To address the challenge of finding participants for the nation’s highest priority clinical trials, the National Center for Advancing Translational Sciences invited the Atlanta Clinical & Translational Science Institute (ACTSI), along with 12 other Clinical and Translational Science Awards, to leverage the nation’s recent investment in electronic health records to increase recruitment (accrual) to trials. All too often, health-related research studies that could offer new treatments or cures are forced to end before completion because researchers cannot find enough people to participate.
ACTSI is a city-wide partnership between Emory University, Morehouse School of Medicine (MSM), and Georgia Institute of Technology. It is one of 62 in a national consortium striving to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. The consortium is funded through the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) and the Clinical and Translational Science Award (CTSA) program.
As an organization that aims to expedite the translation of healthcare discoveries to patients, ACTSI has invested in an i2b2 data warehouse system with feeds from the electronic health records of Emory Healthcare and Morehouse HealthCare. I2b2 is an emerging standard for enabling researchers to identify patients for clinical studies rapidly from their web browser. ACTSI also plans to adopt SHRINE, a technology that links i2b2s across many institutions so that researchers may determine rapidly which hospitals and clinics may have potential research participants for a study. Using SHRINE and i2b2, ACTSI will join with other leading academic medical centers in creating research data networks to support local and national researchers.
ACTSI is a founding member of the CTSA Accrual to Clinical Trials (ACT) group, which is building a research data network to increase accrual to clinical trials. Stage one, completed in June, created the infrastructure for sharing Emory and MSM data with participating CTSA institutions. Stage two will use the infrastructure to identify, contact, and enroll patients in trials and address policy issues. Finally, stage three will include tools, educational materials, and infrastructure for patients and care providers to identify clinical trials. This effort is led by CTSAs at University of Pittsburgh, Harvard, University of Texas Southwestern, and University of California San Diego.
“ACT and other networks are providing direct access to electronic health record data for research that is secure, rapid, accurate, low-cost, and respectful of patient privacy. These networks will enable a far more effective partnership between investigators and patients interested in participating in research that will accelerate the testing of new therapies,” said Andrew Post, MD, PhD, director, ACTSI Biomedical Informatics Program and associate professor, Department of Biomedical Informatics, Emory University. Read More
The National Patient-Centered Clinical Research Network (PCORnet)
The Patient-Centered Outcomes Research Institute (PCORI) and the CTSA program both have similar recruitment goals. Through a partnership with Harvard Medical School, MSM, and Grady Health System are part of the Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS), which is one of the 11 Clinical Data Research Networks (CDRNs) of the National Patient-Centered Clinical Research Network (PCORnet) funded by PCORI. The SCILHS CDRN comprise 10 health systems/sites, with Elizabeth Ofili, MD, MPH as the site Principal Investigator and Alexander Quarshie, MD as the site Project Implementation lead for the MSM/Grady site.
The SCILHS network also uses i2b2 and SHRINE and is developing the capacity to conduct randomized comparative effectiveness studies using data from clinical practice in a large, defined population. “PCORnet is building the infrastructure needed to boost the nation’s capacity to conduct clinical outcomes research that will produce data allowing patients and their caregivers to make better-informed health and healthcare decisions,” said Elizabeth Ofili, MD, MPH, senior co-principle investigator, ACTSI, chief of Cardiology, and professor of medicine, Morehouse School of Medicine. Read More
ACTSI is working with Emory University and MSM to make i2b2 internally available to investigators while national CTSA collaboration is in further development. Researchers will be able to request access to the website containing local data, and query to get counts of potentially eligible participants. “Our engagement with ACT and PCORnet will help ACTSI and its partners to better engage in health services research and clinical trials and to rapidly translate scientific discoveries to impact all populations of the Atlanta community and beyond,” said David Stephens, MD, Principal Investigator, ACTSI and Vice President for Research, Robert W. Woodruff Health Sciences Center, Emory University.
Contact Andrew Post (firstname.lastname@example.org) for more information.