Internal Deadline: Contact ORIF.
LOI: January 28, 2023
External Deadline: February 28, 2023, 5pm PT
Award Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Award Amount: $1M
Who May Serve as PI: Standard NIH requirements.
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.
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 screening randomized control trial.
- 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 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 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 goal, the SDMC will be expected to have the expertise and capacity to contribute the following:
- Provide the statistical leadership and expertise required to assure the effective scientific design and conduct of clinical trials and other cancer screening studies.
- Ensure the integrity of clinical trials including randomization and establishment of interim analyses and early stopping rules for safety and futility.
- Provide high-quality data management support (collection and monitoring) and procedures to ensure appropriate trial and study conduct, reporting of adverse events, and timely trial completion and publication.
- Collect, store, and provide quality control for all participant data for cancer screening trials and studies. This includes, but is not limited to the data management, the design of all trial forms and questionnaires, and the design and operation of systems for secure and timely receipt of trial data from the ACCESS Hubs.
- Support processes to promote the collection of long-term follow-up data for both screen positive and screen negative participants.
- Produce interim trial reports for the Data Safety Monitoring Board.
- Develop and implement a plan for sharing trial data with the research community.
- Collaborate with the NCI program staff including statisticians to develop and execute plans for analysis and quality control of trial data, and assist with trial publications. This will involve data sharing with the NCI statisticians and program staff at pre-specified time points for the Vanguard study.
- Coordinate auditing and trial conduct in a collaborative and integrated manner with the CCC.
- Ensure compliance with all federal and international standards for clinical research.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.