PCORnet-Designated Flu Dosing Study Pilots SMART IRB Approach

Flu season is upon us, and the The National Institute of Health (NIH)-funded INVESTED study is examining adults with heart disease who get infected with influenza, more commonly known as “the flu,” who are more likely to be at risk for heart attacks and hospitalization due to heart failure. Conducted through the National Patient-Centered Clinical Research Network (PCORnet), a PCORI initiative, the INVESTED study is making promising strides to reduce the risk of major cardiac-related events in these patients by determining what level of dosing is more effective in lowering cardiovascular or lung-related admissions to the hospital.

Although a standard yearly vaccination for influenza has been shown to reduce the risk of major cardiac-related events, preliminary data suggests that a high-dose vaccine can prove even more effective than a standard dose in decreasing the likelihood of influenza infection for individuals with heart disease. The INVESTED study team hopes to glean valuable insights that will ultimately reduce hospitalizations—and in some cases, death—of heart disease patients who contract the flu.

Piloting a Cost-efficient Approach to Research Study Reviews

In addition to its commitment to helping at-risk patients with heart disease, INVESTED is also piloting the use of a PCORnet-wide single Institutional Review Board (IRB) approach to significantly reduce the time and expense of conducting multisite collaborative clinical research studies within the network. This effort will enable PCORnet institutions to use the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform from the National Institutes of Health instead of the traditional approach of using local IRBs for each research site.

IRBs are in place to protect the rights and welfare of humans participating as subjects in research. The goal of SMART IRB is to streamline the IRB review process in multisite research, helping investigators obtain trial results faster and, ultimately, advance the development of new diagnostics, treatments, and preventative measures for patients, while maintaining strong human research protections, oversight, and regulatory compliance.

The SMART IRB maintains these ethical considerations with the use of a flexible master IRB reliance agreement that aims to simplify multisite research, as well as to support and encourage collaboration and harmonization across clinical studies. Although the NIH has mandated that all NIH-funded trials transition to SMART IRB by September 2017, PCORnet is already ahead of the game with its dedication to transitioning all its studies to this approach by the end of January 2017.

INVESTED ended its initial year in December, and data from this period are currently being analyzed to determine what benefits the SMART IRB approach brings to its multisite clinical research studies. Although more data is to come, INVESTED’s initial data analysis shows improvements in efficiencies in terms of study startup—small but significant developments that speak to the importance of this approach.

The INVESTED study is currently enrolling PCORnet sites to participate in the second year of the project.


About PCORnet

 PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.