Key Dates

Related Announcements

• October 9,2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Cancer Institute (NCI)

Purpose

Through this Notice of Special Interest (NOSI), the National Cancer Institute (NCI) announces an opportunity for administrative supplemental funding for current Cancer Screening Research Network (CSRN) cooperative agreement recipients including the CCC and ACCESS Hubs to support the Vanguard Study.

Background

In 2024 NCI launched the Cancer Screening Research Network (CSRN), a new network aimed to evaluate emerging technologies for cancer screening. As an initial effort, the CSRN has collaboratively developed a feasibility study, referred to as the Vanguard study, to inform the future design of a platform trial to evaluate Multi-Cancer Detection (MCD) tests for cancer screening in a flexible, but rigorous manner. The Vanguard study will enroll participants without cancer in one of 3 arms; a control arm, and two distinct MCD screening arms. All participants will receive blood draws upon enrollment, and at the one year follow up. Since the establishment of the Network, the Vanguard study design and objectives have evolved considerably compared to the preliminary design provided in the CSRN component RFAs. The level of study complexity has increased, and additional resources may be required for protocol execution. The CSRN maintains its commitment to accrual of diverse participants to clinical trials and additional resources may be required to develop successful recruitment strategies in the face of increased logistical challenges presented by the final Vanguard study design.  

Research Objectives

The NCI is providing this opportunity to support supplemental proposals to implement the Vanguard Study. The research solicited through this opportunity includes, but is not limited to augmentation of recruitment and retention activities, facilitation of study procedures, and performance and capture of participant diagnostic workup. 

Examples of the types of requests that may be supported through supplemental funding requested and obtained through this NOSI include, but are not limited to the following:

Recruitment and Retention

• Participant incentives and reimbursement for recruitment and retention;
• Personnel dedicated to participant recruitment; 
• Translation services/multilingual staff;
• Development of best practices related to recruitment and retention; 
• Tools for tracking site level recruitment monitoring; and
• Tools for tracking use of recruitment materials at site level and their impact on recruitment;  

Study Procedures

• Personnel dedicated to lab to perform blood draws or facilitate labeling after randomization;  
• Personnel to consent patients or answer questions;
• Personnel or resources allocated to communication with individuals with positive MCD tests;
• Costs related to specimen storage, shipping, or handling;
• Data entry personnel; and
• Data monitoring personnel.

Diagnostic Workup

• Imaging;
• Laboratory tests;
• Procedures ex biopsy, colonoscopy;
• Specialist visits;
• Personnel related to navigation of diagnostic workup; and
• Participant travel, or incentive to reduce burden of diagnostic workup.

Study Material Development and Trial Monitoring

• Website production and maintenance;
• Translation Services;
• Recruitment and Retention Monitoring;
• In person meeting planning costs; and
• Audit related costs.

Responsiveness

• Applications considered responsive must:
       1. Propose Vanguard Study-related work that was not included in the initial application, but within the scope of the original research project.     2. Provide a justification of Vanguard-related costs in reference to the final Vanguard design.
•  Applications will not be considered responsive if:
      1. Cancer treatment related costs are included in the research plan.
      2. Requests are duplicative of the parent award.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional).

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

Eligibility and Eligible Individuals (Program Director/Principal Investigator): 

• Only existing UG1 recipients of the Cancer Screening Research Network including the CCC and ACCESS Hubs.
       For supplements to parent awards that include multiple program directors/principal investigators (PDs/PIs), the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the recipient institution of the parent award.
• Requests for one year of support only.

Application Due Date:  Applications to this NOSI can be submitted on a rolling basis after the first available due date, December 12, 2024 until the expiration of this NOSI on January 30, 2025.

Budget 

• The budget should justify all the direct costs. Up to $350,000 in direct costs will be available for the supplement. 
• Requests must reflect the actual needs of the proposed project.
• Requests are permitted for one year of support only.
• Administrative supplements can be used to cover cost increases that are associated with implementing new Vanguard study design elements as long as the research objectives are within the original scope of the peer-reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project.
• The earliest anticipated start date is January 2, 2025.

Submitting Applications

• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the NOSI identified as NOT-CA-24-111.”
• For funding consideration, applicants must include “NOT-CA-24-111” (without quotation marks) in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.

Page limits: The Research Strategy section of the application is limited to 4 pages.

Review and Selection Process 
NCI will conduct administrative reviews of applications and will support meritorious applications submitted for consideration, based upon the availability of funds. Additionally, NCI program staff will evaluate applications using the following selection factors:

• Is the proposed work within the scope of the parent award, but beyond the original research plan?

All applicants are encouraged to discuss their applications with the scientific/research contact listed in this NOSI prior to submission.
 

Inquiries

Please direct all inquiries to:

Elyse LeeVan MD, MPH
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-7314
E-mail: elyse.leevan@nih.gov