Biomedical clinical trial for systolic blood pressure study awarded to Wake Forest University for over $40.6 million

Contract Overview

Contract Amount: $40,698,794 ($40.7M)

Contractor: Wake Forest University Health Sciences

Awarding Agency: Department of Health and Human Services

Start Date: 2009-09-14

End Date: 2019-03-21

Contract Duration: 3,475 days

Daily Burn Rate: $11.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 7

Pricing Type: COST NO FEE

Sector: R&D

Official Description: BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE

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 $40.7 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES for work described as: BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE Key points: 1. The contract represents a significant investment in understanding and treating systolic blood pressure, a critical public health concern. 2. Awarded through full and open competition, suggesting a robust vetting process for potential contractors. 3. The long duration of the contract (over 9 years) indicates a complex, multi-phase research project. 4. The 'Cost No Fee' contract type suggests that the government reimburses allowable costs but does not pay a fixed fee, common in research settings. 5. The North Carolina location of the awardee may have implications for regional economic impact and workforce development. 6. The specific NAICS code (541712) points to a focus on Research and Development in the Physical, Engineering, and Life Sciences, excluding biotechnology.

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging without specific details on the scope of work and deliverables. However, the 'Cost No Fee' structure is typical for research grants where the exact costs are difficult to predict upfront. The total award amount of over $40 million over nearly a decade suggests a substantial research undertaking. Comparisons to similar large-scale biomedical clinical trials would be necessary for a more precise value assessment.

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. The presence of 7 bidders suggests a competitive environment for this research opportunity. This level of competition is generally favorable for price discovery and ensuring the government receives competitive proposals.

Taxpayer Impact: A competitive award process helps ensure that taxpayer funds are used efficiently by driving down costs and encouraging innovative approaches from multiple research institutions.

Public Impact

The primary beneficiaries are patients who may benefit from improved understanding and treatment of systolic blood pressure. The services delivered include conducting a complex biomedical clinical trial, generating valuable research data. The geographic impact is primarily centered in North Carolina, where Wake Forest University Health Sciences is located, potentially boosting local research infrastructure and expertise. Workforce implications include employment for researchers, clinicians, and support staff involved in the trial.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in long-term research projects where expenses are reimbursed.
The 'Cost No Fee' structure might offer less incentive for extreme cost efficiency compared to fixed-price contracts.
Ensuring the scientific rigor and ethical conduct of a multi-year clinical trial requires continuous oversight.

Positive Signals

Awarded through full and open competition, indicating a fair and transparent selection process.
The long-term nature of the contract suggests a commitment to a significant research endeavor with potentially high impact.
The selection of a reputable academic health sciences institution like Wake Forest University implies a focus on quality research.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and health. The market for biomedical research is substantial, driven by government funding agencies like NIH and private pharmaceutical investment. Contracts of this magnitude are typical for large-scale clinical trials investigating critical health issues. Benchmarks for similar NIH-funded clinical trials would provide further context on the scale and investment in this area.

Small Business Impact

There is no indication that this contract involved small business set-asides. Given the nature of large-scale biomedical research, prime contracting is typically awarded to established research institutions. Subcontracting opportunities for small businesses might exist for specialized services or equipment, but this is not explicitly detailed in the provided data.

Oversight & Accountability

Oversight for this contract would likely be managed by the National Institutes of Health (NIH), a division of HHS. Mechanisms would include regular progress reports, financial reviews, and potentially site visits to ensure adherence to research protocols and ethical standards. Transparency is generally maintained through public research databases and publications stemming from the trial's findings.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Clinical Trials.gov Registrations
Biomedical Research Funding
Cardiovascular Disease Research

Risk Flags

Long contract duration increases risk of cost escalation and changing research landscapes.
Cost-reimbursable contract type may offer less incentive for strict cost control compared to fixed-price.
Complexity of multi-year clinical trials requires significant oversight to ensure scientific integrity and data quality.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $40.7 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES. BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE

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 $40.7 million.

What is the period of performance?

Start: 2009-09-14. End: 2019-03-21.

What is the specific scientific objective of this biomedical clinical trial?

The provided data indicates the contract is for a 'BIOMEDICAL CLINICAL TRIAL TO STUDY SYSTOLIC BLOOD PRESSURE.' While the exact hypothesis or primary research question is not detailed, the objective is to investigate aspects of systolic blood pressure. This could range from understanding its underlying mechanisms, testing new therapeutic interventions, evaluating diagnostic methods, or assessing risk factors associated with elevated systolic blood pressure. Further details would typically be found in the contract's statement of work or associated research protocols, which are not included in this summary data.

How does the $40.6 million award compare to other NIH-funded clinical trials?

The $40.6 million award over approximately 9.5 years (from September 2009 to March 2019) averages to roughly $4.27 million per year. This figure is substantial but falls within the range of large, multi-center clinical trials funded by the National Institutes of Health (NIH). The NIH funds a wide spectrum of research, from small pilot studies to massive epidemiological investigations and extensive clinical trials. The specific cost per year for this trial is comparable to other Phase III or IV clinical trials investigating chronic conditions like hypertension, which often require long-term patient follow-up and extensive data collection.

What are the key performance indicators (KPIs) expected for this contract?

Key performance indicators for a biomedical clinical trial of this nature typically revolve around the successful execution of the research protocol and the generation of valid, reliable data. These would likely include metrics such as patient recruitment rates, patient retention throughout the study duration, adherence to the treatment or intervention plan, data completeness and accuracy, and timely reporting of interim and final results. Compliance with ethical guidelines and regulatory requirements (e.g., FDA regulations) would also be critical performance aspects. The 'Cost No Fee' contract type implies that performance is measured against the approved research plan rather than strict cost targets, though efficient use of resources is always expected.

What is Wake Forest University Health Sciences' track record with similar federal contracts?

Wake Forest University Health Sciences is a well-established academic medical center with a significant history of receiving federal funding, particularly from agencies like the NIH. They are known for their research capabilities across various medical disciplines. While specific details on all their past contracts are not provided here, their status as a major research institution suggests a strong track record in managing complex, large-scale research projects, including clinical trials. Their ability to secure a 'full and open competition' award of this magnitude further indicates a demonstrated capacity and competitiveness in the federal research contracting landscape.

What are the potential risks associated with a 'Cost No Fee' contract for a long-term clinical trial?

The primary risk associated with a 'Cost No Fee' contract, especially for a long-term project like a clinical trial, is the potential for cost overruns without a fixed profit incentive for the contractor to control expenses. While the government reimburses allowable costs, the total expenditure can exceed initial estimates if the research proves more complex or resource-intensive than anticipated. Another risk is that the lack of a direct fee tied to performance might reduce the contractor's motivation to achieve peak efficiency, although scientific integrity and successful outcomes remain paramount. Robust oversight and clear definition of allowable costs are crucial to mitigate these risks.

How does the duration of the contract (3475 days) impact the overall value and risk?

The contract duration of 3475 days, approximately 9.5 years, signifies a long-term, complex research endeavor. This extended timeline allows for in-depth study, potentially including multiple phases, long-term follow-up of participants, and comprehensive data analysis. From a value perspective, it suggests a significant investment aimed at generating substantial scientific knowledge. However, the extended duration also increases inherent risks, such as changes in research priorities, potential for participant attrition, evolving scientific understanding that might necessitate protocol adjustments, and the cumulative risk of cost escalation over time. Effective project management and adaptive planning are critical for mitigating these risks over such a long period.

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: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 7

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: $43,426,290

Exercised Options: $40,698,794

Current Obligation: $40,698,794

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Timeline