NCI Cancer Screening Research Network: Statistics and Data Management Center (UG1 Clinical Trial Required)

Background
The National Cancer Institute (NCI) is providing infrastructure to develop and conduct national cancer screening clinical trials and studies through the Cancer Screening Research Network (CSRN). The primary goal of the CSRN is to engage large and diverse populations in rigorous studies focused on cancer screening to improve early cancer detection and evaluate emerging cancer screening modalities with the ultimate goal of reducing cancer incidence, and cancer-related morbidity and mortality.

Grant Details
The CSRN will support the Statistics and Data Management Center (SDMC) which will provide statistical expertise, centralized data management, quality control, and reporting in support of CSRN clinical trials and other cancer screening studies. The SDMC will be responsible for developing statistical design and analysis plans for clinical trials, trial monitoring, data collection, monitoring processes, procedures for clinical trials, including participant randomization, early stopping rules for safety and futility, interim analyses, participant demographic analyses, establishment and management of the Data Safety and Monitoring Board (DSMB), timely publication of study results, results reporting per NIH/NCI and federal regulations.

The SDMC will also ensure the integrity of clinical trials including randomization, interim analyses, early stopping rules for safety and futility, high-quality data management support (collection and monitoring), timely trial completion, publication of trial data with the research community.

Eligibility Requirements
Only one application per institution is allowed. Applicants must have prior experience using Medidata Rave for study set-up and data management. Recipients will be required to use the NCI clinical research infrastructure in the conduct of CSRN trials including the Regulatory Support System (RSS), the Oncology Patient Enrollment Network (OPEN), Registration and Credentialing Repository (RCR), Medidata Rave, Medidata Targeted Source Data Verification (TSDV), the NCI Central Institutional Review Board (CIRB), the CTEP AERS System, Cancer Trial Support Unit (CTSU), and the NCI National Clinical Trials Reporting Program (CTRP).

Period of Performance
The maximum project period is 4 years. The earliest start date is February 28, 2023.

Grant Value
NCI intends to commit $1M in FY 2024 to fund 1 award. It is expected that $2M will be allocated per year in subsequent years for the SDMC.