NIH awards $11M for clinical research network focused on acute lung injury and ARDS

Contract Overview

Contract Amount: $11,062,845 ($11.1M)

Contractor: THE General Hospital Corporation

Awarding Agency: Department of Health and Human Services

Start Date: 2005-09-29

End Date: 2015-03-19

Contract Duration: 3,458 days

Daily Burn Rate: $3.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 21

Pricing Type: COST NO FEE

Sector: R&D

Official Description: CLINICAL COORDINATING CENTER FOR A CLINICAL RESEARCH NETWORK FOR THE TREATMENT OF ACUTE LUNG INJURY (ALI) AND THE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

Place of Performance

Location: BOSTON, SUFFOLK County, MASSACHUSETTS, 02114, UNITED STATES OF AMERICA

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $11.1 million to THE GENERAL HOSPITAL CORPORATION for work described as: CLINICAL COORDINATING CENTER FOR A CLINICAL RESEARCH NETWORK FOR THE TREATMENT OF ACUTE LUNG INJURY (ALI) AND THE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) Key points: 1. Contract supports critical research into severe respiratory conditions. 2. Long-term award indicates sustained need for this specialized network. 3. Performance period spans nearly a decade, suggesting stable program execution. 4. Focus on a specific medical niche highlights targeted federal investment. 5. The award value is substantial, reflecting the complexity of coordinating multi-site research.

Value Assessment

Rating: good

The total award of approximately $11 million over a 10-year period for a clinical coordinating center is a significant investment. Benchmarking this against similar large-scale, multi-year clinical research network coordination contracts is challenging due to the specialized nature of the ALI/ARDS focus. However, the cost-no-fee contract type suggests that the primary consideration was the expertise and infrastructure of the awardee rather than direct profit margins. The sustained funding over a long duration implies a consistent need and potentially good value for the services rendered in advancing critical medical research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified organizations had the opportunity to bid. The presence of 21 proposals suggests a robust competitive environment for this specialized service. A high number of bidders generally leads to better price discovery and encourages contractors to offer competitive terms and innovative solutions, which is beneficial for the government and taxpayers.

Taxpayer Impact: The full and open competition process for this contract likely resulted in a more favorable price for the government compared to a sole-source award. It ensures that taxpayer funds are used efficiently by leveraging market competition to secure the best possible value for essential research coordination services.

Public Impact

Patients suffering from Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) benefit from advancements in treatment and understanding. The research network facilitates the collection and analysis of critical data to improve medical interventions. Healthcare providers and researchers gain access to a coordinated network for clinical trials and data sharing. The project supports the broader public health goal of combating severe respiratory diseases. The contract indirectly supports a specialized segment of the medical research workforce.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep in long-term research projects.
Reliance on a single coordinating center could pose a risk if operations are disrupted.
Ensuring continued innovation and adaptation in research methodologies over a decade.

Positive Signals

Award to a well-established institution (The General Hospital Corporation) suggests strong capabilities.
Long contract duration indicates successful past performance and program stability.
Full and open competition ensures a wide pool of potential solutions and competitive pricing.
The specific focus on ALI/ARDS addresses a critical unmet medical need.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. The market for clinical coordinating centers is specialized, often involving academic medical centers or dedicated research organizations with proven expertise in managing complex, multi-site clinical trials. The approximately $11 million award over ten years is substantial for a single coordinating center, reflecting the significant administrative and scientific oversight required for a national research network. Comparable spending benchmarks would typically be found within NIH's broader portfolio of large clinical trial network grants.

Small Business Impact

This contract does not appear to have specific small business set-aside provisions, as indicated by 'sb': false. The nature of coordinating a national clinical research network typically requires extensive infrastructure, established research protocols, and significant institutional capacity, which are more commonly found in larger organizations. Subcontracting opportunities for small businesses might exist in areas like data management, statistical analysis, or specialized equipment, but the primary awardee is a large entity.

Oversight & Accountability

Oversight for this contract would primarily be managed by the National Institutes of Health (NIH), the awarding agency. As a cost-no-fee contract, financial oversight focuses on ensuring that funds are used for approved research activities. Performance oversight would involve regular reviews of research progress, data quality, and adherence to protocols. Transparency is generally maintained through public reporting of research findings and NIH's public databases. The Inspector General of the Department of Health and Human Services would have jurisdiction over any potential fraud, waste, or abuse.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Clinical Trial Networks
Acute Lung Injury Research
ARDS Treatment Studies
Medical Research Coordinating Centers

Risk Flags

Long contract duration may increase risk of scientific obsolescence.
Reliance on a single coordinating entity could pose operational risks.
Potential for scope creep in long-term research projects.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.1 million to THE GENERAL HOSPITAL CORPORATION. CLINICAL COORDINATING CENTER FOR A CLINICAL RESEARCH NETWORK FOR THE TREATMENT OF ACUTE LUNG INJURY (ALI) AND THE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

Who is the contractor on this award?

The obligated recipient is THE GENERAL HOSPITAL CORPORATION.

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 $11.1 million.

What is the period of performance?

Start: 2005-09-29. End: 2015-03-19.

What is the track record of The General Hospital Corporation in managing large-scale clinical research networks?

The General Hospital Corporation, often associated with Massachusetts General Hospital, has a long-standing reputation for excellence in medical research and clinical care. While specific details on their track record managing NIH-funded clinical coordinating centers are not provided in the abbreviated data, their status as a major academic medical institution suggests significant experience in coordinating complex research initiatives. They are known for their robust infrastructure, experienced research staff, and established relationships within the medical research community, which are critical for successfully managing multi-site clinical trials. Further investigation into their specific portfolio of past grants and contracts would provide a more definitive assessment of their experience in this precise role.

How does the $11 million award compare to other clinical coordinating center contracts for similar research areas?

Direct comparison of the $11 million award for this specific ALI/ARDS clinical coordinating center to other contracts is difficult without more granular data on similar specialized networks. However, the duration of nearly 10 years (3458 days) for this award suggests a substantial, long-term commitment. NIH typically funds large clinical networks, and coordinating centers for such networks can range from several million to tens of millions of dollars over their lifespan, depending on the scope, number of sites, and complexity of the research. The cost-no-fee structure implies that the award is based on the value of the services and expertise provided rather than a profit margin, which is common for research infrastructure awards. The sustained funding indicates the perceived value and necessity of this coordinating function for advancing research in ALI and ARDS.

What are the primary risks associated with a decade-long contract for a clinical research coordinating center?

A primary risk associated with a decade-long contract for a clinical research coordinating center is the potential for scientific obsolescence or shifts in research priorities. Medical science evolves rapidly, and a network designed today might need significant adaptation to remain relevant over ten years. Another risk is the potential for contractor performance degradation over time, or the departure of key personnel, which could disrupt the continuity and quality of coordination. Furthermore, long-term reliance on a single entity could lead to complacency or a lack of competitive pressure to innovate. Ensuring robust oversight, flexibility in adapting research protocols, and contingency planning for personnel changes are crucial mitigation strategies.

How effective is the 'full and open competition' process in ensuring value for taxpayer money in specialized research contracts?

The 'full and open competition' process is generally considered the most effective method for ensuring value for taxpayer money, even in specialized research contracts. By allowing all responsible sources to submit proposals, it fosters a competitive environment that drives down costs and encourages innovation. For a specialized service like a clinical coordinating center, this process ensures that the government can identify and select the most capable and cost-effective provider from a wide pool of potential candidates. The presence of 21 proposals in this case indicates strong interest and a healthy competition, which typically leads to better pricing and service terms than a sole-source or limited competition award. This maximizes the return on investment for public funds allocated to critical research.

What are the implications of the 'Cost No Fee' (CNF) contract type for this research award?

The 'Cost No Fee' (CNF) contract type signifies that the contractor, The General Hospital Corporation, will be reimbursed for its allowable costs incurred in performing the contract, but will not receive any additional fee or profit. This type of contract is typically used when the work is of such a nature that it cannot be easily evaluated for profit potential, or when the primary objective is to secure the performance of research or development work by organizations that are not primarily motivated by profit. For this clinical coordinating center, it suggests that the NIH prioritized the expertise, infrastructure, and research capabilities of the institution over a profit-driven motive. It ensures that funds are directed towards the direct costs of conducting the research coordination activities, potentially leading to greater efficiency and focus on the scientific mission.

What is the historical spending pattern for clinical coordinating centers by NIH?

Historical spending patterns for clinical coordinating centers by the NIH reveal a consistent and significant investment in large-scale research networks. NIH frequently awards multi-year contracts and grants to establish and maintain these centers, which are crucial for managing complex, multi-site clinical trials. Funding levels can vary widely based on the disease area, the number of participating sites, and the duration of the research. Awards in the range of several million dollars per year for coordinating centers are not uncommon for major national or international research initiatives. The NIH's commitment to these centers underscores their importance in translating basic science discoveries into clinical practice and improving public health outcomes through evidence-based medicine.

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

Offers Received: 21

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Parent Company: Partners Healthcare System, Inc (UEI: 825636988)

Address: 55 FRUIT ST, BOSTON, MA, 02114

Business Categories: Category Business, Hospital, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $14,667,315

Exercised Options: $14,667,315

Current Obligation: $11,062,845

Timeline