Over $26.6M Awarded to Regents of the University of California for STI Clinical Trials

Contract Overview

Contract Amount: $26,615,702 ($26.6M)

Contractor: Regents of the University of California, SAN Francisco, the

Awarding Agency: Department of Health and Human Services

Start Date: 2004-09-29

End Date: 2019-02-28

Contract Duration: 5,265 days

Daily Burn Rate: $5.1K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 4

Pricing Type: COST NO FEE

Sector: R&D

Official Description: SEXUALLY TRANSMITTED INFECTIONS CLINICAL TRIALS GROUP

Place of Performance

Location: SAN FRANCISCO, SAN FRANCISCO County, CALIFORNIA, 94118

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $26.6 million to REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE for work described as: SEXUALLY TRANSMITTED INFECTIONS CLINICAL TRIALS GROUP Key points: 1. The contract value of $26.6M over its period of performance suggests a significant investment in research. 2. Full and open competition indicates a broad search for qualified contractors, potentially leading to better pricing. 3. The definitive contract type, while flexible, requires careful monitoring to ensure adherence to scope and budget. 4. The long duration of the contract (5265 days) points to a sustained effort in a complex research area. 5. The absence of small business set-asides or subcontracting requirements may limit opportunities for smaller entities. 6. The contract is positioned within the R&D sector, specifically focusing on life sciences research.

Value Assessment

Rating: good

The contract value of $26.6 million over approximately 14.5 years represents a substantial investment in clinical trials for sexually transmitted infections. Benchmarking this against similar large-scale, multi-year R&D contracts in the life sciences is challenging without more specific data on the scope and deliverables. However, the 'Cost No Fee' (CNF) contract type suggests that the government reimburses allowable costs, and the contractor does not receive a fee. This can be cost-effective for the government if the contractor is efficient and manages costs well, but it also places the cost risk on the government. The long duration implies a complex, multi-phase research effort.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit offers. The number of bids received is not specified, but this procurement method generally fosters a competitive environment, which can lead to more favorable pricing and innovative solutions for the government. The agency likely sought a contractor with specialized expertise in conducting clinical trials for sexually transmitted infections.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it maximizes the pool of potential offerors, increasing the likelihood of receiving competitive bids and ensuring that the government obtains the best value for its investment.

Public Impact

The primary beneficiaries are public health initiatives aimed at understanding and combating sexually transmitted infections. The services delivered include conducting clinical trials, which are crucial for developing new treatments and prevention strategies. The geographic impact is likely national, given the scope of NIH-funded research, with potential for global health implications. The contract supports a specialized workforce in clinical research, including scientists, clinicians, and research staff.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'Cost No Fee' contract type places the financial risk on the government, requiring robust cost oversight.
The long contract duration necessitates careful management to ensure continued alignment with evolving research priorities and scientific advancements.
Lack of specified small business participation may limit broader economic impact and opportunities for smaller research organizations.

Positive Signals

Awarded through full and open competition, suggesting a robust and fair selection process.
The significant funding indicates a high level of confidence in the contractor's capabilities for critical public health research.
The focus on STI clinical trials addresses a significant public health need.

Sector Analysis

This contract falls within the Research and Development (R&D) sector, specifically in the sub-sector of life sciences and biomedical research. The National Institutes of Health (NIH) is a major funder of such research, with significant annual outlays dedicated to understanding and treating diseases. Comparable spending benchmarks would involve looking at other large, multi-year clinical trial grants and contracts awarded by NIH and other federal health agencies for complex disease research, which often run into tens or hundreds of millions of dollars over extended periods.

Small Business Impact

The provided data indicates that this contract was not awarded as a small business set-aside, nor does it explicitly mention subcontracting goals for small businesses. This suggests that the primary contractor, the Regents of the University of California, is likely a large institution. Consequently, the direct impact on the small business ecosystem may be limited unless the prime contractor voluntarily engages small businesses as subcontractors. Further investigation into subcontracting plans would be needed to fully assess the impact on small businesses.

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 (HHS). As a 'Cost No Fee' definitive contract, oversight would focus on ensuring that all costs incurred are allowable, reasonable, and allocable to the contract's objectives. Regular reporting, site visits, and audits by NIH contracting officers and potentially the HHS Office of Inspector General (OIG) would be expected to ensure accountability and transparency throughout the contract's long duration.

Related Government Programs

National Institutes of Health Research Grants
Centers for Disease Control and Prevention (CDC) Public Health Programs
Biomedical Research and Development
Clinical Trial Management
Infectious Disease Research

Risk Flags

Long contract duration may increase risk of scope drift or obsolescence.
Cost-reimbursement nature requires diligent cost monitoring.
Lack of specified small business participation.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $26.6 million to REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE. SEXUALLY TRANSMITTED INFECTIONS CLINICAL TRIALS GROUP

Who is the contractor on this award?

The obligated recipient is REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE.

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 $26.6 million.

What is the period of performance?

Start: 2004-09-29. End: 2019-02-28.

What is the track record of the Regents of the University of California in managing large federal research contracts, particularly in clinical trials?

The Regents of the University of California, specifically through institutions like the University of California, San Francisco (UCSF), have a well-established and extensive track record in managing large-scale federal research grants and contracts, including complex clinical trials. UCSF is consistently ranked among the top institutions for NIH funding and has a long history of conducting pivotal research across various medical disciplines. Their experience encompasses navigating regulatory requirements, managing multi-site studies, ensuring data integrity, and adhering to ethical standards in human subject research. While specific details on past STI clinical trial contracts would require deeper analysis, UCSF's overall profile suggests a high level of competence and experience in handling contracts of this nature and magnitude.

How does the $26.6 million contract value compare to other federal investments in sexually transmitted infection (STI) research?

The $26.6 million awarded over approximately 14.5 years represents a significant, but not unprecedented, investment in STI research by the federal government. The National Institutes of Health (NIH), which awarded this contract, allocates billions annually to biomedical research, with a substantial portion dedicated to infectious diseases, including STIs. Large, multi-year clinical trial contracts and grants are common for complex research endeavors. To provide a precise comparison, one would need to analyze NIH's historical funding patterns for STI research, looking at the average award size, duration, and number of active projects. However, this contract's value suggests a commitment to a substantial, long-term research effort addressing critical public health needs related to STIs.

What are the primary risks associated with a 'Cost No Fee' (CNF) contract of this duration for clinical trials?

A 'Cost No Fee' (CNF) contract, especially one spanning over 14 years for clinical trials, presents several key risks. Primarily, the financial risk is borne by the government, as it reimburses the contractor for all allowable costs without an additional fee. This necessitates rigorous oversight to ensure costs are reasonable, allocable, and necessary. Scope creep is another significant risk; the long duration increases the potential for research objectives to evolve, requiring careful contract modifications to manage budget implications. Furthermore, contractor performance risk exists – if the contractor is inefficient or encounters unforeseen scientific or logistical challenges, the government may incur higher-than-expected costs without a corresponding increase in profit for the contractor, potentially impacting motivation or leading to resource constraints. Ensuring continued scientific relevance and adherence to evolving ethical and regulatory standards over such a long period also poses a challenge.

What is the potential impact of this contract on the development of new STI treatments or prevention methods?

This contract has the potential for a substantial positive impact on the development of new STI treatments and prevention methods. By funding extensive clinical trials, it directly supports the rigorous testing required to bring novel therapies, vaccines, or diagnostic tools from the laboratory to public use. Successful completion of these trials could lead to breakthroughs in managing or eradicating specific STIs, improving patient outcomes, reducing transmission rates, and alleviating the significant public health burden associated with these infections. The long-term nature of the funding allows for in-depth investigation and follow-up, which is crucial for understanding efficacy, safety, and long-term effects of potential interventions.

How does the 'full and open competition' procurement method influence the value and quality of services obtained for STI research?

The 'full and open competition' procurement method is designed to maximize value and quality by allowing any responsible source to submit an offer. This broadens the potential applicant pool, increasing the likelihood that the most qualified and cost-effective research institution will be selected. By fostering competition, it encourages offerors to propose innovative approaches and competitive pricing. For STI research, this means the government can potentially access cutting-edge scientific expertise and efficient trial management practices at a better price point than through more restrictive methods. The transparency inherent in full and open competition also enhances accountability and public trust in the research funding process.

What are the implications of the contract being awarded to a university research group (Regents of the University of California) versus a private pharmaceutical company?

Awarding this contract to a university research group like the Regents of the University of California typically implies a focus on fundamental research, public health objectives, and potentially less emphasis on immediate commercialization compared to a private pharmaceutical company. Universities often excel in early-stage research, complex trial design, and addressing less commercially lucrative but critical public health needs. While they may partner with industry, their primary driver is often scientific advancement and public benefit. Private companies, conversely, might be more geared towards developing products with clear market potential and profitability, potentially leading to faster translation but possibly prioritizing certain diseases over others. Both models have strengths, but for a broad clinical trial initiative driven by public health needs, a university's expertise is often highly valuable.

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

Offers Received: 4

Pricing Type: COST NO FEE (S)

Contractor Details

Parent Company: State of California Controllers Office

Address: 1855 FOLSOM ST STE 425, SAN FRANCISCO, CA, 94103

Business Categories: Category Business, Educational Institution, Government, Higher Education, Nonprofit Organization, Not Designated a Small Business, U.S. Regional/State Government

Financial Breakdown

Contract Ceiling: $46,494,680

Exercised Options: $30,582,025

Current Obligation: $26,615,702

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Timeline