Amy Jones, M.S., often studies at a back table at Cheers in the Heights restaurant in Little Rock, where she also waitresses. Over the years she’s come to know the regulars, who include UAMS physicians and researchers.
They’ve watched her grow up there, she said, and they have always encouraged her scholarship. Last summer when she mentioned her plans to apply for UAMS’ new Clinical Research Informatics Certificate program, she got an enthusiastic response from a UAMS faculty physician based at Arkansas Children’s.
“You need to run, not walk towards that opportunity,” he told Jones.
The demand for clinical research informaticists is exploding, and UAMS last fall became the first in the United States to offer a full curriculum in clinical research informatics, with the certificate and master and doctorate degrees. The degree program is offered by the Department of Biomedical Informatics in the College of Medicine with support by the UAMS Translational Research Institute (TRI).
Today Jones is part of the seven-student inaugural graduate certificate class.
“We’re excited,” said Meredith Zozus, Ph.D., who led development of the curriculum as associate professor and vice chair for academic programs at the Department of Biomedical Informatics in the College of Medicine. “It’s a really big deal at UAMS, and it’s an advance for TRI – our CTSA (Clinical and Translational Science Award) Program.”
The NIH’s National Center for Advancing Translational Sciences (NCATS) has tasked its 62 CTSAs with making the translational research cycle spin faster. CTSAs are also looking for ways to improve reproducibility of study findings, an issue that received negative publicity nationally in 2015.
Clinical research informaticists could play key roles on both counts. Graduates of the program will learn to design data collection and management processes for clinical studies. Their efforts are a large part of:
- Ensuring that data are of sufficient quality to support study conclusions
- Ensuring data are documented and archived properly so study findings are reproducible
- Integrating clinical research with ongoing clinical care
- Ensuring data quality control in compliance with federal regulations
A Dance
The clinical research informatics program trains professionals to work with investigators to identify the best data source and to design a data flow and a work flow to best capture and clean that information in a way that keeps the translational research cycle turning. It also trains how to integrate clinical care and clinical research.
For example, a clinical research informaticist would work with researchers and clinicians to devise data capture within routine care through Epic or devices so that one capture of data serves multiple purposes.
“Patients in trials are people in health care, and the research cycle has to operate within health care,” Zozus said. “There’s a dance that has to be choreographed between the data flow and the work flow and between the processes needed for the clinical study and the processes ongoing anyway in the health care environment.”
Wild, Wild West
Zozus said a wake-up call came in 2015 when the journal Nature reported that over half of psychology studies failed reproducibility tests. In addition to the fact that most researchers aren’t trained in data handling, she said the story put a spotlight on another issue in academic research.
“It’s kind of the wild, wild West because the authority and autonomy of individual investigators is so respected in academia, very few institutions have set expectations or standards for documenting or managing research data,” she said. “And today, these activities are undertaken by individuals with varied education and skills.”
Few universities have policies for archiving and maintaining study data, Zozus said. “I think NCATS would like to see its CTSAs fix the research reproducibility issues, and there are now efforts to do so.”
Other Informatics Tracks
The clinical research informatics track is one of four tracks in the new biomedical informatics graduate degree program offered at UAMS. Other new tracks are:
- Translational bioinformatics
- Imaging informatics
- Clinical informatics
Fred Prior, Ph.D., professor and chair of the Department of Biomedical Informatics, said the beefed-up curriculum is helping fulfill his vision for a nationally recognized graduate program. It also addresses key clinical and research workforce issues in Arkansas, benefiting students like Jones.
Jones said she’s excited to see where her new clinical research informatics skills will lead. She envisions working in clinical trials in a collaborative environment.
“I have a strong biology background, and some students have strong computational backgrounds,” she said. “That’s the way the real world works, too, especially in science and research. You have to collaborate and use people’s strengths, and the UAMS faculty have been encouraging us to do that.”
More information about the specialty tracks is available on the Department of Biomedical Informatics website, dbmi.uams.edu/education/graduate-programs.