Leidos Biomedical Research Inc. awarded $72.4M for COVID-19 clinical trial management by NIH

Contract Overview

Contract Amount: $72,440,795 ($72.4M)

Contractor: Leidos Biomedical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2020-04-01

End Date: 2023-12-31

Contract Duration: 1,369 days

Daily Burn Rate: $52.9K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: INITIATE THE MANAGEMENT, OVERSIGHT, AND CONDUCT OF THE NIAID DMID CLINICAL TRIAL TITLED "A MULTICENTER, ADAPTIVE, RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19".

Place of Performance

Location: FREDERICK, FREDERICK County, MARYLAND, 21702

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $72.4 million to LEIDOS BIOMEDICAL RESEARCH INC for work described as: INITIATE THE MANAGEMENT, OVERSIGHT, AND CONDUCT OF THE NIAID DMID CLINICAL TRIAL TITLED "A MULTICENTER, ADAPTIVE, RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19". Key points: 1. Contract focuses on managing a critical clinical trial for COVID-19 therapeutics, indicating high national priority. 2. The fixed-fee structure for this cost-plus contract suggests a defined profit margin for the contractor. 3. A long contract duration of over three years points to the complexity and ongoing nature of the research. 4. The contract is for Research and Development in Life Sciences, a sector with significant federal investment. 5. The award was made under full and open competition, implying a broad search for qualified contractors. 6. The specific NAICS code (541715) highlights the specialized nature of the research and development services required.

Value Assessment

Rating: good

The contract value of $72.4 million over approximately three years for managing a complex, multi-center clinical trial appears reasonable given the scope. Benchmarking against similar large-scale clinical trial management contracts managed by federal agencies like NIH would provide a more precise value-for-money assessment. The cost-plus-fixed-fee structure allows for cost reimbursement with a predetermined profit, which can be efficient for research where costs are not fully predictable but requires careful oversight to prevent cost overruns.

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 bidders had the opportunity to submit proposals. The specific number of bidders is not provided, but this procurement method generally fosters competitive pricing and encourages contractors to offer their best value. The agency likely sought a contractor with demonstrated expertise in managing large-scale, complex clinical trials, particularly in the rapidly evolving field of infectious diseases.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it increases the likelihood of securing services at a competitive price, ensuring that federal funds are used efficiently for critical research.

Public Impact

The primary beneficiaries are patients participating in the COVID-19 clinical trial, who gain access to investigational therapeutics. The services delivered include the management, oversight, and conduct of a multi-center, adaptive, randomized controlled trial. The geographic impact is national, as the trial is multicenter, likely involving research sites across the United States. Workforce implications include employment for researchers, clinical coordinators, data managers, and administrative staff involved in the trial.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in a cost-plus contract if not rigorously managed.
Ensuring consistent data quality and integrity across multiple trial sites.
Adapting trial protocols quickly to evolving scientific understanding of COVID-19.
Maintaining patient safety and ethical standards throughout the trial.
Timely recruitment and retention of diverse patient populations.

Positive Signals

Contract awarded through full and open competition, suggesting a competitive process.
Focus on a critical public health issue (COVID-19 therapeutics) aligns with national priorities.
Experienced contractor (Leidos Biomedical Research Inc.) likely possesses relevant expertise.
Clear objectives for safety and efficacy of investigational therapeutics.
Adaptive trial design allows for flexibility and efficiency in research.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. The market for clinical trial management services is robust, with numerous contract research organizations (CROs) and research institutions competing for federal and private funding. Federal spending in this area is substantial, driven by public health emergencies and ongoing investments in medical innovation. Comparable spending benchmarks would involve analyzing other large-scale clinical trial management contracts awarded by agencies like NIH, CDC, and other health-focused federal bodies.

Small Business Impact

The contract data indicates that small business participation (ss and sb fields) is false, suggesting this is not a small business set-aside contract. There is no explicit information on subcontracting plans for small businesses. However, given the scale and specialized nature of managing a large clinical trial, it is possible that Leidos Biomedical Research Inc. may engage small businesses for specific support services, though this is not a primary focus of the contract's structure.

Oversight & Accountability

Oversight is likely conducted by the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID). Accountability measures would include adherence to the trial protocol, data reporting requirements, and financial accountability for the cost-plus-fixed-fee structure. Transparency is generally maintained through public reporting of trial results and contract awards, though specific internal oversight mechanisms are not detailed in the provided data.

Related Government Programs

NIH COVID-19 Research Funding
NIAID Clinical Trial Management Contracts
Federal Biomedical Research and Development
Public Health Emergency Response Contracts
National Clinical Trial Networks

Risk Flags

Cost Overrun Risk
Data Integrity and Quality
Patient Recruitment Challenges
Regulatory Compliance
Contractor Performance Monitoring

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $72.4 million to LEIDOS BIOMEDICAL RESEARCH INC. INITIATE THE MANAGEMENT, OVERSIGHT, AND CONDUCT OF THE NIAID DMID CLINICAL TRIAL TITLED "A MULTICENTER, ADAPTIVE, RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19".

Who is the contractor on this award?

The obligated recipient is LEIDOS BIOMEDICAL RESEARCH INC.

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 $72.4 million.

What is the period of performance?

Start: 2020-04-01. End: 2023-12-31.

What is the track record of Leidos Biomedical Research Inc. in managing large-scale clinical trials, particularly for infectious diseases?

Leidos Biomedical Research Inc. has a significant track record in managing complex biomedical research and development projects, often serving as a prime contractor for government agencies like the National Institutes of Health (NIH). They operate the Frederick National Laboratory for Cancer Research (FNLCR) and have extensive experience in areas including infectious diseases, cancer, and clinical trial operations. Their capabilities encompass study design, protocol development, site management, data collection and analysis, and regulatory compliance. While specific details on their COVID-19 trial management experience prior to this award would require deeper investigation, their established infrastructure and history with NIH suggest a strong foundation for undertaking such critical research.

How does the $72.4 million contract value compare to similar NIH-funded clinical trial management contracts?

The $72.4 million contract value for managing a multi-center, adaptive, randomized controlled trial for COVID-19 therapeutics over approximately three years appears to be within a reasonable range for large-scale federal clinical research initiatives. NIH frequently awards contracts in the tens to hundreds of millions of dollars for managing complex clinical trials, especially those addressing urgent public health needs. For instance, contracts for managing large HIV/AIDS clinical trials or other major vaccine efficacy studies can reach similar or higher figures. The specific cost-effectiveness would depend on the number of trial sites, patient enrollment targets, duration, and the complexity of the adaptive design, but the overall magnitude aligns with federal investments in critical medical research.

What are the primary risks associated with managing this specific COVID-19 clinical trial, and how are they being mitigated?

Key risks include the rapidly evolving scientific understanding of COVID-19, potential for new variants impacting therapeutic efficacy, challenges in patient recruitment and retention, ensuring consistent data quality across multiple sites, and managing the complexities of an adaptive trial design. Mitigation strategies likely involve close collaboration between Leidos, NIAID, and trial investigators; robust data monitoring committees; flexible protocol amendments based on emerging data; strong site engagement and patient outreach programs; and rigorous quality assurance processes. The cost-plus-fixed-fee structure also necessitates careful financial oversight to manage costs effectively.

How effective is the adaptive trial design in accelerating the development of safe and effective COVID-19 therapeutics?

Adaptive trial designs are generally considered more efficient than traditional fixed designs because they allow for pre-planned modifications based on accumulating data. This can include adjusting sample sizes, dropping ineffective treatment arms, or re-randomizing participants to more promising therapies. For COVID-19, where the pandemic evolved rapidly, adaptive designs are crucial for quickly identifying and advancing the most promising treatments while discontinuing those that are unlikely to succeed. This speeds up the process of bringing effective therapies to patients and conserves resources by avoiding the continuation of futile treatment arms, thereby enhancing the overall effectiveness and speed of therapeutic development.

What has been the historical spending pattern for clinical trial management services by NIAID or similar NIH divisions?

NIAID and other NIH divisions have consistently allocated substantial funding towards clinical trial management. Historical spending patterns show significant investments in large-scale, multi-site trials for infectious diseases, HIV/AIDS, influenza, and emerging threats. The annual outlays for such contracts can range from tens of millions to hundreds of millions of dollars, depending on the number and scale of ongoing trials. Spending often increases during public health emergencies, as seen with COVID-19, where rapid development and testing of countermeasures become a national priority, leading to accelerated contract awards and increased funding allocations for trial management.

What are the implications of the 'cost plus fixed fee' contract type for government oversight and contractor performance?

A Cost Plus Fixed Fee (CPFF) contract type means the contractor is reimbursed for allowable costs incurred, plus a predetermined fixed fee representing profit. This structure is often used when the exact costs are difficult to estimate beforehand, common in R&D. For government oversight, it requires diligent monitoring of costs to ensure they are allowable and reasonable, and that the contractor is adhering to the scope of work. Contractor performance is incentivized by the need to complete the project within budget to avoid eating into their fixed fee, but also by the potential for future contracts. However, it can also create less incentive for cost savings compared to fixed-price contracts, making robust oversight critical.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and 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

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: Leidos Holdings, Inc.

Address: 1050 BOYLES ST, FREDERICK, MD, 21702

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $72,440,795

Exercised Options: $72,440,795

Current Obligation: $72,440,795

Actual Outlays: $72,284,864

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $243,580

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: 75N91019D00024

IDV Type: IDC

Timeline