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Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Statistical Center (DMASC) (UG1 Clinical Trial Required)

National Institutes of Health

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) proposes and will support the Cancer Prevention Clinical Trials Network (CP-CTNet), for which the goals are as follows:

Design and conduct of early phase clinical trials to assess the safety, tolerability, and cancer preventive potential of agents and interventions of varying classes, many of which target molecules or processes known to be important during carcinogenesis. These trials include phase 0 (micro-dosing), phase I (dose-finding), and phase II (preliminary efficacy) clinical trials.
Characterization of the effects of these agents and interventions on their molecular targets, as well as on other biological events associated with cancer development (such as cell proliferation, apoptosis, growth factor expression, oncogene expression, immune response) and correlation of these effects with clinical endpoints.
Development of further scientific insights into the mechanisms of cancer prevention by the agents examined, including the development of novel potential markers as determinants of response.

CP-CTNet consists of two types of components:

CP-CTNet Sites (covered by companion NOFO, RFA-CA-24-024 ); and
One CP-CTNet Data Management, Auditing, and Statistical Center (DMASC, covered by this NOFO).

The CP-CTNet Sites will provide scientific leadership in development and conduct of early phase cancer prevention clinical trials as well as in the management and analysis of the data. The DMASC will support the CP-CTNet Sites and coordinate trans-Network activities with the following specific responsibilities:

(i) centralized data management and data reporting,

(ii) clinical trials auditing

(iii) statistical support, and

(iv) administrative support across CP-CTNet.

Deadlines:

Letter of Intent: 30 days prior to the application due date
Application: Oct. 31, 2024

RFA-CA-24-025 Expiration Date November 01, 2024

Specialties

Medical

Medical - Clinical Science

Eligibility Requirements

The individual designated as PD/PI for the CP-CTNet DMASC must have their primary affiliation at the application-submitting institution. For proposals with Multiple PDs/PIs, the second individual designated as MPI may have a primary affiliation at a different US institution.

These individuals are expected to be nationally and internationally recognized leaders in management and stewardship of network-based/multicenter clinical trials. Their expertise should broadly encompass the four functional areas of DMASC activities, viz., data management and reporting, clinical trials auditing, statistical support, and administrative and logistical coordination. It is expected that the PDs/PIs lead a multi-disciplinary team comprised of domain-specific experts with substantial experience in leading each of the four functional areas of the CP-CTNet DMASC.

The PDs/PIs of applications submitted in response to this NOFO must not be named as Senior/Key Personnel or Other Significant Contributors on any teams submitting applications to the companion NOFO, RFA-CA-24-024 .