Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (U24 Clinical Trials Required) | RFA CA 18 030

Frequently Asked Questions (FAQs)

What is the funding opportunity described here?

This opportunity is the Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) funding opportunity, RFA-CA-18-030. It is a National Cancer Institute (NCI), NIH cooperative agreement that supports the infrastructure needed to run a national network focused on early phase cancer prevention clinical trials.

What is CP-CTNet designed to do?

CP-CTNet is designed to move promising cancer prevention agents and interventions through early phase clinical testing, specifically phase 0 (microdosing), phase I (dose finding), and phase II (preliminary efficacy) studies. The program emphasizes understanding how these approaches affect carcinogenesis-related molecular pathways and biological processes, while linking mechanistic findings to clinical endpoints.

What types of clinical trial phases are emphasized in CP-CTNet?

The network emphasizes early phase trials, including phase 0 (microdosing), phase I (dose finding), and phase II (preliminary efficacy).

What scientific outcomes does CP-CTNet emphasize beyond safety and tolerability?

In addition to testing safety and tolerability, CP-CTNet emphasizes generating mechanistic evidence. Examples include changes in target engagement, cell proliferation, apoptosis, growth factor signaling, oncogene expression, and immune response, and then connecting those findings to clinical endpoints.

How does CP-CTNet approach biomarkers or markers of response?

A key scientific aim is to deepen understanding of prevention mechanisms and help develop and refine biomarkers or other markers that can predict or measure response.

What are the main components of CP-CTNet?

CP-CTNet is structured around two complementary components: five CP-CTNet clinical trial Sites (solicited under the companion FOA RFA-CA-18-029) and one centralized Data Management, Auditing, and Coordinating Center (DMACC) (solicited under this FOA, RFA-CA-18-030).

What is the difference between the CP-CTNet Sites and the DMACC?

The Sites are described as the scientific engines of the network and are responsible for proposing, developing, and conducting early phase prevention trials and for managing and analyzing trial data. The DMACC is described as the backbone that coordinates the network, providing centralized data functions, auditing, and administrative/logistical coordination so the network operates as a unified system rather than separate projects.

What is the award mechanism for the DMACC opportunity?

The FOA calls for a U24 award mechanism, and clinical trials are required.

Does this opportunity require clinical trials activities?

Yes. The FOA indicates "clinical trials required," reflecting that the DMACC is expected to directly support the execution and oversight of clinical trials activities across the network.

What does it mean that this is a cooperative agreement?

This is a cooperative agreement funding instrument, and the description indicates that NIH/NCI program staff typically have substantial involvement in steering and coordination under this structure.

What are the three central responsibilities of the DMACC?

The DMACC has three central responsibilities: (1) centralized data management and data reporting for CP-CTNet studies, (2) clinical trials auditing, and (3) administrative and logistical coordination across CP-CTNet.

What is meant by centralized data management and reporting in this FOA?

Centralized data management and reporting generally includes building and maintaining systems and processes for consistent data collection, cleaning, quality control, database management, and standardized reporting across multiple trials and institutions so that results are reliable and comparable.

What is the auditing function expected of the DMACC?

The DMACC is expected to conduct clinical trials auditing to help ensure participating sites follow protocols and regulatory requirements, that source documentation and case report data align, and that participant safety and data integrity are protected through routine and for-cause audits.

What does administrative and logistical coordination include for the DMACC?

Administrative and logistical coordination commonly includes organizing network communications, meetings, timelines, cross-site operational alignment, and other trans-network activities needed to keep trials moving efficiently and consistently across all participating sites.

What is the companion FOA for the CP-CTNet Sites?

The companion FOA for the CP-CTNet clinical trial Sites is RFA-CA-18-029, while this DMACC opportunity is RFA-CA-18-030.

Who is eligible to apply for this DMACC funding opportunity?

Eligibility is broad across U.S.-based organizations and includes many government entities (state, county, city/township, special district), public and private institutions of higher education, independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and other eligible applicants.

Are minority-serving institutions and certain community organizations included in the eligible applicant categories?

Yes. The FOA explicitly highlights additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISIs, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are non-U.S. (non-domestic) organizations eligible to apply?

No. Non-domestic (non-U.S.) entities are not eligible to apply.

Can a U.S. applicant include any foreign involvement in the project?

Yes, foreign components (as defined by NIH policy) are allowed, meaning a U.S. applicant can include certain foreign elements in the project when justified and compliant with NIH rules. However, non-domestic components of U.S. organizations are not eligible to apply.

How is this opportunity categorized administratively?

It is listed as a discretionary funding opportunity using a cooperative agreement funding instrument, within education and health activity categories.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.393 and 93.399.

When was this opportunity created and when did it close?

The opportunity was created on September 14, 2018, and had an original closing date of November 15, 2018.

Is the award ceiling provided in the information above?

No. The award ceiling is not specified in the provided source text.

Is the expected number of awards provided in the information above?

No. The expected number of awards is not specified in the provided source text.

In practical terms, what kind of organization is this FOA seeking for the DMACC?

The FOA is seeking a capable, experienced coordinating center that can standardize and safeguard data and operations across multiple early phase cancer prevention trials, while also providing auditing and network-level coordination needed to ensure high-quality, compliant, and interpretable results.