Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition: NCI National Clinical Trials Network - Network Group Statistics and Data Management Centers (U10 Clinical Trial Required)
Notice Number:
NOT-CA-24-084

Key Dates

Release Date:
July 22, 2024
Estimated Publication Date of Notice of Funding Opportunity :
September 25, 2024
First Estimated Application Due Date:
February 24, 2025
Earliest Estimated Award Date:
March 01, 2026
Earliest Estimated Start Date:
March 01, 2026
Related Announcements

None

Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) intends to issue a U10 NCI National Clinical Trials Network (NCTN) – Network Group Statistics and Data Management Center notice of funding opportunity (NOFO). The NCTN Network Group Statistics and Data Management Centers will provide statistical expertise for effective scientific design, conduct, and data management of clinical trials led by the associated NCTN Network Group Operations Center as well as for translational and other ancillary studies associated with the trials. The primary goal of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and advanced imaging trials across a broad range of cancers, modalities, and diverse patient populations as part of the NCI's overall clinical research program for adults, adolescents and young adults, and children with cancer. The NCTN also conducts, as necessary, preliminary studies needed for development of definitive trials, especially umbrella/basket trials and rare tumor trials, when an extensive, national patient catchment area is required.

This Notice of Intent to Publish is being provided to allow sufficient time for applicants to develop strong applications.
The NOFO is expected to be published in Fall 2024 with only one expected application due date in late February 2025.
 

Research Initiative Details

This Notice encourages investigators with expertise and experience related to the design, statistical analysis, and data management of cancer treatment clinical trials, especially late-phase randomized phase 2 and phase 3 trials to begin to consider applying for this NOFO. In addition, the investigators should also have expertise in trial monitoring to ensure appropriate trial conduct and outcomes validation and in data management processes and procedures for all phases of clinical trials to ensure serious adverse event reporting, timely trial completion, compliance, and data validity. The investigators statistical expertise should also extend to the appropriate design and analyses for translational and other ancillary studies that may be associated with the trials.  The funding provides support as well for participation in the collective management of the NCTN Program and facilitation of collaborations with other NCTN Groups, NCI-sponsored programs, and clinical trials organizations.

Funding Information

Estimated Total Funding

NCI intends to commit $47 million in FY 2026.

Expected Number of Awards

Five

Estimated Award Ceiling

Application budgets are not limited but need to reflect the actual needs of the proposed project. The total project period requested may not exceed 6 years.
 

Primary Assistance Listing Number(s)

93.394, 93.395

Anticipated Eligible Organizations


Only the current Network Statistics and Data Management Center awardees, currently supported under RFA-CA-17-057 are eligible to apply.

An organization applying for an NCI National Clinical Trials Network (NCTN) Group Operations Center Management Center award cannot apply for a Group Statistics and Data Management Center award under this FOA for the same project period.

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Margaret Mooney, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6006
Email: NCINCTNRFA@mail.nih.gov