Watkins, Paul B.

Biomedical Informatics Core

The TraCS Biomedical Informatics Core will unite the silos of biomedical informatics research excellence at UNC and across North Carolina to maximize re-use of data, knowledge and processes. With the establishment of the North Carolina Collaboratory for Biomedical Informatics (NCCBI), TraCS will support research, patient care, education and policy-making while building upon, leveraging and extending the current biomedical informatics infrastructure at UNC-CH. This core involves several external partners with a strong presence in NC and world-wide: Red Hat, IBM, SAS, Allscripts, Quintiles and NCHICA. We are committed to achieving a national leadership role in the design and development of best practices for the inclusion of clinical data into shared repositories of biomedical data.

A. Biomedical Informatics Core Leadership

Investigators: The following investigators will form the leadership of the Biomedical Informatics Core through membership on the NCCBI UNC-CH Steering Committee:

Jose-Marie Griffiths, PhD, TraCS Biomedical Informatics Leader and Dean, School of Information and Library Science (SILS), is a member of the National Science Board and a Fellow of the American Association for the Advancement of Science, and co-authored Revolutionizing Health Care Through Information Technology while serving asa member of the President’s Information Technology Advisory Committee.

Tim Carey, MD, Professor of Medicine and Director of the UNC-CHShepsCenter for Health Services Research, is an accomplished Type 2 Clinical Investigator with extensive experience with health care data bases. He is a member of the TraCS Translational Research Advisory Board and chair of the Type 2 Translation Subcommittee.

Ronald Falk, MD, Professor of Medicine, Chief, Division of Nephrology, is an accomplished clinical and translational researcher who has successfully merged data from UNC electronic medical records with his research data. He directs the Glomerular Disease Collaborative Network which includes over 400 nephrologists throughout the Southeast United States.

Bradley Mark Hemminger, PhD, Assistant Professor, joint appointment in School of Information and Library Science and the CarolinaCenter for Genome Sciences; Adjunct Assistant Professor, Department of Radiology, School of Medicine, will co-lead the Educational Opportunities Working Group. He has conducted an extensive needs assessment with bioinformatics researchers at UNC-CH and is working on the development of a unified vocabulary to support data access.

Carol Jenkins, MLS, Director, Health Sciences Library, will work with SILS to design support services for the NCCBI. Ms. Jenkins chairs the UNC-CH campus-wide Information Technology Strategic Planning Committee.

John P. Kichak, Vice President, Information Services Division of UNC Hospitals, will direct the development of the WebCIS data warehouse and provide significant leadership in the development of the NCCBI.

Lisa LaVange, PhD, Professor of the Practice of Biostatistics in the School of Public Health and director of the CollaborativeStudiesCoordinatingCenter, will lead the NCCBI Data Management Initiative. She joined UNC after 10 years in industry and brings extensive experience in clinical data management and statistics to the TraCS Institute, with a particular emphasis on trial design, data management and analysis in a regulatory environment. She is a Co-PI of this CTSA proposal and an associate director of the TraCS Institute.

Terry Magnuson, PhD, Sarah GrahamKenan Professor and Chair of Department of Genetics, director of the CarolinaCenter for Genome Sciences Program and director of Cancer Genetics, LinebergerComprehensiveCancerCenter, will provide leadership in building the TraCS-facilitated Translational Genomics Research Initiative.

Chuck Perou, PhD, TraCS Biomedical Informatics Core Co-Director, Assistant Professor, Department of Genetics with a research focus in cancer molecular genetics, will lead the Translational Genomics Research Initiative.

Russell Taylor, PhD, Research Professor, joint appointment in the Department of Computer Science and the Department of Physics and Astronomy, will co-lead the Educational Opportunities Working Group.

Daniel Reed, PhD, founding director of the Renaissance Computing Institute, Chancellor’s Eminent Professor Vice Chancellor for Information Technology, and UNC-CH CIO is a member of the President’s Council of Advisors on Science and Technology, Chair of the Board of Directors of the Computing Research Association and member of the Biomedical Informatics Expert Panel for the NIHNationalCenter. Dr. Reed was formerly director of the NationalCenter for Supercomputing Applications (NCSA) and, while a member of the President’s Information Technology Advisory Committee, co-authored their report, Revolutionizing Health Care through Information Technology. Hewill lead the integration of the Portal into NCCBI and provide design leadership.

External Partners:UNC-CH is in close geographic proximity to several leading information technology companies which will work together with us to define the parameters of this ambitious project, helping to identify the milestones and contribute intellectual capital to its achievement. These companies include:

Red Hat – the leading open source software company will provide intellectual guidance on anopen source architecture, help populate the international advisorycouncil for the NCCBI and connect us with related global open source activities.

IBM – has relationships with UNC-CH through its research labs worldwide and its healthcare and life sciences solutions group located in Research Triangle Park, NC. Preliminary discussions related to the biomedical informatics core have focused on the National Health Information Network and Health Information Exchange, bioinformatics research and underlying architecture for the NCCBI cyberinfrastructure.

SAS – the statistical software company is currently engaged in discussions to develop the UNC Health Care System research data warehouse. The company is also world-class in the area of analytics – an important component of biomedical informatics.

Allscripts – provides software for maintaining electronic health records. Allscripts is in the process of developing a data warehouse for many millions of patients and plans to make available its electronic health records to the shared repository, thereby enhancing the potential to enroll research subjects into clinical trials.

Quintiles –will assist in clinical data and policy issues through the participation of Judith Beach, a nationally recognized expert on HIPAA, and via other in-kind support.

North Carolina Healthcare Information and Communications Alliance (NCHICA) –isa nonprofit consortium of over 220 organizations dedicated to improving healthcare statewide by accelerating the adoption of information technology.

B. Vision

The history of science has taught us that the more broadly and transparently scientific data, knowledge and processes are shared and re-used, the stronger the science and the faster the rate at which the science advances. Activities over the past decade have leveraged public infrastructure and open access to better practice of science itself through, for example, the National Library of Medicine’s National Center for Biotechnology Information (NCBI), a resource for molecular biology information. NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data and disseminates biomedical information. Of particular significance for its usability and functionality is Entrez, NCBI’s cross-database search engine, toolkits and educational programs. The TraCS Biomedical Informatics Core will use this basic framework and infrastructure as a model to build an Entrez-like data system for clinical data, which may come from clinical trials and studies, actual patient care or both.

The problem of collecting, cataloging, protecting, sharing and reusing clinical data is a non-trivial one, but it is a problem that also contains its own solution. As the Entrez system teaches, the solution comes not by designing the system around the method of collection or the structure of the catalog, but rather from thinking about how to maximize the nature and the number of ways that data can be properly shared.

UNC-CH, along with its partners in government, healthcare and industry, is well-positioned to make this vision a reality, with measurable implementation milestones. Several recent developments at UNC-CH confirm the institutional commitment to build collaborative and far-reaching biomedical informatics activities:

  • A Bioinformatics planning group, led by Dean Jose-Marie Griffiths and comprised of representatives from the UNC-CH Schools of Medicine, Public Health, Dentistry, Nursing, Pharmacy, Information and Library Science and the Department of Computer Science, has been working for the past 2 years on plans for integrated health informatics education and related research. This effort has provided the foundation for the TraCS Biomedical Informatics Core.
  • UNC Health Care System is in the process of planning for a research data warehouse that will facilitate access to clinical and administrative data for research purposes.
  • The Renaissance Computing Institute (RENCI), founded in 2004, is a major collaborative anchored at UNC-CH and supported by North CarolinaStateUniversity and DukeUniversity. One of RENCI’s primary foci is integrating information technologies for applications to biology, biomedicine and genomics.
  • NCHICA (NC Healthcare Informatics Work Group) led by David Potenziani, Director of Information Technology and Adjunct Assistant Professor, UNC School of Public Health, is assisting with the re-tooling and transformation of the currently fragmented NC healthcare community from largely paper-based records to an interoperable federated system of electronic information to improve healthcare.
  • Strong relationships exist among UNC-CH’s School of Information and Library Science, Department of Computer Science, Red Hat and IBM, especially in development and dissemination of open source software, open access digital libraries, knowledge representation, computer modeling and visualization.

To support the goals of the TraCS Institute, the Biomedical Informatics Core will create a statewide interdisciplinary and inter-institutional collaboratory (collaborative laboratory): the North Carolina Collaboratory for Biomedical Informatics (NCCBI). It will build on the transformative technology used by the NIH to create Entrez for the NCBI. The long-term goal is to create a shared biomedical informatics data repository connecting clinical enterprises across the State of North Carolina to create a demonstration project for clinical data that will be a model for sharing and re-use of clinical data. This repository will contain appropriately de-identified data from clinical trials and clinical care. With the establishment of the NCCBI, the TraCS Biomedical Informatics Core will transform the excellent but fragmented biomedical informatics capabilities at UNC-CH into a coherent and connected system that facilitates routine re-use of research knowledge, data and processes throughout UNC and North Carolina, serving as a prototype for the nation.

An effort of this magnitude stems from the rapidly emerging and urgent need to enhance and promote a culture of collaboration among researchers, clinicians, information technologists, educators, consumers, payers, and others. This requires fostering and sustaining interdisciplinary collaboration across traditional boundaries; managing large and diverse data sets generated by a variety of methods from different disciplines; mining and analyzing these data with advanced statistical, mathematical and computational techniques; and developing robust, user-friendly tools and services for a variety of stakeholder constituencies.

The construction of the NCCBI will require funding that exceeds existing and proposed resources and will require years of dedicated work. UNC-CH is committed to seeking the necessary funds from the private as well as the public sector to realize this vision.

C. Specific Aims

The TraCS Biomedical Informatics Core has identified 7 specific aims or requirements that we believe we must effect to leverage and facilitate the power of re-use and transform biomedical informatics at UNC and ultimately across North Carolina.

C-1. Improved collaboration among researchers, clinicians and educators. Effective collaboration results from a combination of social, organizational and technical strategies and processes. Achievement of this aim will require extensive user involvement, change management, promotion of sharing and collaboration, development of effective processes and tools to address specific problems and adoption of standards.

C-2. Improved ability to search for clinical data and re-use with other research data. A critical step in achieving this aim is to implement a research data warehouse for accessing UNC Health Care System electronic health records and other clinical and administrative data. The end result of this project will be a secure, searchable data repository with capabilities to download clinical care data for integration with other research databases, including databases from primary data collection efforts under TraCS protocols.

C-3. Improved data mining and analysis capabilities to facilitate re-use of genomic and clinical data. This objective will be accomplished through the expansion of the widely recognized bioinformatics center at UNC’s LinebergerComprehensiveCancerCenter to develop a network through which genomic research centers across campus can be linked to each other, to clinical care databases and to other research databases.

C-4.Clinical research data management systems that are re-usable and scalable across varied research protocols. We will draw upon existing clinical research data management resources in the current GCRC and the CollaborativeStudiesCoordinatingCenter, integrating and expanding resources and tools to enable more efficient and accurate real-time data collection, processing, management and analysis for TraCS research protocols.

C-5. Flexible data collection procedures and tools that will support patient quality-of-care analyses as well as facilitate subject recruitment for future research studies. This initiative will provide high quality clinical databases populated with information collected from consenting, treatment-seeking patients in the UNC Health Care System and, ultimately, throughout North Carolina to facilitate analyses of patient quality of care as well as greatly shorten the length of time required to screen and enroll patients as subjects in future research protocols.

C-6. Expanded community engagement. We will build on existing relationships with the broader biomedical community, described more fully in the Community Engagement Core. Achievement of the aim will be based on community biomedical informatics needs, priorities and perceived barriers to participation in collaborative activities, the capture and accumulation of data in a shared and appropriately secure repository, availability of a variety of tools for accessing, analyzing and re-using the data and development of targeted user portals, and registries and educational programs aimed at multiple audiences.

C-7. Coordination of research infrastructure designed for re-use of data, processes, tools and

services. We will include design, development, testing and implementation of a biomedical informatics cyberinfrastructure that includes a shared data repository; reusable processes, protocols, tools and applications and a variety of user services.

D. Detailed Vision

D-1. Improved collaboration among researchers, clinicians and educators:

Establishment of the North Carolina Collaboratory for Biomedical Informatics

Overview: Engaging the power of re-use requires significant and challenging behavior changes among researchers. First and foremost among these is the development of a culture of collaboration. The NCCBI will establish the social, organizational and technical framework needed to promote and sustain this new high level of collaboration. This initiative will draw upon investigators’ experience in developing and sustaining successful interdisciplinary collaborations.

Problem Statement: There are many areas of excellence in biomedical informatics at UNC-CH. Strong groups of researchers and clinicians use the most modern informatics tools and data sources available but they lack awareness of the full range of activities and capabilities, and an adequate infrastructure to support sharing and collaboration, and they experience a collaboration culture that is not as interdisciplinary or routine as it might be. This results in suboptimal use of existing resources, duplication of effort, and lost opportunities. There exists a critical need for coordination across organizational units to 1) expand awareness of the wide range of relevant biomedical informatics activities and resources; 2) foster and support effective, efficient and routine re-use of research knowledge, data and processes; and 3) stimulate the development and dissemination of new ideas. However, new collaborations are not easy to build and sustain, especially when they cross multiple disciplines and institutions. They need deliberate and focused effort and must deliver clear and immediate value to those participating through demonstrated convenience, usability, reward and recognition.

What Do We Have to Build Upon? The current biomedical informatics infrastructure and leadership at UNC-CH provide a substantial base on which to build the work of the NCCBI. UNC-CH has significant ongoing activities in biomedical informatics,(described in more detail subsequently).However,there exists a critical need for coordination across both databases and UNC-CH schools and research centers to stimulate and support effective and efficient clinical and translational research. Strong, yet insulated and separated groups of researchers and clinicians use the most modern informatics tools available but need the people, software and tools to link disparate databases together and to help people identify new opportunities for collaboration.

To date, UNC-CH has established a number of focused interdisciplinary research centers with varying degrees of informatics capabilities activities: the General Clinical Research Center, the Collaborative Studies Coordinating Center, the Lineberger Comprehensive Cancer Center, the Carolina Center for Exploratory Genetic Analysis, the Carolina Center for Genome Sciences, the Carolina Exploratory Center for Cheminformatics Research, the Biomedical Imaging Research Center, the Carolina Environmental Bioinformatics Center, the Center for Bioinformatics, the Renaissance Computing Institute, and the Odum Institute for Research in Social Science, among others. These centers engage faculty, staff and students or schools and departments at UNC-CH and occasionally from other UNC institutions. Each of these centers has been successful in its own right, but each could potentially contribute to an institution-wide or broader research infrastructure, leveraging critical mass and specialized resources.