Innovative Paradigm for Clinical Investigation

To assess efficacy, durability, and adverse event risk in HIV/AIDS therapy, researchers study a wide range of variables, from unprecedented numbers of drug combinations to new classes of drugs with novel targets. Because patients infected with HIV respond to treatment in subtle and variable ways, clinical outcomes research provides a valuable tool for informed treatment decisions.

A national electronic data network headed by UAB’s Center for AIDS Research (CFAR) will facilitate such research. The CFAR Network of Integrated Clinical Systems (C-NICS) is a National Institutes of Health (NIH)-funded information sharing network that supports outcomes research by merging clinical data from seven CFARs, including UAB, the University of Washington, the University of California, San Diego, the University of California, San Francisco, Case Western Reserve University, Johns Hopkins University, and Harvard University. NIH awarded UAB $2.45 million over 5 years to build and manage the network.

“This is the first attempt to track HIV/AIDS treatment outcomes on a broad, comprehensive scale in real time,” says C-NICS principal investigator Michael S. Saag, MD, an internationally known HIV/AIDS expert and director of UAB’s CFAR and Division of Infectious Diseases.

C-NICS will collect confidential, clinical data on 15,000 patients and pair that information with lifestyle and quality-of-life measures harvested from computerized questionnaires in waiting room kiosks to form a unique, ongoing electronic data set. Patients will assess symptoms, body image, mental health status, substance use, adherence to medication regimens, and more. A data dictionary will link synonymous verbiage to key terms for uniform reporting.

“These data will define the natural history of HIV in the effective-therapy era,” says Saag. The standardized electronic data will capture patterns of adverse events, complications, resistance, and treatment response patterns, enabling clinicians to prescribe treatment regimens based on historical success for an individual patient’s symptoms and needs. Ultimately, Saag plans to use decision-assist software to recognize patterns of success and suggest the best regimen for each patient.

C-NICS’s electronic data sharing will likely change the way doctors investigate clinical issues, Saag says. When equipoise about treatment choice exists, investigators can randomize and collect study data during regular patient visits. “We are merging routine patient care with research, such that every patient, in essence, becomes a study participant,” he says. “This new paradigm allows us to assess every patient’s outcome and compare with similar cohorts.”

Traditional randomized controlled clinical trials provide limited information because of small cohorts, short-term follow-ups, and restrictive inclusion/exclusion criteria and outcome measures. Standardized C-NICS data will be more inclusive, easily merged and analyzed, and amenable to trend tracking. “The data will facilitate faster analysis of questions as they emerge,” he says. C-NICS will share data liberally with AIDS researchers worldwide. “This network sets the standard for future HIV/AIDS clinical investigations and serves as a model for clinical outcomes research for many other diseases,” says Saag.

For more information:
Dr. Michael Saag
1.800.UAB.MIST
mist@uabmc.edu