Wake Forest University Health Sciences awarded $31.2M for diabetes cardiovascular risk study coordination

Contract Overview

Contract Amount: $31,180,157 ($31.2M)

Contractor: Wake Forest University Health Sciences

Awarding Agency: Department of Health and Human Services

Start Date: 2011-02-14

End Date: 2016-12-31

Contract Duration: 2,147 days

Daily Burn Rate: $14.5K/day

Competition Type: NOT COMPETED

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: R&D

Official Description: ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) STUDY- COORDINATING CENTER

Place of Performance

Location: WINSTON SALEM, FORSYTH County, NORTH CAROLINA, 27157

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $31.2 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES for work described as: ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) STUDY- COORDINATING CENTER Key points: 1. Contract awarded for a follow-on study to coordinate research on cardiovascular risk in diabetes. 2. The contract value represents a significant investment in understanding and mitigating diabetes-related health risks. 3. Awarded as a definitive contract, indicating a long-term commitment to the research objectives. 4. The research falls under the 'Research and Development in the Physical, Engineering, and Life Sciences' NAICS code. 5. The contract duration spans over five years, suggesting a comprehensive research approach. 6. The 'Cost No Fee' contract type implies that the government reimburses allowable costs without an additional fee.

Value Assessment

Rating: fair

The contract value of $31.2 million over approximately five years for a coordinating center for a large-scale clinical study appears reasonable given the scope. However, without specific benchmarks for similar coordinating centers in multi-site clinical trials, a precise value-for-money assessment is challenging. The 'Cost No Fee' structure means the government bears the direct costs of the research, which can be efficient if costs are well-managed, but it removes the incentive for cost savings by the contractor.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, meaning it was not competed among multiple offerors. This typically occurs when a specific contractor possesses unique capabilities, intellectual property, or is essential for the continuation of an ongoing project. The lack of competition means that the government did not benefit from potential price reductions or innovative solutions that might have emerged from a competitive bidding process.

Taxpayer Impact: Sole-source awards can potentially lead to higher costs for taxpayers as there is no competitive pressure to drive down prices. It also limits opportunities for other qualified organizations to secure federal funding.

Public Impact

The primary beneficiaries are individuals with diabetes, who stand to gain from improved understanding and management of cardiovascular risks. The study aims to deliver critical data and insights that can inform clinical practice and public health guidelines. The geographic impact is likely national, given the nature of large-scale clinical research coordination. The contract supports a workforce of researchers, project managers, and administrative staff involved in coordinating the study.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source award limits competitive pricing and potential innovation.
Cost-reimbursable contract type requires diligent oversight to manage expenditures effectively.
Lack of competition may reduce transparency in cost justification.

Positive Signals

Supports critical research in a major public health area (diabetes and cardiovascular disease).
Long-term contract duration allows for sustained effort and completion of complex research objectives.
Awarded to an established institution (Wake Forest University Health Sciences) likely with relevant expertise.

Sector Analysis

This contract falls within the Health and Medical Research and Development sector, specifically focusing on clinical trials and epidemiological studies related to chronic diseases. The market for coordinating centers in large clinical trials is specialized, often involving academic medical centers and research organizations with proven track records in managing complex, multi-site studies. Spending in this area is driven by the need to address significant public health challenges like diabetes and its associated complications.

Small Business Impact

This contract does not appear to have a small business set-aside component, nor is there information suggesting significant subcontracting opportunities for small businesses. The nature of coordinating a large clinical research study typically involves specialized expertise and infrastructure that may not be readily available from small businesses. Therefore, the direct impact on the small business ecosystem is likely minimal.

Oversight & Accountability

Oversight for this 'Cost No Fee' contract would primarily come from the National Institutes of Health (NIH), the awarding agency. Mechanisms would include regular progress reports, financial reviews, and potentially site visits to ensure that funds are used appropriately and research objectives are being met. Transparency is facilitated through public research databases and publications stemming from the study, though the specific contract details and cost breakdowns might be less accessible due to the sole-source nature.

Related Government Programs

National Diabetes Statistics Report
Centers for Disease Control and Prevention (CDC) Diabetes Programs
National Institutes of Health (NIH) Clinical Center
American Diabetes Association Research Grants

Risk Flags

Sole-source award
Cost-reimbursement contract type requires strong oversight

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $31.2 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES. ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) STUDY- COORDINATING CENTER

Who is the contractor on this award?

The obligated recipient is WAKE FOREST UNIVERSITY HEALTH SCIENCES.

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 $31.2 million.

What is the period of performance?

Start: 2011-02-14. End: 2016-12-31.

What is the specific research focus of the ACCORDION study and why was a follow-on contract necessary?

The ACTION TO CONTROL CARDIOVASCULAR RISK IN DIABETES FOLLOW-ON (ACCORDION) study is a continuation or expansion of previous research aimed at understanding and mitigating cardiovascular risks in individuals with diabetes. Follow-on contracts are common in long-term research projects to ensure continuity of operations, data collection, and analysis. The necessity for a follow-on contract typically arises from the need to complete ongoing research phases, incorporate new findings, or adapt to evolving scientific questions within the study's scope. This specific contract likely supports the coordination center's role in managing the complex logistics, data management, and communication required for a multi-site clinical trial focused on this critical health issue.

How does the 'Cost No Fee' contract type function, and what are its implications for cost control?

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 profit or fee. This structure is often used for research and development or other projects where the scope of work is uncertain or difficult to define precisely at the outset, and where the primary goal is to achieve a specific outcome rather than to generate profit for the contractor. For cost control, the government relies heavily on robust auditing and monitoring of the contractor's expenditures to ensure that costs are reasonable, allocable, and allowable. While it removes the profit motive, it also places a significant burden on the government to meticulously track and verify all incurred costs.

What are the potential risks associated with a sole-source award for a research coordination center?

Sole-source awards, while sometimes necessary for continuity or unique expertise, carry inherent risks. Primarily, the lack of competition can lead to higher costs for the government, as there is no market pressure to drive down prices. It also limits the opportunity for other qualified entities to demonstrate their capabilities and potentially offer more innovative or cost-effective solutions. Furthermore, without competitive benchmarking, it can be more challenging for the government to assess the fairness and reasonableness of the proposed costs. There's also a potential risk of contractor complacency if they perceive less oversight due to the absence of competitive pressure.

What is the significance of the NAICS code 541712 for this contract?

The North American Industry Classification System (NAICS) code 541712, 'Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology),' indicates that the primary activity under this contract is scientific research and development. This code specifically covers establishments primarily engaged in conducting research and development in areas such as computer and electronic products, chemicals, pharmaceuticals, and aerospace, as well as fundamental research in the physical, engineering, and life sciences. For this contract, it signifies that the work performed by Wake Forest University Health Sciences involves scientific inquiry and experimentation aimed at advancing knowledge and developing new applications, specifically related to understanding and managing cardiovascular risks in diabetes.

How does the duration of the contract (over 5 years) impact the research and its outcomes?

A contract duration of over five years for a research coordination center is highly significant and generally positive for the study's potential outcomes. Large-scale clinical research, especially involving chronic diseases like diabetes and their long-term complications, requires substantial time for participant recruitment, data collection, follow-up, and analysis. A longer duration allows for the study to achieve statistical power, capture meaningful trends, and potentially observe the effects of interventions over extended periods. It also provides stability for the research team and infrastructure, fostering expertise and efficient operations. This extended timeline is crucial for generating robust, reliable, and clinically relevant findings that can inform medical practice and public health policy.

Industry Classification

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

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Offers Received: 1

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Parent Company: Wake Forest University

Address: MEDICAL CENTER BLVD, WINSTON SALEM, NC, 27157

Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business

Financial Breakdown

Contract Ceiling: $31,180,157

Exercised Options: $31,180,157

Current Obligation: $31,180,157

Subaward Activity

Number of Subawards: 482

Total Subaward Amount: $525,463,465

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline