Duke University awarded $18.4M for clinical trials to combat antimicrobial resistance
Contract Overview
Contract Amount: $18,405,527 ($18.4M)
Contractor: Duke University
Awarding Agency: Department of Health and Human Services
Start Date: 2009-08-03
End Date: 2017-12-31
Contract Duration: 3,072 days
Daily Burn Rate: $6.0K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 10
Pricing Type: COST NO FEE
Sector: R&D
Official Description: TAS::75 0885::TAS TARGETED CLINICAL TRIALS TO REDUCE THE RISK OF ANTIMICROBIAL RESISTANCE
Place of Performance
Location: DURHAM, DURHAM County, NORTH CAROLINA, 27705
Plain-Language Summary
Department of Health and Human Services obligated $18.4 million to DUKE UNIVERSITY for work described as: TAS::75 0885::TAS TARGETED CLINICAL TRIALS TO REDUCE THE RISK OF ANTIMICROBIAL RESISTANCE Key points: 1. Contract value represents a significant investment in critical public health research. 2. Competition dynamics suggest a robust market for specialized clinical trial services. 3. Contract duration indicates a long-term commitment to addressing antimicrobial resistance. 4. Performance context is crucial for evaluating the effectiveness of these trials. 5. Sector positioning places this award within the vital biomedical research landscape.
Value Assessment
Rating: good
The contract value of $18.4 million over its period of performance appears reasonable for a large-scale, multi-year clinical trial initiative. Benchmarking against similar large-scale clinical trial contracts would provide a more precise value-for-money assessment. However, the Cost No Fee (CNF) contract type suggests that the contractor bears the financial risk, which can be a positive indicator for the government if the contractor is capable.
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. The presence of 10 bids suggests a healthy level of competition for this research area. This broad competition is generally expected to drive more competitive pricing and innovative solutions.
Taxpayer Impact: Full and open competition benefits taxpayers by ensuring that the government receives the best possible value through a wide range of offers and potentially lower prices due to market forces.
Public Impact
The primary beneficiaries are public health organizations and the general population, through advancements in combating antimicrobial resistance. Services delivered include conducting targeted clinical trials to identify and test interventions. Geographic impact is national, with potential global implications for public health. Workforce implications include employment for researchers, clinicians, and support staff involved in clinical trials.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Potential for cost overruns if research proves more complex than anticipated, though CNF mitigates direct government financial risk.
- Ensuring consistent data quality and adherence to trial protocols across the duration of the contract.
Positive Signals
- Award to a reputable institution (Duke University) suggests a strong likelihood of successful execution.
- The Cost No Fee (CNF) contract type places financial risk on the contractor, incentivizing efficient management.
- Long contract duration allows for in-depth research and development.
Sector Analysis
This contract falls within the broader Research and Development sector, specifically focusing on life sciences and biotechnology. The market for clinical trial services is substantial, driven by pharmaceutical companies, government agencies, and academic institutions. This award aligns with federal priorities to address critical public health threats like antimicrobial resistance, a growing global concern.
Small Business Impact
The provided data does not indicate any specific small business set-aside or subcontracting requirements for this contract. As a large research grant awarded to a major university, the primary focus is likely on the institution's research capabilities rather than small business participation. Further investigation into subcontracting plans would be needed to assess small business impact.
Oversight & Accountability
Oversight would typically be managed by the National Institutes of Health (NIH) program officials responsible for antimicrobial resistance research. Accountability measures would be tied to the achievement of research milestones and the quality of data produced. Transparency is generally maintained through public reporting of research findings and adherence to federal research ethics and data management standards.
Related Government Programs
- National Institutes of Health (NIH) Research Grants
- Centers for Disease Control and Prevention (CDC) Antimicrobial Resistance Initiatives
- Department of Defense (DoD) Medical Research Programs
Risk Flags
- Contract duration is lengthy, requiring sustained oversight.
- Cost No Fee contract type places financial risk on the contractor.
Tags
research-and-development, health-and-human-services, national-institutes-of-health, clinical-trials, antimicrobial-resistance, cost-plus-fixed-fee, definitive-contract, north-carolina, university-contractor, full-and-open-competition
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $18.4 million to DUKE UNIVERSITY. TAS::75 0885::TAS TARGETED CLINICAL TRIALS TO REDUCE THE RISK OF ANTIMICROBIAL RESISTANCE
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 $18.4 million.
What is the period of performance?
Start: 2009-08-03. End: 2017-12-31.
What is Duke University's track record in managing large-scale clinical trials, particularly in infectious diseases or antimicrobial resistance?
Duke University has a well-established reputation and extensive experience in conducting clinical trials across various therapeutic areas, including infectious diseases. Its School of Medicine and associated research centers are equipped with the infrastructure and expertise necessary for managing complex, multi-site clinical studies. Duke has a history of successfully competing for and managing significant federal research grants from agencies like NIH. While specific details on their track record solely in antimicrobial resistance clinical trials would require deeper analysis of their past awards and publications, their overall capacity in clinical research is considered strong, making them a suitable candidate for this type of award.
How does the $18.4 million award compare to other federal investments in antimicrobial resistance research?
The $18.4 million awarded to Duke University for targeted clinical trials represents a substantial, but not unprecedented, investment in the fight against antimicrobial resistance (AMR). Federal agencies like NIH and CDC allocate billions annually to biomedical research, with specific funding streams dedicated to AMR. For instance, NIH's National Institute of Allergy and Infectious Diseases (NIAID) funds numerous projects related to infectious diseases and resistance mechanisms. While this single contract is significant, it should be viewed within the context of a broader federal strategy that includes multiple research grants, public health surveillance programs, and policy initiatives aimed at combating AMR. Comparing it directly requires aggregating spending across various programs and agencies focused on AMR.
What are the primary risks associated with this Cost No Fee (CNF) contract type for clinical trials?
The primary risk associated with a Cost No Fee (CNF) contract type, especially for research and development like clinical trials, is that the contractor (Duke University) assumes all financial risk. If the research encounters unforeseen challenges, requires more resources than initially estimated, or fails to yield expected results, the contractor bears the cost without additional government reimbursement. For the government, the risk is less financial and more about the potential for project delays or failure to achieve objectives if the contractor is unable to sustain the effort. However, CNF contracts incentivize efficient management and realistic cost estimation by the contractor, as they are motivated to control costs to ensure profitability or avoid losses.
What specific types of clinical trials are being funded under this contract, and what are the expected outcomes?
The contract description 'TAS TARGETED CLINICAL TRIALS TO REDUCE THE RISK OF ANTIMICROBIAL RESISTANCE' indicates that the funding is for clinical trials specifically designed to find ways to lower the incidence or impact of infections caused by drug-resistant microbes. While the exact nature of the trials isn't detailed in the provided data, they could encompass a range of activities. This might include testing new diagnostic tools to identify resistant infections faster, evaluating novel therapeutic strategies (like phage therapy or new antibiotic combinations), assessing the effectiveness of infection control protocols in healthcare settings, or studying behavioral interventions to reduce antibiotic misuse. The expected outcomes would be evidence-based strategies and interventions that demonstrably reduce the risk and spread of antimicrobial resistance, ultimately preserving the effectiveness of existing antibiotics and developing new ones.
How has federal spending on antimicrobial resistance research evolved over the contract's duration (2009-2017)?
The contract period spans from 2009 to 2017. During this timeframe, federal spending on antimicrobial resistance (AMR) research saw a gradual but significant increase, reflecting growing global concern over the threat. Agencies like NIH and CDC consistently allocated funds towards AMR research, surveillance, and stewardship programs. While specific year-over-year figures for all federal AMR spending are complex to aggregate, this period witnessed the development of national action plans and increased emphasis on public-private partnerships to accelerate the discovery of new diagnostics, treatments, and vaccines. The funding awarded to Duke University aligns with this trend of sustained federal investment in addressing AMR.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: BASIC RESEARCH
Offers Received: 10
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 334 N BUILDING RESEARCH DR, DUKE UNIVERSITY, DURHAM, NC, 27708
Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business, Higher Education (Private)
Financial Breakdown
Contract Ceiling: $30,178,442
Exercised Options: $18,405,527
Current Obligation: $18,405,527
Contract Characteristics
Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED
Timeline
Start Date: 2009-08-03
Current End Date: 2017-12-31
Potential End Date: 2018-05-23 00:00:00
Last Modified: 2018-05-23
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