It is commonplace for the leaders of academic medical centers to articulate their mission as a “three-legged stool” comprised of patient care, research and education. But how often are those components all given equal importance when it comes to IT strategy? The reality among academic hospitals and health systems is that the information systems supporting clinical research generally lag far behind those supporting patient care, in terms of funding and interoperability.
But that reality is changing, as new IT tools are developed and enhanced, and even more importantly, as academic medical centers accelerate their efforts to compete for lucrative research dollars. Today, CIOs and other senior executives are developing new strategies to support clinical research with information technology.
One of the best examples of a pioneer in this area is the massive Cleveland Clinic Health System in Ohio (with its nine owned and three affiliate hospitals and 13 clinics). At the Cleveland Clinic, executives and managers, led by CIO C. Martin Harris, M.D., have created an organizational structure to ensure that clinical research gets priority treatment along with patient care and teaching. Harris has directors of those three teams reporting to him.
Out of that structural development work has come an e-research initiative during the past two-and-a-half years. Three capabilities are involved: recruitment, feasibility analysis, and reporting. What's more, Harris says that he and his colleagues have been aiming for a good balance in supporting all three areas with IT.
“We are an academic organization,” Harris emphasizes. “Obviously, patient care is first for us, but the other two legs of the stool for us are research and education. And clinical research plays a role in generating new knowledge, and converting that new knowledge into innovations that we can apply to patient care.”
Robert DiLaura, D.B.A., director of research informatics and computer systems for Cleveland Clinic, observes, “Clinical research is usually the orphan of the healthcare institution; it is underfunded, with little governance. So what happens in many institutions is that the IT organization may be called on to support some of the server, network, and infrastructure of research, even though they don't understand the informatics of it. (They don't understand how to get) the right information, the right way, to drive research and science.”
Fortunately, the Cleveland Clinic organization has a core inpatient and outpatient EMR (from Madison, Wis.-based Epic Systems Corp.), as well as an IT staff dedicated to clinical research support. Cleveland Clinic's clinical research operation also benefits from the evolution of software packages from commercial vendors such as the Fremont, Calif.-based Velos (which Cleveland Clinic and numerous other major academic medical centers are now using, in concert with other tools).
DiLaura says his colleagues went through a thorough vetting process when they chose the Velos solution (which had just been selected when DiLaura arrived at the organization a few years ago). At the time of that selection, there were almost no truly robust commercial solutions in this area, DiLaura notes (indeed, it is a situation that continues to the present, he adds, though Velos appears to be the most robust in the market).
At the moment, DiLaura and his colleagues are pulling demographic patient data from their Epic EMR into Velos, but nothing is integrated yet, though he is examining the potential for using Velos as a kind of integrative platform for the numerous vendor solutions being used at a very micro level in individual clinical trial studies.
National funding spurring informatics
In addition to support from executive management and IT teams, research directors like DiLaura are also benefiting from a major federal funding program that is strongly impacting the path of informatics around clinical research nationwide.
The National Institutes of Health (NIH)'s Clinical and Translational Science Award (CTSA) program, operated via the NIH's National Center for Research Outcomes (NCRO), has enrolled 24 academic medical centers around the United States, and is expected to enroll more over time. The program, established in 2006 (for details, go to http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/) is helping to consolidate funding for clinical research nationwide. The NCRO hopes to ultimately enroll 60 institutions in its consortium. Some of the funding coming out of the CTSA program is already spurring greater IT investment and inter-organizational cooperation around clinical research informatics, according to DiLaura and others at CTSA sites.
What's more, all of this is one element in an exciting, if still-emergent, trend: the move towards truly integrating clinical information systems for patient care with those for research. Those involved in using IT to support clinical research are excited by all the potential and looking forward to addressing the challenges.
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