinical Utility: The core objective is to determine the precise clinical utility and added value of combining imaging and liquid biopsy assays in cancer treatment monitoring.
Focus on Existing Technologies: Crucially, this grant is for studies using already developed and validated (or in final validation) imaging and liquid biopsy methods, rather than the development of novel technologies. This is a key distinction for potential applicants.

Grant Details