NIH awards $19.5M for Biomedical Clinical Trial on Systolic Blood Pressure to Case Western Reserve University
Contract Overview
Contract Amount: $19,535,881 ($19.5M)
Contractor: Case Western Reserve University
Awarding Agency: Department of Health and Human Services
Start Date: 2009-09-15
End Date: 2020-03-20
Contract Duration: 3,839 days
Daily Burn Rate: $5.1K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 15
Pricing Type: FIRM FIXED PRICE
Sector: R&D
Official Description: TAS::75 4554::TAS BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE
Place of Performance
Location: CLEVELAND, CUYAHOGA County, OHIO, 44106
State: Ohio Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $19.5 million to CASE WESTERN RESERVE UNIVERSITY for work described as: TAS::75 4554::TAS BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE Key points: 1. Spending focuses on R&D in life sciences, a critical area for public health. 2. The contract was awarded through full and open competition, suggesting a competitive bidding process. 3. A firm fixed-price contract type helps manage cost certainty for this long-term study. 4. The duration of the award (over 10 years) indicates a significant, multi-phase research project.
Value Assessment
Rating: good
The contract value of $19.5M over 10 years averages approximately $1.95M annually. This appears reasonable for a large-scale, multi-year clinical trial, though specific benchmarks for similar NIH-funded trials would provide more precise comparison.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The award was made under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. This method generally promotes competitive pricing and ensures the government receives the best value.
Taxpayer Impact: Taxpayer funds are directed towards critical medical research, potentially leading to advancements in public health and treatment for hypertension.
Public Impact
Potential for significant advancements in understanding and treating systolic blood pressure. Long-term investment in health research could yield substantial public health benefits. Supports academic research institutions and contributes to scientific knowledge base.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Long contract duration may present risks if research objectives shift or technology evolves rapidly.
- Fixed-price contract might not fully account for unforeseen research complexities or cost overruns.
Positive Signals
- Focus on a critical health issue with high public impact.
- Competitive award process suggests potential for value.
- Clear research objective for a defined period.
Sector Analysis
This spending falls under the Research and Development sector, specifically focusing on life sciences. Benchmarks for NIH-funded clinical trials of this magnitude are typically in the multi-million dollar range over several years, aligning with this award.
Small Business Impact
The data does not indicate any specific involvement or set-aside for small businesses in this contract. The awardee is a university, suggesting a focus on large-scale research capabilities rather than small business participation.
Oversight & Accountability
The National Institutes of Health (NIH) is responsible for overseeing this research grant. Standard NIH oversight mechanisms, including progress reports and scientific reviews, would be in place to ensure accountability and proper use of funds.
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
- Long contract duration (over 10 years).
- Firm fixed-price contract in a research setting.
- Potential for evolving research needs and methodologies.
- Lack of explicit small business participation noted.
Tags
research-and-development-in-the-physical, department-of-health-and-human-services, oh, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $19.5 million to CASE WESTERN RESERVE UNIVERSITY. TAS::75 4554::TAS BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE
Who is the contractor on this award?
The obligated recipient is CASE WESTERN RESERVE 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 $19.5 million.
What is the period of performance?
Start: 2009-09-15. End: 2020-03-20.
What is the specific scientific objective of this clinical trial, and how will its success be measured?
The specific scientific objective is to study systolic blood pressure. Success measurement would likely involve predefined clinical endpoints, such as achieving statistically significant reductions in blood pressure within study cohorts, identifying key biomarkers, or evaluating the efficacy of specific interventions. Detailed protocols and interim analyses would outline these metrics.
Given the 10-year duration, what mechanisms are in place to manage potential scope creep or adapt to evolving research methodologies?
Long-term contracts often include provisions for annual reviews, phased funding, and modification clauses. The NIH likely employs a phased approach, requiring Case Western Reserve University to meet specific milestones before subsequent funding tranches are released. Regular scientific advisory board meetings would also allow for adjustments based on emerging data or methodological advancements.
How does the firm fixed-price structure mitigate risks for both the government and the contractor in a complex, long-term research project?
For the government, a firm fixed-price contract provides cost certainty, protecting against budget overruns if the scope remains stable. For the contractor, it offers profit potential if efficiencies are found. However, in R&D, it can shift risk to the contractor if unforeseen challenges significantly increase costs beyond the fixed price, potentially impacting research progress if not managed carefully.
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: NEGOTIATED PROPOSAL/QUOTE
Offers Received: 15
Pricing Type: FIRM FIXED PRICE (J)
Evaluated Preference: NONE
Contractor Details
Address: 10900 EUCLID AVE, CLEVELAND, OH, 44106
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: $19,535,881
Exercised Options: $19,535,881
Current Obligation: $19,535,881
Contract Characteristics
Multi-Year Contract: Yes
Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED
Cost or Pricing Data: NO
Timeline
Start Date: 2009-09-15
Current End Date: 2020-03-20
Potential End Date: 2020-03-20 00:00:00
Last Modified: 2021-07-01
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