NIH awards $10M+ for cancer chemopreventive agent trials, spanning over a decade

Contract Overview

Contract Amount: $10,040,482 ($10.0M)

Contractor: Northwestern University

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: $2.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 11

Pricing Type: COST NO FEE

Sector: R&D

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

Place of Performance

Location: CHICAGO, COOK County, ILLINOIS, 60611

State: Illinois Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.0 million to NORTHWESTERN UNIVERSITY for work described as: IGF::OT::IGF PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS Key points: 1. Contract awarded through full and open competition, suggesting a robust market. 2. Long contract duration of over 10 years indicates a sustained research effort. 3. Cost-plus-fee contract type may incentivize cost overruns if not managed closely. 4. Research and Development sector, focusing on life sciences, aligns with NIH mission. 5. Significant funding allocated to a single awardee, Northwestern University. 6. The contract's value is substantial, reflecting the complexity and scope of clinical trials.

Value Assessment

Rating: fair

The contract value of over $10 million for a decade-long research project is substantial. Benchmarking this against similar large-scale, multi-year clinical trial contracts for cancer research would be necessary for a precise value-for-money assessment. The 'Cost No Fee' (CNF) contract type, while unusual for R&D, suggests that the contractor is reimbursed for allowable costs but receives no fee. This can sometimes indicate a focus on cost control by the government, but it's important to understand the specific rationale for this contract type in this context.

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 proposals. The presence of 11 bids suggests a competitive environment for this research area. A high number of bidders generally allows for better price discovery and selection of the most capable offeror at a reasonable cost.

Taxpayer Impact: Taxpayers benefit from a competitive process that aims to secure the best value for public funds by encouraging multiple research institutions to propose their most effective approaches.

Public Impact

Patients with cancer or at high risk for cancer may benefit from the development of new chemopreventive agents. The research aims to deliver novel therapeutic strategies to combat cancer. The geographic impact is primarily within Illinois, where Northwestern University is located, but the research findings have national and global implications. The contract supports scientific research personnel, including scientists, clinicians, and support staff, contributing to the biomedical research workforce.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration could lead to scope creep or evolving research needs requiring careful management.
Cost-no-fee contract type needs careful monitoring to ensure efficient use of funds without compromising research quality.
Reliance on a single institution for such a long-term, critical research area might pose risks if institutional capacity or focus shifts.

Positive Signals

Awarded through full and open competition, indicating a broad search for the best research capabilities.
The substantial funding suggests a high level of confidence in the contractor's ability to conduct complex clinical trials.
The research focus on cancer chemoprevention directly addresses a major public health concern.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and medical research. The market for cancer research is substantial, with significant government and private investment. This award represents a portion of the National Institutes of Health's (NIH) broader portfolio aimed at advancing medical knowledge and improving public health outcomes. Comparable spending benchmarks would involve analyzing other large-scale clinical trial grants awarded by NIH and similar agencies.

Small Business Impact

There is no indication of small business set-asides for this contract, which is typical for large-scale, highly specialized research and development awards. Northwestern University, as the prime contractor, is a large research institution. Subcontracting opportunities for small businesses are not explicitly detailed but could potentially arise for specialized services or supplies required for the clinical trials.

Oversight & Accountability

Oversight is likely managed by the National Institutes of Health (NIH) program officials and contract officers. Accountability measures would include regular progress reports, milestone reviews, and adherence to clinical trial protocols and ethical guidelines. Transparency is generally maintained through public databases of federal contracts and NIH research publications, although specific details of ongoing trial methodologies may be proprietary.

Related Government Programs

National Cancer Institute (NCI) Research Grants
Clinical Trials Funding
Biomedical Research and Development
Cancer Prevention Research

Risk Flags

Long contract duration
Cost-no-fee contract type
Potential for scientific obsolescence over time

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.0 million to NORTHWESTERN UNIVERSITY. IGF::OT::IGF PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS

Who is the contractor on this award?

The obligated recipient is NORTHWESTERN UNIVERSITY.

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 $10.0 million.

What is the period of performance?

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

What is the specific focus of the cancer chemopreventive agents being studied under this contract?

The provided data does not specify the exact types of cancer chemopreventive agents. However, the contract's description, 'IGF::OT::IGF PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS,' suggests that the research involves testing agents in early-phase clinical trials (Phase 1 and Phase 2). These phases typically evaluate safety, dosage, and preliminary efficacy. Chemoprevention aims to use drugs or natural compounds to reduce the risk of developing cancer or to prevent its recurrence. The specific agents could range from existing drugs repurposed for prevention to novel compounds developed specifically for this purpose.

How does the 'Cost No Fee' (CNF) contract type typically function in a research context, and what are its implications?

A Cost No Fee (CNF) contract is a type of cost-reimbursement contract where the contractor is reimbursed for all allowable costs incurred in performing the contract, but receives no additional fee or profit. This is less common for research and development compared to other contract types like Cost Plus Fixed Fee (CPFF) or Fixed Price. In a research context, a CNF contract might be used when the government has a strong interest in the research outcome and wants to ensure the contractor is fully compensated for expenses, but the nature of the work is highly uncertain, making a fee difficult to negotiate or justify. It can incentivize the contractor to focus on completing the research efficiently to manage costs, as there is no profit margin. However, it also means the contractor has less financial incentive to innovate or go beyond the minimum requirements, as their profit is not tied to performance beyond cost recovery.

What is the typical duration and funding scale for Phase 1 and Phase 2 clinical trials, and how does this contract compare?

Phase 1 clinical trials are typically smaller, involving a few dozen healthy volunteers or patients, and focus on safety and dosage. They can last several months to a year. Phase 2 trials involve a larger group of patients (dozens to hundreds) and focus on preliminary efficacy and further evaluation of safety. These can last from several months to two years. A contract spanning over 10 years and valued at over $10 million suggests this is not a single trial but likely a program of work encompassing multiple Phase 1 and Phase 2 trials, potentially across different agents or cancer types, or involving long-term follow-up. This duration and funding are substantial, indicating a significant, long-term commitment to advancing cancer chemoprevention research.

What are the potential risks associated with a decade-long research contract awarded to a single institution?

A decade-long research contract awarded to a single institution, like Northwestern University in this case, carries several potential risks. Firstly, institutional priorities or leadership could shift over such a long period, potentially impacting the focus or resources dedicated to the project. Secondly, scientific landscapes evolve rapidly; the initial research plan might become outdated or less relevant as new discoveries emerge, requiring significant adaptation. Thirdly, there's a risk of 'institutional inertia,' where the established processes and personnel may become less agile in responding to new challenges or opportunities. Finally, if the institution faces unforeseen financial difficulties or changes in its operational capacity, it could jeopardize the continuity of the research. Robust oversight and flexible contract management are crucial to mitigate these risks.

How does the National Institutes of Health (NIH) typically manage oversight for large, multi-year research grants like this one?

The NIH employs a multi-faceted approach to oversee large, multi-year research grants. Program Directors at the relevant NIH institute (in this case, likely the National Cancer Institute) serve as the primary scientific and programmatic contacts. They review annual progress reports, monitor research milestones, and ensure compliance with grant terms and conditions. For contracts, Contract Officers and Technical Monitors play similar roles, ensuring adherence to the contract scope, budget, and performance metrics. Regular site visits, review meetings, and data audits are common mechanisms. The agency also relies on peer review processes for initial funding and often for continuation applications or major modifications. Transparency is fostered through public access to research findings via publications and databases, though specific contract details remain confidential.

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: 11

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 633 CLARK ST, EVANSTON, IL, 60208

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

Financial Breakdown

Contract Ceiling: $21,566,986

Exercised Options: $2,252,375

Current Obligation: $10,040,482

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline