NIH invests $14.8M in Mayo Clinic for cancer chemopreventive agent trials, spanning over a decade

Contract Overview

Contract Amount: $14,808,279 ($14.8M)

Contractor: Mayo Clinic

Awarding Agency: Department of Health and Human Services

Start Date: 2003-09-30

End Date: 2014-09-29

Contract Duration: 4,017 days

Daily Burn Rate: $3.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 11

Pricing Type: COST NO FEE

Sector: R&D

Official Description: PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS

Place of Performance

Location: ROCHESTER, OLMSTED County, MINNESOTA, 55905

State: Minnesota Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $14.8 million to MAYO CLINIC for work described as: PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS Key points: 1. Contract awarded through full and open competition, suggesting a robust selection process. 2. Long contract duration (over 10 years) indicates a sustained research effort. 3. Cost-plus-fixed-fee contract type allows for flexibility in research but requires careful cost monitoring. 4. Focus on cancer chemopreventive agents highlights a critical area of public health research. 5. The award to a single entity, Mayo Clinic, suggests specialized expertise was sought. 6. The contract's value, while significant, needs to be benchmarked against similar long-term R&D efforts.

Value Assessment

Rating: fair

The contract value of $14.8 million over more than 10 years for Phase 1 and 2 clinical trials represents a substantial investment in cancer research. Benchmarking this against similar multi-year, multi-phase clinical trial contracts is challenging without more specific data on trial scope and complexity. The 'Cost No Fee' (CNF) contract type implies that the contractor is reimbursed for allowable costs but does not receive a fee, which can be advantageous for the government in terms of overall cost if managed effectively. However, it necessitates rigorous oversight to ensure costs remain reasonable and aligned with research objectives.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'FULL AND OPEN COMPETITION,' indicating that all responsible sources were permitted to submit a bid. With 11 bids received, this suggests a healthy level of interest and competition for this research opportunity. A competitive process like this generally leads to better price discovery and potentially more innovative solutions as contractors vie for the award.

Taxpayer Impact: A competitive award process helps ensure that taxpayer dollars are used efficiently by driving down costs and encouraging high-quality research proposals.

Public Impact

The primary beneficiaries are patients and the public through advancements in cancer prevention strategies. The contract supports the delivery of critical Phase 1 and 2 clinical trial data for novel cancer chemopreventive agents. The geographic impact is primarily centered in Minnesota, where Mayo Clinic is located, but the research findings have national and global implications. The contract supports a highly skilled workforce in clinical research, oncology, and pharmaceutical development.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration could lead to scope creep or evolving research needs that may not be fully captured in the initial award.
Cost-plus-fixed-fee contracts, while allowing flexibility, require diligent oversight to prevent cost overruns and ensure value for money.
The specific outcomes and effectiveness of the chemopreventive agents are subject to the inherent risks of clinical research.

Positive Signals

Awarded through full and open competition with multiple bidders, indicating a strong selection process.
The focus on cancer chemoprevention addresses a significant public health need.
The contract is with a reputable research institution (Mayo Clinic), suggesting a high likelihood of quality execution.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and healthcare. The market for clinical trial services is substantial, driven by pharmaceutical and biotechnology companies, as well as government health agencies. This contract represents a government investment in early-stage drug development for cancer prevention, a critical area within the broader biomedical R&D landscape. Comparable spending benchmarks would involve looking at other NIH-funded clinical trial grants and contracts for similar phases and therapeutic areas.

Small Business Impact

There is no explicit indication of small business set-asides for this contract, and the prime contractor is Mayo Clinic, a large research institution. However, large research contracts often involve subcontracting opportunities for specialized services, which could potentially benefit small businesses in areas like data analysis, laboratory support, or specific research components. Further investigation into subcontracting plans would be needed to assess the full impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), a division of the Department of Health and Human Services. Mechanisms likely include regular progress reports, financial reviews, and potentially site visits to ensure adherence to research protocols and budget. The 'Cost No Fee' structure necessitates close monitoring of expenditures to ensure they are allowable and reasonable. Transparency is generally maintained through public reporting of research findings and contract award data.

Related Government Programs

National Institutes of Health Research Grants
Clinical Trials Funding
Cancer Research Programs
Biomedical R&D Contracts
Department of Health and Human Services Initiatives

Risk Flags

Long contract duration may require significant oversight to manage evolving research needs.
Cost-plus-fixed-fee contracts necessitate careful monitoring of expenditures.
Clinical trial outcomes inherently carry research risks.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $14.8 million to MAYO CLINIC. PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS

Who is the contractor on this award?

The obligated recipient is MAYO CLINIC.

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 $14.8 million.

What is the period of performance?

Start: 2003-09-30. End: 2014-09-29.

What is the specific scope and methodology of the Phase 1 and 2 clinical trials being conducted under this contract?

The contract, valued at approximately $14.8 million, supports Phase 1 and Phase 2 clinical trials for cancer chemopreventive agents. Phase 1 trials typically assess the safety, dosage, and side effects of a new agent in a small group of people. Phase 2 trials further evaluate the effectiveness of the agent and continue to monitor safety in a larger group of patients. While the specific agents and methodologies are not detailed in the provided data, the contract's duration (over 10 years) suggests a comprehensive and potentially multi-arm investigation into various chemopreventive strategies. The research is conducted by the Mayo Clinic, a leading medical research institution, under the auspices of the National Institutes of Health (NIH).

How does the $14.8 million contract value compare to other NIH-funded clinical trial contracts of similar scope and duration?

Benchmarking the $14.8 million contract value requires detailed comparison with other NIH-funded Phase 1 and 2 clinical trials. Factors influencing cost include the number of participants, the complexity of the trial protocols, the duration of patient follow-up, the specific therapeutic area, and the overhead costs associated with the research institution. Given this contract spans over a decade, the annual average expenditure is roughly $1.48 million. This figure needs to be contextualized against the typical costs for multi-year, multi-phase clinical trials, which can vary significantly. Without access to a database of comparable NIH contracts with detailed cost breakdowns, a precise comparison is difficult, but the investment appears substantial for a long-term research endeavor.

What are the potential risks associated with a Cost No Fee (CNF) contract for long-term clinical research?

A Cost No Fee (CNF) contract, while potentially cost-saving for the government as it eliminates contractor profit, carries specific risks in a long-term clinical research setting. The primary risk is that the contractor may have less incentive to control costs rigorously compared to a contract with a fee, as their reimbursement is tied directly to allowable expenses. This necessitates robust government oversight to scrutinize all expenditures and ensure they are necessary, reasonable, and allocable to the contract. Furthermore, if unforeseen challenges arise in the research that significantly increase costs, the lack of a fee might disincentivize the contractor from going above and beyond to resolve issues, potentially impacting research timelines or quality if not managed proactively.

What is the track record of Mayo Clinic in managing large-scale federal research contracts, particularly in oncology?

Mayo Clinic is a globally recognized academic medical center with a long and distinguished history of conducting cutting-edge medical research, including extensive work in oncology. They are a frequent recipient of federal research funding, particularly from agencies like the National Institutes of Health (NIH). Their track record in managing large-scale federal contracts is generally considered strong, characterized by significant contributions to medical knowledge and successful completion of complex research projects. Their expertise in clinical trials, patient care, and scientific innovation positions them well to handle substantial research investments. While specific performance metrics for all past contracts are not publicly detailed, their reputation and continued funding suggest a high level of competence and reliability in executing federally funded research.

How has NIH funding for cancer chemoprevention research evolved over the period of this contract (2003-2014)?

During the period of this contract (2003-2014), NIH funding for cancer chemoprevention research saw significant activity and evolution. The National Cancer Institute (NCI), part of NIH, has consistently prioritized research into preventing cancer, including the study of agents that can reduce cancer risk or recurrence. This era saw advancements in understanding molecular pathways involved in cancer development, leading to the identification of potential chemopreventive targets. Funding levels fluctuated based on federal budget appropriations and shifting research priorities, but there was a sustained commitment to exploring both natural compounds and synthetic agents. The contract's long duration reflects the time-intensive nature of clinical trials, from early-stage safety and efficacy testing through to more advanced studies.

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

Solicitation ID: NA

Offers Received: 11

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Parent Company: Mayo Foundation (UEI: 167141923)

Address: 200 1ST ST SW, ROCHESTER, MN, 55905

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

Financial Breakdown

Contract Ceiling: $45,275,397

Exercised Options: $14,273,119

Current Obligation: $14,808,279

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline