Opportunity Information: Apply for RFA FD 17 014
The Global Pediatric Clinical Trials Network grant opportunity (RFA-FD-17-014) is an FDA Cooperative Agreement designed to build the scientific and operational infrastructure needed to run better, faster, and more reliable pediatric clinical trials worldwide. The program is rooted in the long-running challenge that, even after major policy efforts like the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), many medications are still used off-label in children. The notice highlights how common this remains, citing off-label use rates as high as about 60 percent for children overall and up to about 90 percent in neonatal intensive care units. While BPCA and PREA have contributed to hundreds of pediatric labeling updates, the FDA notes that a meaningful share of pediatric trials have not produced evidence strong enough to support an approved pediatric indication. Those failures may reflect fundamental gaps in pediatric trial planning, such as choosing the wrong drug or dose, enrolling the wrong population, using trial designs that do not fit pediatric realities, or relying on endpoints that do not capture meaningful benefit or risk in children. Recruitment difficulties, especially for rare diseases, are also called out as a frequent reason trials stall or fail.
A central theme of the opportunity is that pediatric trials succeed when the field goes beyond simply repeating adult approaches and instead builds pediatric-specific evidence strategies. The FDA emphasizes several scientific needs that should feed directly into trial design and execution: better use of disease biology and pathophysiology to justify when adult efficacy data can be responsibly extrapolated to children; deeper understanding of how drug metabolism and relevant biological pathways change with age (ontogeny) so dosing can be optimized using modeling and simulation; and wider adoption of innovative designs such as master protocols and approaches proven in rare disease research. The opportunity also stresses the importance of integrating and standardizing multiple data sources, including prior clinical trials, patient registries, natural history studies, and electronic health records, so that pediatric development programs can be more efficient and better informed. In addition, it underscores the need for biomarkers across the full spectrum (susceptibility, diagnostic, monitoring, prognostic, predictive, safety, and response) and for endpoints that reflect meaningful short- and long-term outcomes in pediatric populations.
The grant is framed as a response to broad stakeholder consensus that no single organization can fix pediatric trial challenges alone. It points to a 2014 stakeholder forum convened by the American Academy of Pediatrics, supported by an unrestricted PhRMA grant, where clinicians, researchers, regulators, patient advocates, parents, industry, and disease-focused networks discussed the value of establishing a coordinated Global Pediatric Clinical Trials Network. It also builds on subsequent work by the Critical Path Institute, which launched the Pediatric Trials Consortium to advance a sustainable system capable of generating regulatory-quality data for pediatric labeling across drugs, biologics, and devices. The FDA expects applicants to align their proposed network with findings and recommendations from the Pediatric Trials Consortium Advisory Report, using it as the blueprint for how the network should operate and deliver value.
Practically, the program aims to create a standing, sustainable, global capability to plan, start up, conduct, and close out pediatric studies with high operational efficiency and consistent quality. The envisioned network is meant to be a go-to resource for pediatric product development, offering best practices, improved protocol design, training and education, and hands-on administrative tools that reduce burdens for investigators and sponsors. The FDA specifically describes a network that can provide expert, independent advice to investigators, streamline systems and processes, and raise trial quality while shortening timelines. A key deliverable is the coordination and management of a global set of pre-qualified, trial-ready pediatric sites, including the staff and infrastructure needed to reliably execute studies and improve recruitment, particularly for rare diseases where finding eligible patients is a persistent barrier.
The FDA lays out concrete capabilities it expects from the awardee. Applicants should show that they have developed, or have credible plans to develop, feasibility assessment reports to help determine whether proposed trials can realistically be executed. They should also demonstrate plans for educational programming and standardized training, and propose streamlined processes and efficient systems that directly improve trial quality, efficiency, and timeliness. The solicitation explicitly mentions the need for a site selection tool, core network infrastructure, and dedicated pediatric research staff. It also highlights governance and coordination elements such as independent advisory functions with robust stakeholder engagement, mechanisms for sharing information across the network, a centralized approach to institutional review board review to reduce duplicative administrative work, and a core set of performance metrics to measure value creation for stakeholders. Throughout, the FDA expects the network to operate with strong knowledge of regulatory standards and modern, innovative clinical research methods, while ensuring that advice and priorities reflect inclusive input from academia, industry, parent and patient groups, and government agencies.
Administratively, this was a discretionary funding opportunity issued by the Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, using a Cooperative Agreement mechanism, meaning the FDA anticipates substantial involvement and collaboration during the project rather than a purely hands-off grant. The opportunity listed an award ceiling of $2,000,000 with an expectation of one award. Eligibility was broad, spanning federal-recognized tribal governments and organizations, state and local governments, public and private universities, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), and individuals, subject to any additional eligibility clarifications in the full announcement. The original posting date was June 26, 2017, with an original closing date of August 22, 2017.Apply for RFA FD 17 014
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Global Pediatric Clinical Trials Network" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jun 26, 2017.
- Applicants must submit their applications by Aug 22, 2017. (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 $2,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County 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, Individuals, For profit organizations other than small businesses, Small businesses, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Global Pediatric Clinical Trials Network (RFA-FD-17-014) - Frequently Asked Questions
What is the Global Pediatric Clinical Trials Network grant opportunity (RFA-FD-17-014)?
RFA-FD-17-014 is an FDA Cooperative Agreement funding opportunity intended to build the scientific and operational infrastructure needed to run better, faster, and more reliable pediatric clinical trials worldwide. The focus is on creating a standing, sustainable network capability for pediatric product development.
Which federal agency is sponsoring this opportunity?
The opportunity is sponsored by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Office of the Commissioner.
What type of funding mechanism is used (grant vs. cooperative agreement)?
This opportunity uses a Cooperative Agreement mechanism. That means the FDA expects substantial involvement and collaboration during the project period, rather than operating as a hands-off funder.
What problem is this program trying to solve?
The program responds to long-standing challenges in pediatric clinical research, including the ongoing high rate of off-label medication use in children and the fact that many pediatric trials have not produced evidence strong enough to support an approved pediatric indication. It aims to address gaps in trial planning and execution that can lead to delays, stalled studies, or unusable results.
Why does the FDA highlight off-label use in children?
The notice emphasizes that off-label use remains common even after major policy efforts like BPCA and PREA. It cites off-label use rates as high as about 60 percent for children overall and up to about 90 percent in neonatal intensive care units, underscoring the need for stronger pediatric evidence and better-labeled therapies.
How do BPCA and PREA relate to this opportunity?
BPCA (Best Pharmaceuticals for Children Act) and PREA (Pediatric Research Equity Act) have contributed to hundreds of pediatric labeling updates, but the FDA notes that a meaningful share of pediatric trials still fail to generate evidence strong enough to support an approved pediatric indication. This opportunity is positioned as an infrastructure-level response to improve the quality and success rate of pediatric trials.
What are some reasons pediatric trials may fail, according to the notice?
The opportunity describes failures that can stem from fundamental planning gaps, such as selecting the wrong drug or dose, enrolling the wrong population, using trial designs that do not fit pediatric realities, or choosing endpoints that do not capture meaningful benefit or risk in children. Recruitment challenges, especially in rare diseases, are also highlighted as a frequent reason trials stall or fail.
What is the core goal of the funded network?
The core goal is to create a standing, sustainable, global capability to plan, start up, conduct, and close out pediatric studies with high operational efficiency and consistent quality, making the network a go-to resource for pediatric product development.
What does the FDA mean by building "scientific and operational infrastructure"?
Based on the notice, infrastructure includes both the scientific capabilities that improve trial design (for example, pediatric-specific evidence strategies and endpoint/biomarker development) and the operational capabilities that improve execution (for example, trial-ready sites, standardized training, streamlined systems, and tools for feasibility and site selection).
Does the network focus on copying adult trial approaches or pediatric-specific approaches?
The opportunity stresses that pediatric trials succeed when the field goes beyond simply repeating adult approaches and instead builds pediatric-specific evidence strategies tailored to children.
What scientific needs does the FDA emphasize for better pediatric trial design?
The notice calls for: (1) better use of disease biology and pathophysiology to justify when adult efficacy data can be responsibly extrapolated to children; (2) deeper understanding of age-related changes in drug metabolism and biological pathways (ontogeny) to optimize dosing using modeling and simulation; and (3) wider adoption of innovative trial designs, including master protocols and approaches proven in rare disease research.
What does the opportunity say about extrapolating adult efficacy data to children?
It emphasizes using disease biology and pathophysiology to justify when adult efficacy data can be responsibly extrapolated to pediatric populations, and implies this should feed directly into pediatric trial design and execution decisions.
How does dosing optimization fit into the program?
The FDA highlights the need to understand how drug metabolism and relevant biological pathways change with age (ontogeny) so that pediatric dosing can be optimized using modeling and simulation.
What kinds of innovative trial designs are encouraged?
The opportunity mentions innovative designs such as master protocols and other approaches that have been proven in rare disease research.
What data sources does the FDA want integrated and standardized?
The notice stresses integrating and standardizing multiple data sources, including prior clinical trials, patient registries, natural history studies, and electronic health records, to make pediatric development programs more efficient and better informed.
Why are biomarkers and endpoints a key theme in this opportunity?
The FDA underscores the need for biomarkers across the full spectrum (susceptibility, diagnostic, monitoring, prognostic, predictive, safety, and response) and for endpoints that reflect meaningful short- and long-term outcomes in pediatric populations.
Is this program designed to be run by a single organization acting alone?
No. A central theme is that no single organization can solve pediatric trial challenges alone. The opportunity is framed around broad stakeholder consensus and coordinated, network-based solutions.
What stakeholder efforts influenced this network concept?
The opportunity points to a 2014 stakeholder forum convened by the American Academy of Pediatrics (supported by an unrestricted PhRMA grant) where clinicians, researchers, regulators, patient advocates, parents, industry, and disease-focused networks discussed establishing a coordinated Global Pediatric Clinical Trials Network. It also builds on subsequent work by the Critical Path Institute, which launched the Pediatric Trials Consortium.
How is the Pediatric Trials Consortium Advisory Report used in this program?
The FDA expects applicants to align their proposed network with findings and recommendations from the Pediatric Trials Consortium Advisory Report, treating it as the blueprint for how the network should operate and deliver value.
What practical services or value is the network expected to provide?
The network is envisioned as a go-to resource for pediatric product development, offering best practices, improved protocol design, training and education, and hands-on administrative tools that reduce burdens for investigators and sponsors. It is also described as providing expert, independent advice, streamlining systems and processes, raising trial quality, and shortening timelines.
What is meant by a "global set of pre-qualified, trial-ready pediatric sites"?
The notice describes a key deliverable: coordinating and managing a global set of pre-qualified sites that are ready to run pediatric trials, including the staff and infrastructure needed for reliable execution. This is intended to improve recruitment and operational performance, particularly for rare diseases where eligible patients can be difficult to find.
What specific capabilities does the FDA expect applicants (awardees) to demonstrate or develop?
The solicitation calls for applicants to show they have developed, or have credible plans to develop: feasibility assessment reports; educational programming and standardized training; streamlined processes and efficient systems to improve trial quality, efficiency, and timeliness; a site selection tool; core network infrastructure; and dedicated pediatric research staff.
What are feasibility assessment reports in the context of this opportunity?
Feasibility assessment reports are described as a capability the network should have (or plan to develop) to help determine whether proposed pediatric trials can realistically be executed.
What governance and coordination elements are described in the notice?
The opportunity highlights governance and coordination elements including: independent advisory functions with robust stakeholder engagement; mechanisms for sharing information across the network; a centralized approach to institutional review board (IRB) review to reduce duplicative administrative work; and a core set of performance metrics to measure value creation for stakeholders.
What is the role of an independent advisory function?
The FDA describes the network as providing expert, independent advice to investigators and emphasizes that advisory functions should be supported by robust stakeholder engagement so that advice and priorities reflect inclusive input from academia, industry, parent and patient groups, and government agencies.
Does the opportunity mention centralizing IRB review?
Yes. It explicitly highlights a centralized approach to institutional review board review as a way to reduce duplicative administrative work.
How will the network measure whether it is creating value?
The notice calls for a core set of performance metrics to measure value creation for stakeholders.
What standards and methods should the network be familiar with?
The FDA expects the network to operate with strong knowledge of regulatory standards and modern, innovative clinical research methods.
Is the network intended to support rare disease pediatric trials?
Yes. Recruitment difficulties are called out as a frequent reason pediatric trials stall or fail, especially for rare diseases. The network is expected to improve recruitment through trial-ready sites and better coordinated infrastructure, and it encourages designs and approaches proven in rare disease research.
What is the award ceiling for this opportunity?
The opportunity listed an award ceiling of $2,000,000.
How many awards were expected?
The opportunity stated an expectation of one award.
Who is eligible to apply, based on the notice summary provided?
Eligibility was broad and included: federally recognized tribal governments and organizations; state and local governments; public and private universities; nonprofits (with and without 501(c)(3) status); for-profit organizations (including small businesses); and individuals, subject to any additional eligibility clarifications in the full announcement.
When was the opportunity originally posted and when was it originally due?
The original posting date was June 26, 2017, and the original closing date was August 22, 2017.
What kinds of products is the network intended to support (drugs, biologics, devices)?
The notice references generating regulatory-quality data for pediatric labeling across drugs, biologics, and devices.
What does "regulatory-quality data" mean in the context provided?
Within the provided description, it refers to data generated through a sustainable system that is capable of supporting pediatric labeling, implying consistent quality, regulatory standards awareness, and reliable trial execution across the network.
What does the opportunity say about training and education?
The FDA expects plans for educational programming and standardized training as part of the network infrastructure, with the goal of improving trial quality and operational consistency across participating sites.
How does the program intend to reduce burdens for investigators and sponsors?
The network is expected to offer hands-on administrative tools, streamline systems and processes, centralize or reduce duplicative review functions (such as IRB review), and provide operational support (including site readiness and staffing) to shorten timelines and improve consistency and quality.
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