The Chronic Pancreatitis Clinical Research Consortium (CPCRC)- Clinical Centers (CPCRC-CCs) (U01 Clinical Trial Optional) | RFA DK 25 019

FAQs: CPCRC Clinical Centers (RFA-DK-25-019)

1) What is the CPCRC Clinical Centers funding opportunity?

RFA-DK-25-019 is a National Institutes of Health (NIH) cooperative agreement funding opportunity (U01; clinical trial optional) to support Clinical Centers within the Chronic Pancreatitis Clinical Research Consortium (CPCRC). The goal is to continue a multi-site clinical research network focused on chronic pancreatitis and closely linked conditions, including pancreatogenic diabetes (type 3c diabetes, or T3cDM) and pancreatic cancer risk.

2) Is this opportunity intended to start a brand-new research program?

No. The intent is to maintain and build on existing momentum and to successfully conduct and complete ongoing longitudinal studies that have been underway since the consortium was established in 2015, rather than launching a new program from scratch.

3) What larger consortium does this NOFO fit into?

This Clinical Centers opportunity is part of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC). CPDPC is structured around multiple funded Clinical Centers (CCs) that work closely with a separate Coordination and Data Management Center (CDMC).

4) What conditions and scientific topics are emphasized?

The NOFO emphasizes deep clinical characterization of people with chronic pancreatitis, including individuals who experience acute recurrent pancreatitis (ARP). It also addresses pancreatogenic diabetes (type 3c diabetes), chronic pain, pancreatic insufficiency, and the relationship between diabetes and pancreatic cancer risk.

5) Which patient populations are included in the consortium’s scope?

The scope spans both pediatric and adult populations and includes people with chronic pancreatitis and individuals with acute recurrent pancreatitis (ARP), as described in the NOFO summary.

6) What kinds of studies are Clinical Centers expected to support?

Clinical Centers are expected to contribute to multi-site longitudinal studies focused on disease mechanisms and progression, with attention to key clinical outcomes and complications such as pain, pancreatic insufficiency, development of type 3c diabetes, and links to pancreatic cancer risk.

7) Does the consortium also study pancreatic cancer risk in people with diabetes?

Yes. In parallel with pancreatitis-focused work, the consortium investigates pancreatic cancer development in people with newly diagnosed diabetes, reflecting the concern that new-onset diabetes may be an early sign or risk state associated with pancreatic cancer in some individuals.

8) What does it mean that this is a cooperative agreement (U01)?

Because this is a cooperative agreement, awardees should expect substantial coordination with NIH program staff and structured collaboration across sites, rather than operating as isolated, fully independent projects.

9) What role do NIH program staff and cross-site collaboration play?

The NOFO indicates that the work will involve structured collaboration across the consortium and substantial coordination with NIH program staff, consistent with a cooperative agreement model.

10) What is the expected team structure at a Clinical Center?

Clinical Centers are expected to bring a multidisciplinary team aligned with the consortium’s objectives. Disciplines typically include gastroenterology/hepatology, pancreatic surgery, endocrinology/diabetes care, oncology or cancer risk expertise, pain management, radiology, pathology, genetics, epidemiology, biostatistics, and clinical research operations.

11) What are Clinical Centers expected to contribute to the consortium?

Clinical Centers are expected to contribute patients, data, biospecimens, and clinical expertise to shared consortium studies aiming to improve understanding of risk, disease progression, and earlier prediction or better management of outcomes.

12) Are Clinical Centers expected to share data and results within the consortium?

Yes. The NOFO highlights expectations that Clinical Centers will share results freely within the consortium and participate in trans-consortium collaborative projects leveraging combined expertise, patient populations, and technical capabilities.

13) How important are harmonized protocols and standardization across sites?

Central to this networked model are harmonized protocols, common data elements, standardized specimen handling, and coordinated analyses. The NOFO summary emphasizes these features as key to productivity and impact.

14) What is the Coordination and Data Management Center (CDMC), and how does it relate to Clinical Centers?

The CPDPC infrastructure includes a dedicated Coordination and Data Management Center (CDMC) that is solicited under a separate companion announcement (RFA-DK-25-018). Clinical Centers are expected to integrate smoothly with this centralized coordinating structure for cross-site operations.

15) What functions are typically handled by the CDMC?

The CDMC typically handles cross-site data coordination, database and informatics support, quality control, statistical support, and operational coordination for multi-center studies.

16) What operational capabilities should Clinical Center applicants be prepared to describe?

Based on the description provided, Clinical Center applicants should be prepared to describe plans and capabilities for enrollment and retention, adherence to consortium protocols, timely data entry and query resolution, biospecimen collection and shipping workflows, and readiness to participate in consortium governance (such as steering committee participation and working groups).

17) Is a clinical trial required under this opportunity?

The funding mechanism is described as U01 with “clinical trial optional,” meaning the opportunity allows for clinical trial activities but does not state that a clinical trial is required based on the information provided.

18) Who is eligible to apply?

Eligibility is broad and includes U.S. state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, tribal governments, and housing authorities. The NOFO also explicitly lists a variety of mission-focused institution types as eligible, including HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, and certain federal agencies.

19) Are non-U.S. (foreign) organizations eligible to apply as the applicant institution?

No. Non-U.S. (foreign) organizations are not eligible to apply as applicant institutions, based on the information provided.

20) Can a U.S. organization include a non-U.S. component in its application?

Non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components (as NIH defines them) may be permitted in limited, well-justified circumstances where parts of the work occur abroad under a U.S. prime recipient, when allowed by NIH policy and project needs.

21) What is the companion announcement mentioned, and why does it matter?

The companion announcement is RFA-DK-25-018, which solicits the Coordination and Data Management Center (CDMC). It matters because the Clinical Centers funded under RFA-DK-25-019 are expected to coordinate closely with the CDMC for centralized data and operational management.

22) What is the posted award ceiling for this opportunity?

The posted award ceiling is $400,000, as stated in the information provided.

23) What is the application due date listed for this funding opportunity?

The original application due date is October 18, 2024.

24) What type of program is this listed as (administratively)?

This opportunity is listed as a discretionary program and uses a cooperative agreement funding instrument. It is categorized under health-related activity (Food and Nutrition, Health) with CFDA number 93.847.

25) What is the practical “fit” for an applicant Clinical Center?

The practical fit described is an institution that can reliably execute multi-site longitudinal research; recruit and follow well-characterized patient cohorts; contribute high-quality data, biospecimens, and clinical expertise; and operate effectively in a highly collaborative consortium environment with centralized coordination and strong expectations for sharing data, results, and resources.