Opportunity Information: Apply for RFA DK 18 010
The Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Not Allowed) funding opportunity (RFA-DK-18-010) is a National Institutes of Health cooperative agreement designed to establish and support a single Data Coordinating Center (DCC) for the Diabetic Foot Consortium (DFC), a clinical research effort focused on diabetic foot ulcers. The program is built around the reality that diabetic foot ulcer research is clinically complex, with outcomes influenced by multiple patient, wound, vascular, metabolic, infectious, and treatment factors. Because of that complexity, the FOA emphasizes that applicants must already have direct experience serving as a data coordinating center on clinical studies specifically involving diabetic foot ulcers, rather than only general clinical trial coordination experience. The DCC is expected to act as the operational and analytical backbone for the consortium, enabling participating clinical sites and investigators to run studies with consistent methods, high-quality data, and coordinated oversight.
The initial scientific focus of the consortium is on validating biomarkers that can predict key clinical outcomes in diabetic foot ulcers, including whether a wound is likely to heal, whether a patient is likely to respond to a given therapy, and the likelihood of infection or ulcer recurrence. In practical terms, this means early consortium studies will likely involve standardized sample and data collection across sites, rigorous definitions of endpoints such as healing and infection, and carefully designed statistical plans to test the predictive performance of candidate biomarkers. Beyond these first studies, the FOA signals that the consortium may expand into additional clinical research, potentially including future clinical trials and studies aimed at understanding the underlying pathophysiology of diabetic foot ulcers. Even though the specific U24 described here is labeled "Clinical Trial Not Allowed," the DCC still needs to be capable of supporting complex, multi-site clinical research infrastructure now while remaining adaptable as the consortium evolves toward broader research activities.
The DCC responsibilities described in the announcement are extensive and cover both operational coordination and technical data functions. On the coordination and administrative side, the DCC is expected to provide overall project management for the consortium, including organizing timelines, supporting consortium governance, coordinating communication among clinical sites and investigators, and ensuring that the studies are executed consistently across locations. This typically includes scheduling and supporting investigator meetings, maintaining documentation and standard operating procedures, tracking study milestones, and helping resolve cross-site implementation issues. On the quality control side, the DCC is expected to implement systems that ensure data completeness, accuracy, and protocol adherence. That often involves training and certification processes for site staff, guidance on standardized wound assessments, monitoring data entry patterns, issuing and resolving data queries, and developing metrics that show whether sites are collecting data uniformly and on time.
On the data and analytics side, the FOA makes clear that the DCC must provide robust data management and biostatistical support. This includes developing and maintaining the study database(s), creating and managing case report forms and data dictionaries, ensuring secure handling of clinical and laboratory data, and integrating data from multiple sources when needed. The DCC would also be responsible for the statistical design and analysis plans that match the consortium's scientific aims, including biomarker validation methods, modeling approaches to predict healing or recurrence, handling missing data, and generating interim and final analytical reports. Because biomarker validation often depends on careful attention to sample timing, outcome definitions, and confounding factors, the DCC is expected to bring enough biostatistical sophistication to support reproducible analyses that can stand up to external scrutiny and ultimately help shape clinical decision-making.
From an administrative standpoint, this is a discretionary funding opportunity using a cooperative agreement mechanism, meaning the NIH is expected to have substantial programmatic involvement in how the work is carried out compared to a typical grant. The program was issued by the US Department of Health and Human Services through the NIH, with the opportunity categorized under health and food and nutrition-related activity (CFDA 93.847). The announcement anticipated one award, with an award ceiling of $500,000. Eligibility was broad and included many common research and public entities, such as state and local governments, public and private institutions of higher education, tribal governments and organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other applicants as clarified in the full announcement. The FOA was originally posted in November 2018 with an original closing date of January 23, 2019, indicating it was a time-limited competitive solicitation for a single coordinating center to anchor the consortium's early phase.
Overall, the opportunity is essentially seeking a highly experienced, disease-area-specific coordinating center that can run the operational core of a multi-site diabetic foot ulcer research program. The most important themes are demonstrated prior experience coordinating diabetic foot ulcer clinical studies, the ability to deliver rigorous data systems and quality management, and strong biostatistical capacity to support biomarker validation and other complex analyses. The end goal is to give the Diabetic Foot Consortium the shared infrastructure it needs to produce reliable, clinically meaningful evidence about healing prediction, treatment response, and risks like infection and recurrence, while positioning the consortium for expansion into future research directions.Apply for RFA DK 18 010
- The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
- This funding opportunity was created on Nov 08, 2018.
- Applicants must submit their applications by Jan 23, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs): Data Coordinating Center for the Diabetic Foot Consortium (U24 Clinical Trial Not Allowed) - RFA-DK-18-010
1) What is this funding opportunity?
This opportunity (RFA-DK-18-010) is a National Institutes of Health (NIH) cooperative agreement to establish and support a single Data Coordinating Center (DCC) for the Diabetic Foot Consortium (DFC), a clinical research effort focused on diabetic foot ulcers.
2) What is the overall purpose of the Data Coordinating Center (DCC)?
The DCC is intended to serve as the operational and analytical backbone of the consortium. Its role is to help multiple clinical sites and investigators run studies using consistent methods, produce high-quality data, and operate under coordinated oversight.
3) Why does the FOA emphasize diabetic foot ulcer-specific DCC experience?
The FOA highlights that diabetic foot ulcer research is clinically complex, with outcomes influenced by multiple patient, wound, vascular, metabolic, infectious, and treatment factors. Because of that complexity, the announcement emphasizes that applicants must already have direct experience serving as a data coordinating center on clinical studies specifically involving diabetic foot ulcers, not just general clinical trial coordination experience.
4) Is this a clinical trial grant?
No. The opportunity is labeled "U24 Clinical Trial Not Allowed." The DCC is being funded to provide coordinating center infrastructure and support for consortium studies rather than to run a clinical trial under this specific U24.
5) If clinical trials are not allowed, why does the DCC need to support complex multi-site research?
Even though this U24 is "Clinical Trial Not Allowed," the DCC is still expected to support complex, multi-site clinical research infrastructure. The FOA also signals the consortium may expand in the future into additional clinical research, potentially including future clinical trials and studies of underlying pathophysiology, so the DCC should be capable now and adaptable later.
6) What is the initial scientific focus of the Diabetic Foot Consortium?
The initial focus is validating biomarkers that can predict key clinical outcomes in diabetic foot ulcers, such as whether a wound is likely to heal, whether a patient is likely to respond to a given therapy, and the likelihood of infection or ulcer recurrence.
7) What kinds of outcomes and endpoints are emphasized?
The FOA highlights endpoints and outcomes such as wound healing, treatment response, infection, and ulcer recurrence. Early studies are expected to use rigorous, standardized definitions for endpoints like healing and infection across sites.
8) What does biomarker validation imply for consortium study operations?
Based on the FOA description, biomarker validation will likely require standardized sample and data collection across sites, careful attention to sample timing, clear outcome definitions, and statistical approaches that can evaluate predictive performance while addressing confounding factors and missing data.
9) What are the DCC's main administrative and coordination responsibilities?
The DCC is expected to provide overall project management for the consortium. This includes organizing timelines, supporting consortium governance, coordinating communication among clinical sites and investigators, scheduling and supporting investigator meetings, maintaining documentation and standard operating procedures (SOPs), tracking study milestones, and helping resolve cross-site implementation issues.
10) What does the FOA expect for data quality control and protocol adherence?
The DCC is expected to implement systems to ensure data completeness, accuracy, and adherence to protocol. Examples described include training and certification processes for site staff, guidance on standardized wound assessments, monitoring data entry patterns, issuing and resolving data queries, and developing site performance metrics to show whether data are collected uniformly and on time.
11) What are the DCC's data management responsibilities?
The DCC is expected to develop and maintain the study database(s), create and manage case report forms (CRFs) and data dictionaries, ensure secure handling of clinical and laboratory data, and integrate data from multiple sources when needed.
12) What biostatistical responsibilities are expected of the DCC?
The DCC is expected to provide statistical design and analysis plans aligned with consortium aims. This includes biomarker validation methods, modeling approaches to predict healing or recurrence, approaches for handling missing data, and production of interim and final analytical reports. The FOA emphasizes the need for biostatistical sophistication to support reproducible analyses that can withstand external scrutiny.
13) What makes diabetic foot ulcer research especially challenging from a coordination and data perspective?
The FOA points to clinical complexity and multiple drivers of outcomes, including patient factors, wound characteristics, vascular status, metabolic status, infection, and treatment factors. That combination increases the need for consistent measurement, standardized definitions, cross-site training, and robust analytics.
14) How many awards were anticipated under this FOA?
The announcement anticipated one award to support a single Data Coordinating Center for the consortium.
15) What was the anticipated award ceiling?
The announcement anticipated an award ceiling of $500,000.
16) What funding mechanism is used?
This is a discretionary funding opportunity using a cooperative agreement mechanism (U24). In a cooperative agreement, NIH is expected to have substantial programmatic involvement compared to a typical grant.
17) Which federal agency issued this opportunity?
The opportunity was issued by the US Department of Health and Human Services through the National Institutes of Health (NIH).
18) What is the CFDA number and program category mentioned?
The FOA is categorized under health and food and nutrition-related activity and references CFDA 93.847.
19) Who was eligible to apply?
Eligibility was broad and included state and local governments, public and private institutions of higher education, tribal governments and organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other applicants as clarified in the full announcement.
20) When was the FOA posted and when did it close?
The FOA was originally posted in November 2018 and had an original closing date of January 23, 2019, indicating it was a time-limited competitive solicitation.
21) What types of studies were expected early in the consortium?
Early studies were expected to focus on biomarker validation and therefore likely involve standardized sample and data collection across sites, rigorous endpoint definitions (for example, healing and infection), and statistical plans designed to test predictive performance.
22) Could the consortium's scope expand beyond biomarker validation?
Yes. The FOA signals the consortium may expand into additional clinical research, potentially including future clinical trials and studies aimed at understanding the underlying pathophysiology of diabetic foot ulcers.
23) What is meant by the DCC being the "operational and analytical backbone"?
In practice, this means the DCC is expected to provide centralized project management, standardized procedures, communication and governance support, data systems, quality management, and statistical leadership so that research across multiple sites is consistent, reliable, and interpretable.
24) What are the main themes the FOA appears to prioritize in applicants?
The key themes described are: demonstrated prior experience coordinating diabetic foot ulcer clinical studies, the ability to deliver rigorous data systems and quality management, and strong biostatistical capacity to support biomarker validation and other complex analyses.
25) What is the intended impact of funding a single DCC for the Diabetic Foot Consortium?
The described goal is to give the consortium shared infrastructure needed to generate reliable, clinically meaningful evidence about healing prediction, treatment response, and risks such as infection and recurrence, while positioning the consortium to expand into future research directions.
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