Substantial value has been derived from obtaining the IAIMS grants at COH. As a financial resource the implementation grant provides leverage for significant cultural changes in the strategic direction and management of information. Not only has it provided external validation to our tactical directions, but the grant has promoted information integration as a key institutional priority.

The IAIMS grant provided the impetus and seed funding to create a Department of Biomedical Informatics in 1998. This Department is joined with the Department of Biostatistics under a new Division of Information Sciences, providing core resources and scientific collaboration for both basic and clinical research. After building this group to 35 staff and faculty members, in 2002 we acquired a new building to provide an additional 14,000 square feet for Information Sciences. As another result of the IAIMS funding, the Chair of Information Sciences (J. Niland, IAIMS Principal Investigator) now is included as a member of the Clinical and Scientific Executive Team of COH, a group that provides institutional leadership and global strategic planning to COH. The Division works in close collaboration with the Information Technology Services Department of COH through the CRIIS Steering Committee process that has been in place since the IAIMS planning grant.

Additional national collaborations and funding have resulted from the IAIMS springboard. This includes COH being selected as the Data Coordinating Center for the National Comprehensive Cancer Network (NCCN) Outcomes Research study. Beginning in 1997, COH developed an Internet-based data system to collect, manage, and analyze data within a central repository, now containing treatment and outcomes data on over 10,000 subjects from 12 national cancer centers.

Other informatics initiatives awarded to the Division of Information Sciences include a one-year Cancer Center supplement grant to extend outcomes research to the community setting (ORCOS: Oncology Research in the Community Oncology Setting), and a $3 million grant to develop a unified information structure for clinical research from the National Clinical Research Center (NCRR). This project, titled FIRST: Fully Integrated Research Standards & Technology project) will result in a system to be extended to the General Clinical Research Centers (GCRC) program nationwide. Most recently COH was awarded a grant from the NCRR to serve as the Administrative and Bioinformatics Center (ABCC) of a national research project in islet cell transplantation for insulin resistant diabetes.

Further leverage from IAIMS has resulted in COH's participation in numerous national informatics forums, including the National Cancer Institute Long Range Planning Committee, the Association of American Cancer Institutes Informatics Subcommittees, the National Library of Medicine Biomedical Library and Informatics Review Committee, and the American Medical Informatics Association Clinical Trials Working Group. COH has become the organizing agent for multiple GCRC Biomedical Informatics training programs and workshops, including one held at NIH in October 2003 entitled “Information Integration: the Next Frontier.”

Specific Aims of CRIIS: The following summarizes activities in 2001-2002 related to the 3 specific aims of the COH IAIMS grant.

Specific Aim 1: Create integrated information resources to support the patient care, clinical research, educational and administrative functions at COH.

1.1 Continue building an electronic medical record (EMR) to facilitate high quality patient care. The Oacis EMR has been in place at COH for 10 years. As this vendor is no longer supporting this product, the Oacis EMR is being replaced by a full Clinical Information System (CIS).  The CRISS Steering Committee will make the final decision on the new CIS.

1.2 Integrate the EMR with other systems needed to support patient care and clinical research activities. Until a new CIS is selected and installed to replace Oacis, the Division of Information Sciences has worked with ITS to obtain an interface to the existing electronic repository of patient data, refreshed every 24 hours for integration with our clinical research system. An overview of evidence-based medicine tools were presented by Elizabeth Wood, Information Scientist and Director of the Graff Medical Library, to assist in the development of clinical decision support systems in conjunction with the CIS. A new 7-story Helford Clinical Research Hospital is under construction and is scheduled to open in the spring of 2004. The design includes data and video networks to assist increased collaboration among researchers and clinicians.

1.3 Build an enterprise-wide research data warehouse to support translational, clinical trials, outcomes and marketing research. Challenges in data integration are being addressed by readying several feeder systems for the future research data warehouse. The Biostatistics Information Tracking System (BITS), developed in 1989 to manage all protocol and research participant data at COH, has been migrated to a MS SQL Server database system, with Web front ends being deployed. A metadata repository has been developed to capture the metadata from this and all relevant systems to be integrated through the data warehouse. The Pediatric Oncology Management System has been created to manage research subjects' treatment while collecting data on and providing decision support regarding protocol treatment administered, related toxicities, and outcomes.

Specific Aim 2: Extend integrated information resources beyond the walls of City of Hope.

2.1 Create a CRIIS Knowledge Net to provide seamless access to databases and systems campus-wide. The concept of the CRIIS Knowledge Net is to integrate access to all major applications on campus through a single interface that will become the standard desktop configuration at City of Hope. We have continued to incorporate new Internet-based research, patient care, education, and administrative systems as they have been developed.

2.2 Provide remote access to knowledge-based resources from any workstation and via the Internet for faculty, staff, volunteers, patients and their caregivers. As highlights of several systems, the Clinical Trials On-Linesm system delivers summary protocol information on treatment options to the public via the Internet, and serves as a centralized secure repository of protocol documents for over 240 ongoing protocols accessed by the COH research team. The NCCN Internet-based Data System collects patterns of care and outcomes data on all patients with selected cancer types. The Graphical Decision Support Interface is being piloted in the community oncology setting to provide automated decision support for guidelines of care via the Internet, and to collect data on patients' presenting characteristics and treatment decisions.

From the administrative aspect, the Data Analysis & Management Operating Procedures Site (DAM-OPS) was developed to provide standard operation procedures, case report forms, program documentation and other tools required to support the Division's staff in supporting research. The Virtual Account Manager (VAM) was developed by the ITS Department to allow internal departmental budget information to be merged with grant budgets for tracking and forecasting research overall expenditures. The Sponsored Trials Account System (STAS) was designed by Sponsor Research to track the budgeting and collections of funding for clinical trials. The Division of Information Sciences has assisted with integration of data from BITS and other systems to provide patient accrual and forms completion information, as milestones triggering the collection of payments from sponsors.

The following table outlines the status of new and continuing Internet-based projects developed under CRIIS:

2.3 Make available shared high-end computing tools for scientists and graduate students. The Biomedical Informatics Core Laboratory provides state-of-the-art large-scale computational support of at least 200 COH researchers for central data storage and end-user data mining tools. Computer assisted molecular modeling resources are being provided. Collaboration in computer assisted molecular design and data mining from our databases for therapeutic agents is ongoing with scientists at COH, University of California in Riverside, and University of Southern California. An alliance with UC Riverside signed in May 2002 will provide access to increased and enhanced computing and library resources for faculty and students on both campuses.

A new Biomedical Informatics core was recently approved as part of COH's Cancer Center Support Grant as a NCI-funded Comprehensive Cancer Center, one of only 5-6 approved to date in the nation under this granting mechanism. In October 2003, the fourth "Workshop on GenBank and NCBI Resources" was hosted by City of Hope. The third advanced NCBI program was also offered in October of 2003. The Accelrys (formerly GCG) Wisconsin Package for biosequence analysis is being supported by Systems Biology and is now regularly used by approximately 250 City of Hope investigators. In January 2003 an 8 processor Silicon Graphics server was acquired to replace the dual-processor Sun server formerly in place.

Specific Aim 3: Continue to support the necessary human, information, and technology resources required to achieve our information integration goals.

3.1 Create and sustain the appropriate organizational leadership and structure to guide the information integration efforts at City of Hope. The committees guiding the IAIMS initiative continue to meet regularly as originally intended. The new Library Director, hired in September 2001, has a joint appointment as Information Scientist. This position acted at Interim Curriculum Director of the FIRST project during 2002, leading to the successful recruitment of Dr. Hemant Shah to this position.

3.2 Provide training and educational opportunities to staff, patients, students, interns, and an IAIMS assistant conducting an apprenticeship at City of Hope. In January 2003 Hemant Shah, an MD with postgraduate informatics training, was hired as IAIMS assistant. Undergraduate student interns continue to work on IAIMS-related projects. Training is ongoing for staff members within the Division of Information Sciences. The Informatics Laboratory staff continue to organize software training for beginning GeneSpring, Accelrys, advanced GeneSpring and NCBI (see section 2.3 above).

In August 2002, a three-day "GCRC Biomedical Informatics Training Program" funded be FIRST, was held at City of Hope. GCRC investigators and staff from City of Hope and centers around the United States attended, as well as the Director of the Clinical Research Branch of the NCCR and three researchers from Germany. The program was designed according to survey feedback from earlier GCRC meetings, and was intended to assist GCRC staff in understanding the basics of bioinformatics, and how programs could be developed at their institutions. In October 2003, “Information Integration: the Next Frontier,” a GCRC Biomedical Informatics workshop was sponsored by COH on the NIH campus with almost 100 individuals in attendance. 

COH ID badges now provide access to the Graff Library 24 hours a day, seven days a week, with Internet access, printing and photocopying capability available at all times.  The Ovid search interface to medical and scientific databases and journals was installed in the library.  Training and documentation have been provided campus-wide. 

3.3 Conduct evaluations of both planning and implementation processes and outcomes. The AAMC-GIR/IAIMS Site Visit in March 2002 provided an excellent opportunity for personnel from other IAIMS sites to investigate and comment on City of Hope's program. Regular meetings of the FIRST Steering Committee evaluate that program. Structured evaluation forms were used at the GCRC Bioinformatics Training Program in August 2002. Dr. Joan Ash continues as external consultant and will survey the IAIMS initiative in 2004.

3.4 Ensure high-level security in accordance with recent recommendations and appropriate to the magnitude of risk. City of Hope's enhanced data security system was demonstrated by ITS (Information Technology Services) staff at the IAIMS Site Visit in March 2002. A sub-group of the Information Security Steering Committee meets weekly, and includes our CIO, Data Security Administrator, Director of Biomedical Informatics, and Director of the Research Computing Support Core. New information security policies and procedures have been implemented, including the appointment of data stewards for all information resources.

Dr. Joyce C. Niland, PI, and Dr. Douglas C. Stahl, Co-Investigator, have become involved in national initiatives through our IAIMS efforts to help build and standardize information infrastructure for cancer research.  Dr. Niland and Dr. Stahl chair AACI subcommittees to provide recommendations to the NCI on data representation and exchange standards for our nation’s cancer centers.  Dr. Niland also served as the Chair of the IAIMS consortium, Chair of the Clinical Trials Working Group of the American Medical Informatics Association (AMIA) and Chair of the NLM BLIRC Review Committee.  She continues as an IAIMS consultant for Loyola University.  She presented on AACI Informatics Initiative at the AACID National meeting in Chicago in September 2002.

Summary

The IAIMS initiative at COH continues to expand its programs, personnel, and resources being made available to the clinical and research communities in pursuit of integrated information across the COH enterprise and beyond.  During the last year of our implementation grant, our efforts in metadata analysis and data warehousing will continue.  We will continue work on the Clinical Research Data Model and applications of the FIRST project, the GCRC informatics training program, and the AACI national informatics initiative.  A Graff Foundation grant will provide turnkey software for an Integrated Library System in Graff Library, replacing the existing online catalog and serials check-in system.  Remote access circulation will be available on campus and through the VPN.  We have been granted funding from NCRR to be the National Islet Cell Consortium Coordinating Center to provide the informatics resources required to create and maintain the consolidated central database, using innovative leading technology and security/confidentiality practices.  We plan to acquire more comprehensive biomolecular databases, hold additional informatics training programs to increase the awareness and use of the Bioinformatics Core resources.  We expect to respond to increased demands for proteomics, functional genomics, imaging, medical informatics and other new research directions with increased informatics support.