Over $10.8M awarded to UT MD Anderson for clinical trials of chemopreventive agents over 11 years

Contract Overview

Contract Amount: $10,891,426 ($10.9M)

Contractor: THE Univeristy of Texas M.D. Anderson Cancer Center

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: $2.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 11

Pricing Type: COST NO FEE

Sector: R&D

Official Description: PHASE I AND II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS

Place of Performance

Location: HOUSTON, HARRIS County, TEXAS, 77230

State: Texas Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.9 million to THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER for work described as: PHASE I AND II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS Key points: 1. Contract awarded for extensive research and development in life sciences. 2. Long duration suggests a complex, multi-phase research project. 3. High value indicates significant investment in cancer prevention research. 4. Focus on clinical trials points to a direct pathway to potential treatments. 5. The awardee is a major research institution, suggesting strong technical capabilities. 6. The contract spans over a decade, indicating a long-term commitment to the research area.

Value Assessment

Rating: good

The contract value of over $10.8 million for an 11-year period for clinical trials of chemopreventive agents appears reasonable given the scope and duration. Benchmarking against similar long-term R&D contracts for clinical trials is challenging due to the specialized nature of the research. However, the cost-no-fee contract type suggests that the government is primarily reimbursing direct costs, which can be an efficient model for research where outcomes are uncertain. The extensive duration implies a comprehensive 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 multiple potential offerors had the opportunity to bid. The presence of 11 bids suggests a competitive environment for this research area. A competitive process is generally expected to yield fair pricing and encourage innovation, although the specific nature of highly specialized R&D can sometimes limit the pool of qualified bidders.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it promotes a wider range of solutions and potentially drives down costs through market forces, ensuring federal funds are used efficiently for critical research.

Public Impact

Patients potentially benefiting from new chemopreventive agents developed through this research. Advancement of scientific knowledge in cancer prevention and treatment. The research is conducted in Texas, potentially impacting the local research workforce and economy. The development of new therapies could lead to improved public health outcomes in cancer prevention.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration could lead to scope creep or changes in research priorities over time.
The success of clinical trials is inherently uncertain, posing a risk to the investment.
Reliance on a single institution for such a long-term, critical research project.

Positive Signals

Award to a reputable research institution (UT MD Anderson) suggests a high likelihood of scientific rigor.
The 'cost no fee' contract type aligns costs with actual expenses, promoting efficiency.
Full and open competition indicates a robust selection process and potential for innovation.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and clinical trials for chemopreventive agents. The market for such specialized research is driven by government funding, pharmaceutical companies, and academic institutions. The significant investment reflects the ongoing national priority placed on cancer research and the development of novel therapeutic strategies. Comparable spending benchmarks would typically involve other large-scale, multi-year clinical research grants or contracts awarded by agencies like NIH.

Small Business Impact

There is no indication that this contract involved small business set-asides. Given the specialized nature of Phase I and II clinical trials and the award to a major research institution, it is unlikely that small businesses were primary awardees. Subcontracting opportunities for small businesses might exist for specific services or supplies, but the primary focus is on the core research conducted by the prime contractor.

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, scientific reviews, and financial audits to ensure the research is conducted according to protocol and within budget. The 'cost no fee' structure necessitates close monitoring of expenditures. Transparency is generally maintained through public reporting of research findings and adherence to federal research ethics guidelines.

Related Government Programs

National Cancer Institute Funding
Clinical Trials Research Grants
Biomedical Research and Development
Health and Human Services Research Contracts
Cancer Prevention Initiatives

Risk Flags

Long contract duration
Uncertainty of clinical trial outcomes
Reliance on a single institution for critical research

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.9 million to THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER. PHASE I AND II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS

Who is the contractor on this award?

The obligated recipient is THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER.

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 $10.9 million.

What is the period of performance?

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

What is the specific focus of the chemopreventive agents being studied in these clinical trials?

The provided data does not specify the exact types or targets of the chemopreventive agents. However, 'chemoprevention' generally refers to the use of drugs or natural compounds to block the development of cancer or stop it from progressing. Phase I and II clinical trials are early-stage studies. Phase I typically assesses safety, dosage, and side effects in a small group of people. Phase II further evaluates the effectiveness and continues to monitor safety in a larger group. The research likely aims to identify agents that can reduce the risk of developing specific types of cancer or prevent recurrence.

How does the $10.8 million cost compare to other similar long-term clinical trial contracts?

Directly comparing the $10.8 million cost to other similar long-term clinical trial contracts is complex without more specific details on the therapeutic area, trial phases, and duration. However, for multi-year, multi-phase clinical trials conducted by major research institutions, this figure represents a substantial but not necessarily outlier investment. The 'cost no fee' structure means the government reimburses actual allowable costs incurred by the contractor, plus a negotiated fee (which is zero in this case). This structure is common in research where outcomes are uncertain, aiming to cover direct research expenses efficiently. Benchmarking would require analyzing contracts with similar scientific objectives and institutional capacities.

What are the key performance indicators (KPIs) used to measure the success of this contract?

While specific KPIs are not detailed in the provided data, for Phase I and II clinical trials, success is typically measured by a combination of scientific and administrative metrics. Scientifically, key indicators would include the safety profile of the agents, the determination of optimal dosages, and evidence of efficacy (e.g., reduction in pre-cancerous lesions, biomarkers indicating reduced cancer risk). Administratively, success would involve adherence to research protocols, timely data collection and analysis, meeting enrollment targets for participants, and compliance with regulatory requirements. Regular progress reports submitted to NIH would outline these metrics.

What is the track record of The University of Texas M.D. Anderson Cancer Center in managing large federal research grants?

The University of Texas M.D. Anderson Cancer Center is a globally recognized leader in cancer research, treatment, and education. It consistently ranks among the top cancer centers in the United States and has a long and extensive history of successfully managing large-scale federal research grants, particularly from agencies like the National Institutes of Health (NIH) and the National Cancer Institute (NCI). Their track record includes numerous multi-year, multi-million dollar awards for complex clinical trials and basic science research, demonstrating a strong capacity for scientific leadership, project management, and fiscal responsibility in handling federal funding.

What are the potential risks associated with a 'cost no fee' contract for clinical trials?

A 'cost no fee' contract means the contractor is reimbursed for allowable costs but receives no additional profit or fee. For clinical trials, a primary risk is that the contractor might be less motivated to control costs aggressively if they are simply reimbursed for expenses, although scientific integrity and institutional reputation are strong motivators. Another risk is that the contractor might not invest in innovative approaches if they are not compensated for the associated risks. However, for research where the primary goal is scientific discovery and the outcome is uncertain, this contract type can be appropriate as it aligns reimbursement with actual research activities and avoids paying a fee on potentially unsuccessful research.

How has federal spending on cancer prevention research evolved over the duration of this contract (2003-2014)?

Federal spending on cancer prevention research, particularly through the NIH and NCI, has generally seen fluctuations but maintained a significant level of investment throughout the 2003-2014 period. This era saw increased focus on personalized medicine, genomics, and targeted therapies, alongside continued investment in traditional chemoprevention strategies. While specific annual appropriations vary based on congressional budgets and administration priorities, the overall commitment to cancer research remained a high priority. This contract's funding aligns with that sustained federal emphasis on advancing cancer prevention and treatment through scientific inquiry.

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: 11

Pricing Type: COST NO FEE (S)

Contractor Details

Parent Company: University of Texas System (UEI: 042000273)

Address: 1515 HOLCOMBE BLVD, HOUSTON, TX, 77030

Business Categories: Category Business, Educational Institution, Higher Education, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $4,298,131

Exercised Options: $4,298,131

Current Obligation: $10,891,426

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline