National Institute on Aging: Leading Project Management Practices Are Important for Large-Scale Health Data Efforts
Fast Facts
The National Institute on Aging's Real-World Data Platform aimed to improve research into Alzheimer's disease by compiling and analyzing real-world data. This data could come from people's health records, apps and sensors, pharmacy claims, and more.
We found that NIA hadn't fully implemented leading project management or cost estimating practices for the platform. For example, NIA's cost estimate was anticipated at $312 million over 6 years, but its documentation didn't include all costs. Due in part to our work, Congress urged NIA to pause the funding.
In April 2024, NIA decided not to fund the project, so we didn't make any recommendations.
Highlights
What GAO Found
The National Institute on Aging's (NIA) Real-World Data Platform was to improve research into Alzheimer's disease and related dementias by compiling and analyzing real-world data. However, during the course of GAO's work in April 2024, NIA decided not to fund the data platform. Prior to NIA's decision not to fund the platform, the institute had not fully implemented key leading practices for the Real-World Data Platform's cost estimate or project management (see table).
Extent to Which NIA Implemented Key Leading Practices for the Real-World Data Platform’s Cost Estimate and Project Management
| Key Leading Practices | Assessment |
|---|---|
| Characteristics of a reliable cost estimate (comprehensive, well-documented, accurate, and credible) |
◔ Minimally implemented |
| Project management practice areas (governance, planning, requirements development and management, and risk management) |
◔ Minimally implemented |
Source: GAO analysis of National Institute on Aging (NIA) information. | GAO-24-106886
NIA's cost estimate for the Real-World Data Platform, which was anticipated at $312 million over 6 years, minimally met the four characteristics of a reliable cost estimate: comprehensive, well-documented, accurate, and credible. For example, while some cost estimate documentation for the project was updated during development, the documentation did not include all costs, describe how the current estimate was developed, or provide sufficient information about the source data used.
Further, NIA did not fully implement leading project management practices for the Real-World Data Platform. For example, while NIA described high-level milestones and risks for the project and created a federal staffing plan, it did not establish a governance structure for achieving the Real-World Data Platform's objectives and providing oversight for its planned development. Moreover, NIA did not develop a plan that included a detailed schedule, budget, and stakeholders needed for the project; record detailed requirements for the development of the core components; or create a risk management plan. NIA officials stated that the agency was not required to implement leading practices for cost estimating and project management, since the project was to be funded through a cooperative agreement with an awardee and these would have been the awardee's responsibilities.
In addition to Congress' concerns related to GAO's findings on cost estimating and project management, NIA officials stated that the decision not to fund the data platform was, in part, due to the presence of other federal large-scale health data efforts. They also cited an increased number of proposed solutions in the field of Alzheimer's disease and related dementias research. NIA officials stated there were lessons learned, which included the need for staff with a broad range of expertise, open collaboration with federal and non-federal partners, and other key considerations, such as data ownership and costs, when funding health data projects with the size and scope of the Real-World Data Platform.
Because NIA made the decision not to fund the Real-World Data Platform, GAO is making no recommendations. Nonetheless, GAO's analyses demonstrate the importance of developing reliable cost estimates and implementing effective project management practices.
In commenting on a draft of our report, the Department of Health and Human Services (HHS) noted its concerns with the criteria we used in our analysis and the potential impact of these criteria on other HHS annual awards. We continue to believe that we appropriately applied the criteria used to review NIA's efforts to develop the data platform and that our findings were limited in scope to that project. The department also provided technical comments which we incorporated as appropriate.
Why GAO Did This Study
NIA leads the federal government in conducting and supporting research on aging and the health and well-being of the older population under the leadership of the National Institutes of Health (NIH). This includes research on Alzheimer's disease, which is the seventh leading cause of death in the United States. To enhance research on Alzheimer's disease and related dementias, in March 2023, NIA proposed a multiyear project called the Real-World Data Platform, a large-scale health research project that would compile and analyze real-world Alzheimer's data using emerging technologies such as machine learning and artificial intelligence. However, in April 2024, NIA decided not to fund the project.
GAO was asked to review NIA's management of the data platform. This report (1) examines the extent to which NIA implemented leading practices for the cost estimate and project management for the Real-World Data Platform, and (2) describes NIA's decision not to fund the Real-World Data Platform and lessons learned. GAO analyzed NIA documentation, including plans and lessons learned; leading practices for cost estimating and project management; NIH policies and procedures; and requirements governing grants and cooperative agreements. GAO also interviewed NIA and NIH officials responsible for the project.
For more information, contact David B. Hinchman at (214) 777-5719 or hinchmand@gao.gov.