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New integrated research database helps researchers quickly test hypotheses

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Story - MICARD Ralph Zottola, PhD, associate chief information officer for Academic and Research Computing Services

Clinical and Translational Science Awards (CTSA) were created by the National Institutes of Health to do something very  specific: accelerate the process of turning research science and data into therapeutics. Far from being research as usual, these grants help the nation's top research institutions create programs and infrastructure that will speed research discoveries into medical practice. Instead of funding solitary investigators in a laboratory, these grants put the tools for fast-tracking cures and treatments into the hands of researchers collaborating across institutions and across the country.

One of the most exciting examples of these tools at UMass Medical School is a new integrated clinical research database, created jointly by UMMS and its clinical partner, UMass Memorial Health Care. The Massachusetts Integrated Clinical Research Database, known as MICARD, helps researchers overcome one of the key obstacles facing physicians and clinicians who want to test research questions and hypotheses rapidly and efficiently: how can a researcher, in his quest for medical breakthroughs, determine if there are patients who meet potential study criteria in an environment where patient records are tightly protected and access is rightfully regulated?

"Before informatics tools like MICARD, a clinician who was interested in exploring a research question had no way of efficiently compiling large groups of well-characterized patients," said Ralph Zottola, PhD, associate chief information officer for Academic and Research Computing Services. "For clinicians interested in determining whether there was a cohort of patients who met certain criteria, the process could take months."

MICARD, based on an informatics program originally developed at Partners Health Care, has changed this. "The result of our collaboration with UMass Memorial means that qualified investigators may use the MICARD tool to determine whether there are patients who have been treated at UMass Memorial who meet clinician-specified criteria," said Dr. Zottola. That criteria includes demographics, diagnoses, medications and laboratory values. Because the patient counts are collected together from different sources and stripped of identifying information, patient privacy is protected—in fact, increased—and the process is streamlined.

The Partners tool—known as i2b2, or Informatics for Integrating Biology and the Bedside—was developed to enable researchers to use existing clinical data for discovery research and ultimately facilitate the design of targeted therapies for patients with diseases having genetic origins. MICARD, UMMS' implementation of i2b2, offers UMMS researchers a tool to quickly generate new research hypotheses and identify potential cohorts for clinical trials. It also serves as a resource to catalog biological samples from the UMMS Conquering Diseases Biorepository. Such efficient access to data points is key to preparing grant applications that would benefit from pre-identification and/or characterization of a potential research cohort, said Zottola.

"Even more excitingly, MICARD will enable us to federate with other institutions using the i2b2 platform, increasing a researcher's ability to identify potential cohorts for rare diseases and increase the potential for collaborative studies," he said. The MICARD system already contains more than 270 million discrete, de-identified facts available for query by researchers. Work is ongoing to add more data sources to make this a richer system for translational research.

"MICARD is one component of our translational research IT strategy. UMMS also made significant investments to increase the capacity and security of the data center to support clinical research. UMMS researchers also have access to the REDCap software platform for electronic data capture," said Zottola. REDCap was developed at Vanderbilt University and provides a streamlined process for building study-specific clinical research databases and surveys. The REDCap Consortium is comprised of 127 institutional partners across the world.

Work on MICARD and related tools useful for accessing databases of clinical information began more than two years ago. By working with UMass Memorial and the research and clinical leadership, UMMS was able to construct a system that permits fast and intuitive access to information useful in testing research hypotheses, while tightly protecting patient privacy and preserving data integrity. Excitement surrounding these bioinformatics tools and the CTSA was evident at a recent forum aimed at introducing faculty to MICARD and its potential: nearly 100 faculty filled the UMMS Faculty Conference Room for the rollout of these new tools.