Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition: NCI National Clinical Trials Network - Network Group Operations Centers (U10 Clinical Trial Required)

Key Dates

None

National Cancer Institute (NCI)

The National Cancer Institute (NCI) intends to issue a U10 NCI National Clinical Trials Network (NCTN) – Network Group Operations Centers notice of funding opportunity (NOFO). The NCTN Network Group Operations Centers will provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of cancer types and special populations with specific scientific strategy and goals. 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.
 

This Notice encourages investigators with expertise and experience to provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy to begin to consider applying for this NOFO. The Operations Centers' scientific goals may also include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional cancer treatment clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. The Operations Centers are also responsible for robust accrual to NCTN trials by the applicant's member institutions/sites, including trials led by the applicant and those led by other NCTN Network Group Operations Centers.

Funding Information

Only the current awardees or subrecipients, (including second-tier subrecipients), with a substantial role in the existing Network Group Operations Center infrastructure supported under RFA-CA-19-056 are eligible to apply. Substantial role may be defined as employing one or more of the existing multiple PD/PIs, receiving a substantial (25% or more) amount of the current award or employing a significant number of the staff required to support the existing infrastructure. An organization applying for an NCI National Clinical Trials Network (NCTN) Group Operations Center award cannot apply for a Network Statistics and Data Management Center under this NOFO for the same project period. Applications are not being solicited at this time.

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