STAR Clinical Research Network to Receive Major Grant Renewal

The STAR Clinical Research Network, based at Vanderbilt University Medical Center, has been approved for an additional $8.9 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) to support its efforts to improve health care throughout the Southeast and across the United States.

The funding will be provided over three years as part of PCORI’s support for the third phase of PCORnet, the National Patient-Centered Clinical Research Network.

Russell Rothman, MD, MPP, is principal investigator of the Stakeholders, Technology and Research Clinical Research Network (STAR CRN), which harnesses the power of electronic medical records to support comparative effectiveness research, pragmatic clinical trials and other research that is national in scope.

“We are excited to have three additional years of infrastructure funding from PCORI to expand the STAR CRN’s efforts to support a wide array of patient-centered research,” said Rothman, the Ingram Professor of Integrative and Population Health and professor of Internal Medicine, Pediatrics and Health Policy at VUMC.

STAR CRN has been the leading recruiter for three national studies, including the ADAPTABLE study, a pragmatic trial conducted through PCORnet to determine the optimal dose of aspirin to prevent heart attacks, strokes and death in patients with cardiovascular disease.

It also is a leader of the Accelerating COVID-19 Therapeutic Interventions and Vaccines, ACTIV-6, initiative, funded by the National Institutes of Health (NIH), which is testing the role of “repurposed” drugs to treat COVID-19.

Rothman, who directs the Institute for Medicine and Public Health at VUMC and who is VUMC’s Senior Vice president of Population and Public Health, has led the CRN since it was initially funded under a $6.9-million, 18-month contract with PCORI in 2014 as part of phase 1 of PCORnet.

STAR CRN includes the Vanderbilt Health System and Vanderbilt Health Affiliated Network, Meharry Medical College, University of North Carolina Health Care System, Duke Health Care System, Health Sciences of South Carolina, Wake Forest Baptist Health, Mayo Clinic, scores of hospitals, hundreds of medical practices and nearly 15 million diverse patients.

The new round of funding approved by the PCORI Board of Governors last week to support the activities of STAR and seven other CRNs around the country is part of PCORI’s support of phase 3 of PCORnet.

A “network of networks” funded by PCORI, PCORnet involves many major health systems across the nation, and provides access to health data, research expertise and patient insights to foster more efficient patient-centered clinical research.

PCORI is an independent, nonprofit organization authorized by Congress in 2010 to support research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed health care decisions.

“PCORnet has been critical to supporting COVID-19 research funded by the National Institutes of Health and surveillance funded by the Centers for Disease Control and Prevention,” PCORI announced.

The funding will help CRNs increase the diversity of their patient populations and settings, strengthen patient and stakeholder engagement, and provide high-quality data to power studies.

Through its electronic health record data, which can be linked to Medicare, Medicaid, state health data and commercial claims, STAR CRN can perform real-world evidence research on existing data.

It also can identify patients for study recruitment, leverage informatics tools for the electronic identification, contact, consent and recruitment of patients into studies, and collect patient-reported outcomes over time.

Robust stakeholder engagement is a key feature of STAR CRN and includes stakeholder advisory board reviews of research studies, identification of key stakeholders for projects and the use of Community Engagement Studies for stakeholder input.

Operating as a distributed data network, STAR CRN maintains eight distinct “data marts,” representing more than 370 million clinical encounters. Network members have deep expertise in data extraction and curation, natural language processing, machine learning and other approaches that help drive quality and innovation.

The team at VUMC developed and leverage REDCap, a secure web application for building and managing online surveys and databases, to support data capture for research studies. The team anticipates further expansion of the data marts during phase 3, with increased patient volume and depth of data.

In addition to its involvement in the ADAPTABLE aspirin dosing study and the ACTIV-6 drug repurposing initiative, the STAR CRN has led or participated in more than 100 funded studies, including:

  • PCORI Obesity Demonstration Projects, which included studies to examine electronic health data to evaluate the effectiveness of different approaches to bariatric surgery, and the relationship between antibiotic exposure and pediatric weight gain.
  • PREVENTABLE, a $90-million study funded by the NIH to assess the ability of statin drugs to prevent dementia and other disabilities in older adults who do not have cardiovascular disease.
  • The Healthcare Worker Exposure Response and Outcomes (HERO) program, a registry of more than 50,000 U.S. health care workers, and an accompanying study of whether the anti-malarial drug hydroxychloroquine (HCQ) protected health care workers from COVID-19. Results of the study have not yet been published in a peer-reviewed journal.

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