Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (U24 Clinical Trial Required)

Funding Agency:
National Institutes of Health

Through this funding opportunity announcement (FOA), 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:

Five CP-CTNet Sites (covered by companion FOA, RFA-CA-18-029); and

One CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC, covered by this FOA).

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 DMACC 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, and

(iii) administrative and logistical coordination across CP-CTNet.

Each applicant organization may submit only one application.

Deadlines:

  • Duke Internal Deadline: Applications for internal review are due to Erin Carr erin.carr@duke.edu no later than Thursday, October 11th  (please send your application in one PDF). 
  • Letter of Intent Due Date(s): October 15, 2018
  • Application Due Date(s): November 15, 2018

RFA-CA-18-030 Expiration Date November 16, 2018

Agency Website

Eligibility Requirements

Any individual(s) designated as PD(s)/PI(s) for the CP-CTNet DMACC must have their primary affiliation at the application-submitting 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 three functional areas of DMACC activities, viz., data management and reporting, clinical trials auditing, 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 three functional areas of the CP-CTNet DMACC.

The PDs/PIs of applications submitted in response to this FOA must not be named as Senior/Key Personnel or Other Significant Contributors on any teams submitting applications to the companion FOA, RFA-CA-18-029.

      Amount Description

      The requested budget must not exceed $1.25M in direct costs for year 1 and $1.90M in direct costs for subsequent years.

       All applicants should request a 5-year project period. 

          Funding Type

          Grant

          Eligibility

          Faculty
          Institutional

          Category

          Medical
          Medical - Clinical Science
          Medical - Translational

          Internal Nomination

          The Duke Cancer Institute is invited to submit one nominee, thus will be conducting an internal review of applications. The following items are required and will be reviewed by the DCI’s Scientific Review Committee.

          1. Applicant’s NIH Biosketch

          2. Two (2) page summary including the following information:

          * Title of the proposed research project

          * Brief description of the research proposal

          * Brief statement of applicant’s eligibility

          Applications for internal review are due to Erin Carr erin.carr@duke.edu no later than Thursday, October 11th  (please send your application in one PDF).  Selected nominees will be notified by Thursday, October 25th.

          Internal Deadline

          October 11, 2018

          External Deadline

          November 15, 2018