To learn what works best in HIV/AIDS therapy, researchers must study a universe of variables, including unprecedented drug combinations and vastly differing ways in which patients respond to treatment. Now, for the first time, this critical outcomes research will be collected and analyzed through a national electronic clinical data network centered at the UAB Center for AIDS Research (CFAR).
The National Institute of Allergy and Infectious Diseases (NIAID), in conjunction with the National Heart, Lung and Blood Institute (NHLBI) — both part of the National Institutes of Health (NIH) — has given the UAB Center for AIDS Research a $2.45 million grant to build and manage an information-sharing network that will support outcomes research through the merger of electronic clinical data from seven centers for AIDS research across the country.
NHLBI made the award through its Resource-Related Research Projects program that supports studies to enhance the capacity of resources that serve biomedical research. It is expected that this effort will inform AIDS research investigations beyond the members of the CFAR community.
“This is a new paradigm for clinical investigation – in essence, a way to study every patient outcome as compared to studying only selected patients, as is done in clinical trials,” says principal investigator Michael Saag, M.D., UAB professor of medicine and director of the UAB CFAR. “Long-term outcomes research is necessary to provide clinicians with up-to-date information on the best strategies to treat patients. By merging electronic data from clinics nationwide, we create a body of information that is discreet, analyzable and reliable. It’s the first formal way to track HIV/AIDS treatments and outcomes on a broad, comprehensive scale and do it in real time.”
The six CFARs partnering with UAB on this project are at Case Western Re-serve University, Cleveland; Harvard University, Boston; Johns Hopkins University, Baltimore; University of California, San Diego; University of California, San Francisco; and the University of Washington, Seattle.
All seven centers already had databases that tracked the clinical outcomes of their individual patients, Saag says, but were lacking a collaborative, interactive, information-sharing network on a national level. The new network allows the seven CFARs to combine all of their data to track clinical outcomes and also gather information on other factors that affect treatment outcomes, such as lifestyle, quality of life and substance use.
Saag explained how the information is collected: “In each center, there will be kiosks in waiting rooms. Patients will spend 8 to 10 minutes answering questions about everything from symptoms they may be experiencing to their body image and adherence to medication regimens; but, because this data is used for outcomes research, individual patient identification information is not included,” he said. “This quality-of-life information will be incorporated into the outcomes platform, along with specimens collected from each patient. All this material and information then can be interfaced in real time between the clinics and the basic research scientists to look at how HIV influences the development of AIDS and disease progression.”
The network provides a unique resource for HIV clinical, translational and basic research through new infrastructure and ready access to data addressing rapidly evolving issues in HIV care and research. One of the most interesting aspects, Saag says, is the ultimate ability of networks like this to take the information collected in the clinic and input it into “decision assist” software that uses computer calculations to suggest the treatments that have the best chances of working, based upon what has helped patients from across the country with similar clinical presentations.
“This type of network is the future of HIV/AIDS clinical research during the next several decades and points the way for clinical outcomes research and treatment programs for many other diseases, as well,” Saag says.