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RFA-CA-23-022: NCI Cancer Screening Research Network: Coordinating and Communication Center (UG1 Clinical Trial Required)

Slots: 1

Deadlines

Internal Deadline: Contact ORIF.

LOI: January 28, 2023

External Deadline:  February 28, 2023, 5pm PT

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $1.5M 

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-022.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://rii.usc.edu/oor-portal/.

Materials to submit include:

  • (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

Key Terms for this FOA

  • The terms “Clinical Research” and “Clinical Trials” in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch.)
  • ACCESS Hub: An organization or group of organizations which consists of institutions that may be individual institutions with affiliate members, healthcare systems, successful practice-based research networks, other relevant institutions, or any combination thereof, that includes a single scientific leadership team that is responsible for study procedures and participant recruitment into CSRN trials and studies.
  • Affiliate Organization (AO): An Affiliate Organization refers to a hospital, clinic, primary care practice, or other institution where participants are enrolled on a regular and ongoing basis to CSRN-approved clinical trials.
  • NCI Central Institutional Review Board (CIRB): A centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Overall Goals of CSRN and Scope of this FOA

Overall Goals of CSRN: The overall goal of the CSRN is to evaluate technologies and strategies for the purpose of cancer screening in asymptomatic individuals.

To successfully achieve this goal, the CSRN must:

  • Establish the organizational and administrative infrastructure of all necessary components needed to implement cancer screening clinical studies and trials, especially a large, randomized control trial for cancer screening.
  • Develop cancer screening trials to evaluate emerging cancer detection modalities for clinical utility.
  • Assess the clinical utility of cancer screening programs or biomarkers of detection including downstream interventions and health outcomes.
  • Apply precision medicine approaches to screening using novel risk assessment tools to individualize screening protocols.
  • Evaluate the effectiveness, feasibility, and scalability of screening strategies in real-world settings.
  • Identify and address technical, process, and/or cultural challenges to adapt the implementation of screening strategies for diverse practice settings.
  • Conduct surveillance of cancer screening in diverse populations to track progress and characterize reach and health outcomes across populations.
  • Develop cancer screening studies to evaluate clinical workflow and coordination of care.

This Network will conduct clinical trials and other types of research studies to address the clinical utility, effectiveness, implementation, and other questions related to a wide variety of established and emerging screening methods, technologies, and strategies.

Scope of this FOA: The scope of research conducted by the CSRN will include the evaluation of technologies for early detection of cancer, but not for the purpose of detection of recurrence of a previously treated cancer.

To support the CSRN goals, the CCC will be expected to have the expertise and capacity to contribute the following:

  • Provide scientific leadership in the overall development, conduct, and coordination of cancer screening clinical trials and observational studies within the CSRN.
  • Work collaboratively with the NCI program staff in the creation and management of study operations including the development and implementation of communication activities for trials and studies.
  • Develop and implement trial-specific participant recruitment and retention strategies. This includes devising specific recruitment approaches for underrepresented populations including racial, ethnic, and religious minorities, rural populations, and others.
  • Develop participant-facing materials in plain language and sensitive to specific populations as necessary for trial recruitment and retention.
  • Develop and update the trial information website.
  • Produce and distribute messages and graphics appropriate for use by ACCESS Hubs on a variety of social media platforms with translations to languages other than English.
  • Coordinate protocol development and management for the CSRN including the Vanguard pilot study. Trial design activities will be undertaken in collaboration with the NCI program staff, SDMC, and ACCESS Hubs. NCI will review and have final approval for the trial protocol and all subsequent amendments.
  • Ensure compliance with NIH, FDA, OHRP, and other federal requirements.
  • Conduct audits and site visits of ACCESS Hubs and Affiliate Organizations.
  • Coordinate specimen collection for biobanking.
  • Work collaboratively and in an integrated manner with the SDMC and ACCESS Hubs.
  • Facilitate the development and management of a Participant Advisory Committee.
  • Develop affiliation agreements with each ACCESS Hub, its affiliate organizations, and the SDMC.
  • Provide education, training, and support to ACCESS Hubs and monitor and evaluate the performance of the individual ACCESS institutions. Together with the SDMC, the CCC will monitor and evaluate the diversity of the participant population and tailor strategies for recruitment and retention to improve the diversity of the participant pool.
  • Provide support for ACCESS Hubs to integrate new investigators and institutions into the NCI rostering system.
  • Plan and facilitate meetings for the Network Steering Committee and any subcommittees or working groups under the Steering Committee. The Steering Committee will include members from all components of the Network and the NCI program staff.
  • Facilitate the development of the Data Safety Monitoring Board for trials and other Network activities for CSRN studies.
  • Interact with companies providing materials to CSRN trials, and, in consultation and collaboration with NCI program staff, participate in the technology assessment and selection process. For example, the CCC may participate in the MCD assay evaluation and selection process for participation in a CSRN study.
  • Collaborate with the SDMC and ACCESS Hubs to develop and implement the Vanguard pilot study. This protocol will be developed with the close involvement of NCI staff and its results will inform the design of future large-scale clinical trials.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.