Duke University receives $24.3M for Clinical Trials Network, spanning nearly a decade
Contract Overview
Contract Amount: $24,341,294 ($24.3M)
Contractor: Duke University
Awarding Agency: Department of Health and Human Services
Start Date: 2005-04-29
End Date: 2014-04-28
Contract Duration: 3,286 days
Daily Burn Rate: $7.4K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 14
Pricing Type: COST NO FEE
Sector: R&D
Official Description: DATA AND STATISTICS CENTER FOR THE CLINICAL TRIALS NETWORK
Place of Performance
Location: DURHAM, DURHAM County, NORTH CAROLINA, 27705, UNITED STATES OF AMERICA
Plain-Language Summary
Department of Health and Human Services obligated $24.3 million to DUKE UNIVERSITY for work described as: DATA AND STATISTICS CENTER FOR THE CLINICAL TRIALS NETWORK Key points: 1. Contract awarded through full and open competition, suggesting a robust market. 2. Long duration indicates a sustained need for the services provided. 3. No small business set-aside noted, potentially limiting opportunities for smaller firms. 4. Focus on R&D in physical, engineering, and life sciences aligns with NIH mission. 5. Geographic location in North Carolina may concentrate economic benefits locally.
Value Assessment
Rating: fair
The contract value of $24.3 million over approximately 9 years represents an average annual spend of roughly $2.7 million. Benchmarking this against similar large-scale R&D contracts is challenging without more specific service details. However, the 'Cost No Fee' contract type suggests that the government is primarily reimbursing the contractor for allowable costs, which can sometimes lead to less price certainty compared to fixed-price contracts. Further analysis would require comparing the specific research activities and outcomes to other NIH-funded clinical trial networks.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit offers. This typically suggests a healthy competitive environment where multiple organizations vied for the contract. The presence of 14 bids (implied by 'no': 14) further supports this, suggesting significant interest and a broad range of potential providers. This level of competition is generally favorable for price discovery and ensuring the government receives competitive proposals.
Taxpayer Impact: A full and open competition process is beneficial for taxpayers as it increases the likelihood of obtaining services at a fair and reasonable price due to the pressure of multiple bidders. It also promotes innovation by allowing a wider pool of contractors to propose solutions.
Public Impact
The primary beneficiaries are patients and the medical research community who gain access to data and findings from the Clinical Trials Network. Services delivered include the management and operation of a network designed to conduct clinical trials, likely focusing on specific disease areas or treatments. The geographic impact is centered in North Carolina, where Duke University is located, but the research findings can have national and international implications. Workforce implications include employment for researchers, project managers, data analysts, and support staff at Duke University and potentially partner institutions.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Long contract duration could lead to potential cost overruns if not managed tightly.
- Cost-reimbursement contract type may offer less incentive for cost control compared to fixed-price awards.
- Lack of small business participation noted, potentially missing out on specialized innovation or cost efficiencies.
Positive Signals
- Awarded through full and open competition, indicating a competitive process.
- Significant duration suggests a stable and important program for the agency.
- Duke University's established research infrastructure likely provides a strong foundation for program execution.
Sector Analysis
This contract falls within the Research and Development sector, specifically focusing on clinical trials within the life sciences. The market for managing large-scale clinical trial networks is specialized, often dominated by major research institutions and contract research organizations (CROs). Spending in this area is driven by pharmaceutical and biotechnology advancements, as well as government initiatives to accelerate medical discoveries. Comparable spending benchmarks would involve looking at other large NIH grants or contracts awarded to academic medical centers for similar network coordination efforts.
Small Business Impact
The data indicates that this contract was not set aside for small businesses (ss: false, sb: false). This suggests that the scale and nature of the services required were likely beyond the typical capabilities or capacity of small businesses, or that the competition was open to all eligible firms regardless of size. Consequently, there may be limited direct subcontracting opportunities for small businesses unless Duke University proactively engages them. This could mean that the economic benefits related to this specific contract are less distributed within the small business ecosystem.
Oversight & Accountability
Oversight for this contract would primarily fall under the National Institutes of Health (NIH), a component of the Department of Health and Human Services (HHS). Mechanisms likely include regular progress reports, financial reviews, and site visits to ensure compliance with the terms of the 'Cost No Fee' award and the research objectives. Accountability rests with Duke University to manage funds appropriately and achieve research milestones. Transparency is typically managed through public dissemination of research findings, although the contract details themselves may not be fully public.
Related Government Programs
- NIH Clinical Center
- National Center for Advancing Translational Sciences (NCATS) programs
- Biomedical Advanced Research and Development Authority (BARDA) contracts
- National Institute of Allergy and Infectious Diseases (NIAID) research grants
Risk Flags
- Potential for cost overruns due to 'Cost No Fee' structure.
- Limited visibility into specific performance metrics and outcomes.
- Lack of small business participation may limit broader economic impact.
Tags
research-and-development, health-and-human-services, national-institutes-of-health, clinical-trials, cost-no-fee, full-and-open-competition, academic-institution, north-carolina, long-term-contract, biomedical-research
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $24.3 million to DUKE UNIVERSITY. DATA AND STATISTICS CENTER FOR THE CLINICAL TRIALS NETWORK
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 $24.3 million.
What is the period of performance?
Start: 2005-04-29. End: 2014-04-28.
What is the track record of Duke University in managing large-scale federal research contracts, particularly those related to clinical trials?
Duke University has a well-established reputation as a leading research institution and has historically managed numerous large federal grants and contracts, including those from NIH. Their extensive experience in clinical research, medical innovation, and large-scale project management suggests a strong capability to handle complex programs like the Clinical Trials Network. While specific details on past performance for this exact contract are not provided, Duke's overall federal contracting history, particularly with NIH, is generally robust, indicating a high likelihood of successful execution based on their institutional capacity and prior successes in similar endeavors.
How does the total contract value of $24.3 million compare to other similar R&D contracts managed by NIH for clinical trial networks?
The total value of $24.3 million over nearly nine years, averaging approximately $2.7 million annually, is a substantial but not extraordinary figure for a large-scale, long-term clinical trial network managed by NIH. NIH funds a wide array of research initiatives, and the cost of establishing and maintaining such networks can vary significantly based on the therapeutic area, the number of participating sites, and the complexity of the trials. Without specific details on the scope of work and the number of sites involved in this particular network, a direct comparison is difficult. However, this figure falls within a common range for major NIH-funded research infrastructure projects.
What are the primary risks associated with a 'Cost No Fee' contract type for a long-duration R&D project?
The primary risks associated with a 'Cost No Fee' (CNF) contract type, especially for a long-duration R&D project, revolve around cost control and potential overruns. In a CNF contract, the government reimburses the contractor for all allowable costs incurred, but the contractor does not receive a fee or profit. While this can be advantageous for the government in terms of initial cost certainty for R&D where outcomes are uncertain, it can reduce the contractor's incentive to manage costs rigorously. Risks include the potential for scope creep, inefficient resource allocation, and the government ultimately paying more than anticipated if costs escalate without corresponding increases in value or progress. Robust oversight and clear performance metrics are crucial to mitigate these risks.
What does the duration of this contract (over 9 years) imply about the nature of the research and the agency's commitment?
The contract's duration of over 9 years (3286 days) strongly implies that the research activities are long-term in nature, likely involving multi-year studies, follow-up observations, or the phased development and implementation of a complex network. Such extended timelines are common in biomedical research, where clinical trials can take many years to complete and yield meaningful results. This duration also signals a significant and sustained commitment from the National Institutes of Health (NIH) to the objectives of the Clinical Trials Network. It suggests that the program is considered strategically important and requires a stable, long-term funding and operational framework.
How might the geographic concentration in North Carolina impact the broader reach and diversity of the clinical trials conducted?
While the contract is managed by Duke University in North Carolina, the impact on the broader reach and diversity of clinical trials depends heavily on the network's design and operational protocols. If the network primarily involves Duke's facilities, it could limit geographic diversity of patient recruitment and research sites. However, large clinical trial networks often involve multiple collaborating institutions across different regions. If Duke serves as a central coordinating hub for a distributed network, the geographic concentration of the awardee does not necessarily limit the diversity of the trials themselves. The key factor is whether the network actively recruits participants and engages research sites from diverse geographic and demographic populations nationwide or globally.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences
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: N01DA52207
Offers Received: 14
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 0 DUKE UNIVERSITY, DURHAM, NC, 27708
Business Categories: Category Business, Not Designated a Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $24,341,294
Exercised Options: $24,341,294
Current Obligation: $24,341,294
Timeline
Start Date: 2005-04-29
Current End Date: 2014-04-28
Potential End Date: 2014-04-28 00:00:00
Last Modified: 2015-06-26
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