Duke University awarded $2.4M contract for NICHD's Pediatric Trials Network core functions
Contract Overview
Contract Amount: $2,419,228 ($2.4M)
Contractor: Duke University
Awarding Agency: Department of Health and Human Services
Start Date: 2025-06-04
End Date: 2026-06-03
Contract Duration: 364 days
Daily Burn Rate: $6.6K/day
Competition Type: FULL AND OPEN COMPETITION
Pricing Type: COST NO FEE
Sector: R&D
Official Description: NICHD: R&D: BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) PEDIATRIC TRIALS NETWORK (PTN): CORE FUNCTION ACTIVITIES - THE CONTRACTOR SHALL ESTABLISH AND MAINTAIN CENTRALIZED TEAMS OF EXPERTS WHO WILL DEVELOP PROTOCOLS AND INFORMED CONSENT FORMS AND
Place of Performance
Location: DURHAM, DURHAM County, NORTH CAROLINA, 27705
Plain-Language Summary
Department of Health and Human Services obligated $2.4 million to DUKE UNIVERSITY for work described as: NICHD: R&D: BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) PEDIATRIC TRIALS NETWORK (PTN): CORE FUNCTION ACTIVITIES - THE CONTRACTOR SHALL ESTABLISH AND MAINTAIN CENTRALIZED TEAMS OF EXPERTS WHO WILL DEVELOP PROTOCOLS AND INFORMED CONSENT FORMS AND Key points: 1. Contract supports critical research infrastructure for pediatric drug development. 2. Focus on developing protocols and informed consent forms for clinical trials. 3. Long-term commitment to advancing pediatric pharmaceutical research. 4. Geographic focus on North Carolina for core operations. 5. Contract value appears reasonable for specialized research support services.
Value Assessment
Rating: good
The contract value of $2.4 million for a one-year period for core functions of a pediatric trials network appears reasonable given the specialized nature of the work. Benchmarking against similar R&D support contracts for large-scale clinical networks suggests this is within expected parameters. The 'Cost No Fee' (NC) contract type indicates that the contractor will be reimbursed for allowable costs, which is common for research-oriented agreements where precise final costs can be difficult to predict upfront.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. This competitive process is expected to drive fair pricing and ensure the selection of the most capable contractor. The specific number of bidders is not provided, but the method of competition suggests a robust evaluation process.
Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to more cost-effective solutions and prevent price gouging.
Public Impact
Benefits children by facilitating the development of safe and effective medications. Services include the development of essential research protocols and consent forms. Geographic impact is centered in North Carolina where Duke University is located. Supports a network of experts crucial for pediatric clinical research.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Potential for scope creep if core functions expand beyond initial definition.
- Reliance on a single contractor for critical network infrastructure could pose a risk if performance falters.
Positive Signals
- Duke University has a strong track record in research and development.
- The contract is for essential support functions, indicating a stable need.
- Full and open competition suggests a well-vetted selection process.
Sector Analysis
This contract falls within the Research and Development sector, specifically focusing on life sciences. The market for specialized clinical trial support services is competitive, with academic institutions and contract research organizations (CROs) being key players. The National Institutes of Health (NIH) is a major funder of such research, with significant annual spending allocated to advancing medical knowledge and treatments, particularly in areas like pediatric health.
Small Business Impact
This contract does not appear to involve a small business set-aside. As a large research institution, Duke University is unlikely to be considered a small business. There is no explicit mention of subcontracting requirements for small businesses, though it is possible that Duke may engage small businesses for specific support services as part of their overall project execution.
Oversight & Accountability
Oversight is likely managed by the National Institutes of Health (NIH) through program managers and contracting officers. Accountability measures would be tied to the successful completion of milestones and deliverables outlined in the contract. Transparency is generally maintained through federal contract databases, though specific performance metrics may not be publicly detailed.
Related Government Programs
- Pediatric Drug Development Programs
- Clinical Trial Networks
- National Institutes of Health Research Grants
- Best Pharmaceuticals for Children Act (BPCA)
Risk Flags
- Potential for delays in protocol development.
- Reliance on key personnel expertise.
- Ensuring compliance with evolving pediatric research regulations.
Tags
health-and-human-services, national-institutes-of-health, research-and-development, pediatric-trials, clinical-research, protocol-development, informed-consent, full-and-open-competition, cost-no-fee, north-carolina, duke-university, delivery-order
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $2.4 million to DUKE UNIVERSITY. NICHD: R&D: BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) PEDIATRIC TRIALS NETWORK (PTN): CORE FUNCTION ACTIVITIES - THE CONTRACTOR SHALL ESTABLISH AND MAINTAIN CENTRALIZED TEAMS OF EXPERTS WHO WILL DEVELOP PROTOCOLS AND INFORMED CONSENT FORMS AND
Who is the contractor on this award?
The obligated recipient is DUKE UNIVERSITY.
Which agency awarded this contract?
Awarding agency: Department of Health and Human Services (National Institutes of Health).
What is the total obligated amount?
The obligated amount is $2.4 million.
What is the period of performance?
Start: 2025-06-04. End: 2026-06-03.
What is Duke University's specific track record with NIH-funded pediatric research contracts?
Duke University has a substantial history of receiving NIH funding and managing complex research projects, including those related to pediatric health. While specific details for this exact contract's predecessor are not provided, Duke's School of Medicine and various research centers are well-established in clinical research. Their experience likely includes managing large-scale networks, developing study protocols, and ensuring regulatory compliance, which are all critical for the Pediatric Trials Network (PTN). A review of Duke's NIH Reporter profile or specific NICHD funding announcements would provide a more granular view of their past performance and the scale of their involvement in similar initiatives.
How does the $2.4 million contract value compare to similar pediatric trial network support contracts?
The $2.4 million value for a one-year contract supporting core functions of a pediatric trials network is generally considered moderate. Large, multi-site clinical trial networks often require significant infrastructure support, including protocol development, data management, and regulatory coordination. Annual budgets for such core support can range from a few hundred thousand dollars for smaller networks or specific functions to several million dollars for comprehensive, long-term initiatives. Given that this contract covers 'core function activities' for the PTN, the value appears aligned with the scope of establishing and maintaining expert teams for protocol and consent form development, suggesting a reasonable benchmark.
What are the primary risks associated with this contract and how are they mitigated?
Key risks include potential delays in protocol development impacting trial timelines, challenges in recruiting and retaining expert personnel, and ensuring adherence to evolving regulatory requirements for pediatric research. Mitigation strategies likely involve robust project management by Duke University, clear communication channels with NICHD, and established processes for protocol review and approval. The 'Cost No Fee' contract type also allows for flexibility in addressing unforeseen research challenges, though it requires diligent cost tracking and justification by the contractor. Furthermore, the full and open competition process aims to select a contractor with a proven ability to manage these risks effectively.
How effective is the Pediatric Trials Network (PTN) in achieving its goals, and how does this contract contribute?
The effectiveness of the PTN is measured by its ability to facilitate the development and testing of safe and effective medications for children, addressing a critical gap in pediatric pharmacology. This contract directly contributes by ensuring the foundational elements – well-designed protocols and clear informed consent forms – are in place. High-quality protocols are essential for generating reliable data, while effective consent forms ensure ethical conduct and participant understanding. The PTN's success is vital for translating research findings into improved clinical practice for pediatric populations, ultimately benefiting child health outcomes.
What are the historical spending patterns for NICHD's support of pediatric clinical trial infrastructure?
NICHD has consistently invested in pediatric clinical trial infrastructure to address the lack of evidence-based treatments for many childhood diseases. Historical spending patterns show a commitment to supporting networks and research centers that can conduct rigorous trials. Funding often involves multi-year grants and contracts to ensure continuity and stability for complex research endeavors. While specific figures fluctuate based on research priorities and available funding, the overall trend indicates a sustained effort to bolster pediatric research capacity. This $2.4 million contract aligns with that ongoing investment strategy for essential network support functions.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE
Solicitation ID: 75N94024R00008
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 2200 W MAIN ST, DURHAM, NC, 27705
Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business, Higher Education (Private), Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $17,268,194
Exercised Options: $2,419,228
Current Obligation: $2,419,228
Actual Outlays: $1,534,871
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: NO
Parent Contract
Parent Award PIID: 75N94025D00003
IDV Type: IDC
Timeline
Start Date: 2025-06-04
Current End Date: 2026-06-03
Potential End Date: 2032-06-03 00:00:00
Last Modified: 2026-01-23
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