NIH awards $18M for biomedical clinical trial, with a significant 3,839-day duration

Contract Overview

Contract Amount: $17,955,230 ($18.0M)

Contractor: University of Alabama AT Birmingham

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: $4.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 15

Pricing Type: COST NO FEE

Sector: R&D

Official Description: BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE

Place of Performance

Location: BIRMINGHAM, JEFFERSON County, ALABAMA, 35233

State: Alabama Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $18.0 million to UNIVERSITY OF ALABAMA AT BIRMINGHAM for work described as: BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE Key points: 1. The contract's extended duration suggests a long-term research commitment, potentially indicating complex study requirements. 2. A single award for this amount highlights the specialized nature of the research and the contractor's unique capabilities. 3. The absence of small business involvement may point to the need for highly specialized expertise or large-scale infrastructure. 4. The 'Cost No Fee' contract type implies that the government reimburses allowable costs but does not pay an additional profit fee. 5. This award falls within the 'Research and Development in the Physical, Engineering, and Life Sciences' NAICS code, indicating a focus on scientific advancement.

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging without comparable long-term biomedical clinical trials. The 'Cost No Fee' structure means the government covers expenses but doesn't pay a profit margin, which can be cost-effective if managed well. However, the extended duration of nearly 11 years (3,839 days) raises questions about potential cost overruns and the efficiency of resource utilization over such a prolonged period. Further analysis would require understanding the specific milestones and deliverables tied to this extensive timeline.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting that multiple qualified bidders had the opportunity to submit proposals. The presence of 15 proposals indicates a competitive environment, which typically drives better pricing and innovation. This level of competition is generally favorable for the government and taxpayers, as it allows for the selection of the most capable offeror at the best value.

Taxpayer Impact: Full and open competition for this contract likely resulted in a more competitive price and ensured that taxpayer funds were used to secure the best possible research services.

Public Impact

The primary beneficiaries are patients who may benefit from advancements in understanding and treating systolic blood pressure. The services delivered involve conducting a complex biomedical clinical trial, contributing to scientific knowledge. The geographic impact is primarily within Alabama, where the University of Alabama at Birmingham is located, but the research findings have national and potentially global implications. The contract supports academic research and potentially specialized healthcare professionals involved in clinical trials.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The extended contract duration of over 10 years presents a risk of scope creep and potential cost increases if not meticulously managed.
The 'Cost No Fee' contract type, while potentially cost-saving, requires robust oversight to ensure that all reimbursed costs are reasonable and allocable.
The lack of specific performance metrics or outcome data in the provided summary makes it difficult to assess the true value and effectiveness of the research over time.

Positive Signals

The award was made under full and open competition, indicating a robust selection process and potentially competitive pricing.
The large number of proposals received (15) suggests significant interest and a healthy market for this type of specialized research.
The contract is with a known academic institution (University of Alabama at Birmingham), implying a level of established research capability.

Sector Analysis

This contract falls under the Research and Development (R&D) sector, specifically within life sciences. The market for biomedical clinical trials is substantial, driven by pharmaceutical companies, government agencies like NIH, and academic institutions. This contract represents a significant investment in understanding and potentially treating a widespread health condition, aligning with broader government priorities in public health and medical innovation. Comparable spending benchmarks would typically involve analyzing other large-scale, multi-year clinical trials funded by federal agencies.

Small Business Impact

The data indicates that this contract was not set aside for small businesses (ss: false, sb: false). This is common for large-scale, long-term research projects that require extensive infrastructure, specialized expertise, and significant financial resources typically found in larger academic institutions or established research organizations. There are no explicit subcontracting implications mentioned, but it's unlikely that small businesses would be primary subcontractors on such a specialized, long-duration project.

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. As a 'Cost No Fee' contract, rigorous financial oversight is crucial to ensure that all reimbursed costs are allowable, reasonable, and allocable to the contract. The long duration necessitates continuous monitoring of progress against research milestones and adherence to ethical and scientific standards. Transparency would be facilitated through regular reporting requirements from the contractor and potential public dissemination of research findings.

Related Government Programs

National Institutes of Health Research Grants
Clinical Trial Funding
Biomedical Research Initiatives
Public Health Research Programs

Risk Flags

Long Contract Duration
Cost Reimbursement Contract Type
Potential for Cost Overruns
Need for Robust Oversight

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $18.0 million to UNIVERSITY OF ALABAMA AT BIRMINGHAM. BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE

Who is the contractor on this award?

The obligated recipient is UNIVERSITY OF ALABAMA AT BIRMINGHAM.

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 $18.0 million.

What is the period of performance?

Start: 2009-09-15. End: 2020-03-20.

What specific research questions is this clinical trial designed to answer regarding systolic blood pressure?

The provided data indicates the contract is for a 'BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE,' but does not detail the specific research questions. Typically, such trials aim to investigate the efficacy and safety of interventions (drugs, devices, lifestyle changes), understand the underlying mechanisms of hypertension, identify risk factors, or compare different treatment protocols. The extensive duration (3,839 days) suggests the trial likely involves long-term follow-up, potentially assessing chronic effects, adherence, or the development of secondary outcomes. Further details would be found in the Statement of Work (SOW) or the original solicitation documents, outlining primary and secondary endpoints, patient populations, and study design.

How does the total award amount of $17.96 million compare to other NIH-funded clinical trials of similar scope and duration?

Comparing the $17.96 million award requires context on the scope and duration. A nearly 11-year duration (3,839 days) is substantial for a clinical trial. While $18 million is a significant sum, large-scale, multi-center, long-term clinical trials, especially those involving complex interventions or rare diseases, can easily exceed this amount, sometimes reaching hundreds of millions of dollars. NIH funding varies widely based on therapeutic area, phase of research, and number of participants. To benchmark effectively, one would need to identify comparable trials funded by NIH within the last decade, focusing on those studying cardiovascular conditions, with similar patient recruitment targets and follow-up periods. The 'Cost No Fee' structure also influences the total outlay, as it covers direct and indirect costs without a profit margin.

What are the key risks associated with a 'Cost No Fee' contract type for a long-duration research project?

The primary risk with a 'Cost No Fee' (CNF) contract is ensuring that the government only reimburses legitimate, allowable, and reasonable costs without any contractor profit. For a long-duration research project like this (3,839 days), risks include: 1) Inadequate cost controls by the contractor, leading to inflated expenses that are still reimbursable. 2) Difficulty in accurately forecasting costs over an extended period, potentially leading to budget shortfalls or unexpected increases. 3) Potential for the contractor to lack strong incentives for efficiency, as profit is not at stake. Robust government oversight, detailed cost accounting standards, and regular audits are critical to mitigate these risks and ensure fiscal responsibility. The contractor must maintain meticulous records to justify all incurred costs.

Given the 'full and open competition' and 15 proposals, what does this suggest about the contractor's (University of Alabama at Birmingham) competitive advantage?

The fact that the University of Alabama at Birmingham (UAB) won a contract after 'full and open competition' with 15 proposals suggests they possessed a significant competitive advantage. This could stem from several factors: specialized expertise in the specific area of systolic blood pressure research, a strong track record of successful clinical trials, unique facilities or equipment, a highly qualified research team, or a compelling research plan and methodology outlined in their proposal. UAB may have also offered a more cost-effective approach or demonstrated superior technical capabilities compared to the other 14 bidders. Winning under such competitive conditions indicates that their proposal was deemed the best value overall by the NIH evaluators.

What are the potential implications of the 3,839-day duration on the scientific relevance and applicability of the research findings?

A duration of 3,839 days (over 10 years) for a clinical trial has significant implications. Scientifically, it allows for the study of long-term effects, chronic disease progression, adherence challenges, and the sustainability of interventions, which shorter trials cannot capture. This can lead to more robust and generalizable findings. However, it also poses risks: the scientific landscape can evolve rapidly, potentially making initial research questions or methodologies outdated by the study's end. Furthermore, participant retention over such a long period is challenging, potentially biasing results. The applicability of findings depends on whether the research remains relevant to current clinical practice and patient needs by the time results are published. Careful planning and adaptive trial designs can help mitigate some of these risks.

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: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 701 S 20TH STREET, BIRMINGHAM, AL, 35294

Business Categories: Category Business, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business

Financial Breakdown

Contract Ceiling: $17,955,230

Exercised Options: $17,955,230

Current Obligation: $17,955,230

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Timeline