Duke University Awarded $11.99M for Community Acquired Pneumonia Clinical Trial
Contract Overview
Contract Amount: $11,990,437 ($12.0M)
Contractor: Duke University
Awarding Agency: Department of Health and Human Services
Start Date: 2015-06-05
End Date: 2024-12-31
Contract Duration: 3,497 days
Daily Burn Rate: $3.4K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 1
Pricing Type: COST NO FEE
Sector: R&D
Official Description: IGF::OT::IGF1300017I DUKE UNIVERSITY; TASK ORDER HHSN27200008-14-0053.A1B1C1D1.0026- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL IN ADULTS WITH COMMUNITY ACQUIRED PNEUMONIA; BASE $141,485, OPTION 1 $67,837, OPTION 2 $4,049,893, AND OPTION 4 $798,412
Place of Performance
Location: DURHAM, DURHAM County, NORTH CAROLINA, 27705
Plain-Language Summary
Department of Health and Human Services obligated $12.0 million to DUKE UNIVERSITY for work described as: IGF::OT::IGF1300017I DUKE UNIVERSITY; TASK ORDER HHSN27200008-14-0053.A1B1C1D1.0026- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL IN ADULTS WITH COMMUNITY ACQUIRED PNEUMONIA; BASE $141,485, OPTION 1 $67,837, OPTION 2 $4,049,893, AND OPTION 4 $798,412 Key points: 1. The contract supports a critical clinical trial for community-acquired pneumonia, a significant public health concern. 2. Awarded to Duke University, a known research institution, suggesting a competitive selection process. 3. The long duration (nearly 10 years) and substantial funding raise questions about project scope and potential cost overruns. 4. Spending falls within the Research and Development sector, aligning with NIH's mission.
Value Assessment
Rating: questionable
The total award of $11.99M over nearly a decade for a clinical trial appears high, especially considering the base amount was relatively small. Benchmarking against similar large-scale, multi-year clinical trials would be necessary for a definitive assessment.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, indicating multiple entities had the opportunity to bid. This method generally promotes competitive pricing, but the final negotiated price for such a long-term, complex project requires further scrutiny.
Taxpayer Impact: Taxpayer funds are supporting critical medical research, which has the potential for significant long-term public health benefits. However, the high total cost necessitates efficient project management to ensure value for money.
Public Impact
Potential for new treatments or improved understanding of community-acquired pneumonia. Advances medical knowledge and contributes to public health preparedness. Supports academic research and the development of clinical trial expertise.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Long contract duration may indicate scope creep or inefficient management.
- High total cost for a single clinical trial warrants scrutiny.
- Lack of specific performance metrics in the provided data.
Positive Signals
- Supports critical public health research.
- Awarded through full and open competition.
- Involves a reputable research institution.
Sector Analysis
This contract falls under the Research and Development in the Physical, Engineering, and Life Sciences sector. Spending in this area is crucial for scientific advancement but can be subject to long timelines and unpredictable outcomes. Benchmarks for similar large-scale clinical trials are essential for cost evaluation.
Small Business Impact
The data indicates this contract was awarded to Duke University, a large research institution. There is no indication of small business participation in this specific award, which is common for large-scale, specialized research projects.
Oversight & Accountability
Oversight would typically be managed by the National Institutes of Health (NIH) through regular reporting and milestone reviews. The long duration necessitates consistent monitoring to ensure adherence to the research protocol and budget.
Related Government Programs
- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Department of Health and Human Services Contracting
- National Institutes of Health Programs
Risk Flags
- High total contract value.
- Extended contract duration (nearly 10 years).
- Potential for cost overruns due to long-term nature.
- Lack of detailed performance metrics in the provided data.
- Complexity of managing a multi-year clinical trial.
Tags
research-and-development-in-the-physical, department-of-health-and-human-services, nc, delivery-order, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $12.0 million to DUKE UNIVERSITY. IGF::OT::IGF1300017I DUKE UNIVERSITY; TASK ORDER HHSN27200008-14-0053.A1B1C1D1.0026- A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL IN ADULTS WITH COMMUNITY ACQUIRED PNEUMONIA; BASE $141,485, OPTION 1 $67,837, OPTION 2 $4,049,893, AND OPTION 4 $798,412
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 $12.0 million.
What is the period of performance?
Start: 2015-06-05. End: 2024-12-31.
What is the projected impact of this clinical trial on patient outcomes for community-acquired pneumonia?
The trial aims to evaluate a specific intervention's efficacy and safety in adults with community-acquired pneumonia. Positive results could lead to new treatment guidelines, improved patient recovery rates, reduced hospitalizations, and potentially lower mortality associated with this common and serious infection. The long-term impact hinges on the trial's successful completion and the subsequent adoption of any proven interventions.
What are the primary risks associated with the long duration and high cost of this contract?
The primary risks include potential scope creep, leading to increased costs beyond the initial estimates. Inefficient project management over the extended period could inflate expenses. Furthermore, scientific or clinical relevance might diminish over time if research priorities shift or if preliminary findings suggest the intervention is not viable, leading to wasted taxpayer funds without achieving desired outcomes.
How does the cost of this trial compare to similar large-scale, multi-year clinical trials for respiratory illnesses?
Without specific details on the trial's design, patient population size, and intervention complexity, a direct cost comparison is difficult. However, $11.99 million over nearly a decade for a randomized, double-blind, placebo-controlled trial is within the expected range for significant clinical research. Benchmarking against NIH-funded trials for similar conditions would provide a more accurate assessment of cost-effectiveness.
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: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY
Solicitation ID: NIAIDDMIDNIHAI2012144
Offers Received: 1
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 2200 W MAIN ST, 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: $15,486,127
Exercised Options: $11,990,437
Current Obligation: $11,990,437
Actual Outlays: $4,896,617
Subaward Activity
Number of Subawards: 3
Total Subaward Amount: $4,354,875
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: NO
Parent Contract
Parent Award PIID: HHSN272201300017I
IDV Type: IDC
Timeline
Start Date: 2015-06-05
Current End Date: 2024-12-31
Potential End Date: 2024-12-31 00:00:00
Last Modified: 2025-09-23
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