July 7, 2008
NEW—Monthly Featured CTSA Institution IN THIS ISSUE… NEWS AND EVENTS: ANNOUNCEMENTS: FEATURES: ARTICLE: GENERAL INFORMATION:
Mayo Clinic Research on Wheels To increase community engagement in research studies, the Mayo Clinic Center for Translational Science Activities (CTSA) has added a Mobile Research Unit vehicle to its resources. Beginning in July, Mayo researchers will use the vehicle throughout southeastern Minnesota for clinical research projects. Indiana University Convenes Retreat to Inform Faculty of New CTSI Services The new Indiana University Clinical and Translational Sciences Institute will hold a day-long retreat in July to inform faculty of services and collaborators available on campus related to the creation of the Indiana CTSI, to facilitate interactions between clinical and basic science researchers and inform the CTSI leadership of the needs of investigators. It is anticipated that this retreat will help address the question of "How will the creation of the Indiana Clinical and Translational Sciences Institute actually affect how Indiana University School of Medicine researchers do their work?" CTSA Consortium Oversight Committee Operations Group to Hold Retreat The CTSA Consortium Oversight Committee (CCOC) Operations Group is holding a Strategic Planning Pre-Meeting retreat in Pittsburgh, PA on July 8th. Objectives for the retreat are to: 1) identify and triage the top strategic priorities for the CTSA consortium to enable a focused discussion for the full CTSA strategic planning retreat in October 2008 and 2) clarify the implementation approach to the elements of the strategic plan (including CTSA governance) in preparation for the strategic planning process. Northwestern University Hosts Onco-Biotechnology Summit Northwestern University will hold a summit, July 24–25, that will focus on present and future biotechnology-relevant cancer diagnostics and therapeutics. The goal is to create a cross-discipline dialogue on critical current and emerging challenges and opportunities in developing novel personalized therapeutics and diagnostics, and adopting them in clinical practice and reimbursement. The program will include presentations and panels about important research and clinical challenges in specific disease areas, perspectives on research fields (such as cancer stem cell research and nanotechnology), as well as dialogues on patient adherence and safety, payer perspectives and investment partnerships—in the context of the present and future state of biotechnology. For more information and to register, please visit: http://www.cancer.northwestern.edu/oncobiotech/index.cfm Case Western and Rochester Host Social Network Analysis Summer Institute Case Western Reserve University and the University of Rochester are hosting a social network analysis workshop on August 7–8 in Cleveland, Ohio. The Social Network Analysis Summer Institute will be a "hands-on" workshop led by Stephen Lurie, M.D., Ph.D. The workshop is designed for researchers and evaluators who are interested in learning the concepts and methods of social network analysis, particularly as it applies to program evaluation. Contact Patricia A. Higgins, R.N., Ph.D. (patricia.higgins@case.edu) for more information. Informatics Steering Committee Face-to-Face Meetings The CTSA Informatics Steering Committee is convening a series of face-to-face meetings in Bethesda, MD. October 15: Orientation Meeting for 2008 CTSA Informatics members Read CTSA institutional and consortium news and media coverage at the CTSAs in the News page on CTSAweb.org. We want to post your CTSA institutional news items and open events in the CTSA e-Newsletter and on the CTSAweb.org Events page. Please send submissions to Kameha Kidd, kiddka@mail.nih.gov.
New—Monthly Featured CTSA Institution A new section—Featured CTSA Institution—has been added to the CTSA e-Newsletter and will also be posted on the Participating Institutions page of CTSAweb.org. The purpose of featuring a CTSA institution on a monthly basis is to facilitate sharing and dissemination of the various features and successes of the CTSA institutions. Of particular interest are best practices that could be "portable" to other institutions, and resources that are available to researchers or institutions. National Institute of Mental Health (NIMH) Funding Opportunities NIMH has posted three funding opportunities for dissemination and implementation strategies to improve the uptake of evidence-based practices: http://grants.nih.gov/grants/guide/pa-files/PAR-07-086.html (R01) National Institute for Neurological Disorders and Stroke (NINDS)—Request for Information NINDS has issued a request for information soliciting input on current needs in emergency medicine research: http://grants.nih.gov/grants/guide/notice-files/NOT-NS-08-021.html. NCRR is Hosting Demonstrations of the CTSA Wiki and CTSAweb.org In response to demand, NCRR is offering two more online demonstrations of the CTSA web systems, CTSAweb.org and CTSA Wiki. Learn how to navigate key information and how to make basic edits to the Wiki. CTSA Web Systems Demonstrations: July 22, 3:00–4:00 p.m. ET August 6, 3:00–4:00 p.m. ET A recording of the June 24, 2008, demonstration is available for review at: https://webmeeting.nih.gov/p43967644/ NCRR Announces New System for Managing Committee Participation To simplify enrolling and managing the rosters of CTSA committee members and participants, NCRR is implementing a new web-based interface. Access to this system is through the CTSA Wiki and is restricted to CTSA PIs and administrators who have authority to assign representatives to committees. Guidelines are available on the Wiki—in CTSA Main under "Important User Information." New Helpdesk E-mail for CTSA Web Systems The CTSA web systems have a new helpdesk e-mail, help@CTSAweb.org. Please contact the helpdesk if you have questions regarding the CTSA systems, including CTSA Wiki and password questions.
Rockefeller University's Center for Clinical and Translational Science In its first 18 months, Rockefeller University's Center for Clinical and Translational Science (CCTS) has made substantial progress in many areas, including the support of clinical research, the initiation of novel translational science research, the development of teaching programs aimed at community physicians, the institution of Good Clinical Practice (GCP) for all research protocols, and the support of the national recognition and certification of clinical research nursing. Notably, two CCTS efforts may be models for the CTSA Consortium: (1) electronic programs that facilitate study tracking, scheduling, and reporting and (2) an Advisory Committee for Clinical and Translational Science (ACCTS) that expands on the roles of previous committees and serves as the primary protocol reviewer and governance structure for the CCTS. Review Board Assistant permits electronic production and distribution of protocols to both the ACCTS and the institutional review board (IRB) and creates the underlying board databases. Committee and board members review and sign documents electronically. Approximately 75% of the participants in Rockefeller's Outpatient Research Center studies were integrated into iRIS between September 2007 and March 2008, in a testing phase. Since then, investigators and reviewers have begun testing the iRIS system to submit protocols for ACCTS and IRB review. Once researchers and staff are fully trained in using iRIS and protocols have been managed in iRIS for a year, a large portion of the annual progress reports to the IRB will be automatically generated through iRIS's databases, including the number of screened, enrolled, and completed participants (including their ethnicities and racial statistics) and adverse events. This system will save time while it ensures consistency and accuracy. Regulatory Knowledge Workgroup—Part 1: Clinical Research Management Clinical research management, the processing of protocols and clinical studies, is a high-priority issue for the CTSA Consortium Oversight Committee (CCOC). To help generate action, the CCOC asked the CTSA Regulatory Knowledge Workgroup, which addresses trial processing and regulatory issues with the primary goal of keeping research participants safe, to develop a consortium taskforce that would encourage sites to improve processes, learn from each other, and develop evidence to document change. The taskforce, Clinical Research Management Taskforce, which included members of the CCOC as well as the chairs of the Regulatory Knowledge Workgroup, decided that a workshop on clinical research management would be a good place to start. In recent years, many academic sites, including several CTSAs, have begun process improvement by applying business models such as Lean Six Sigma that address interventions designed to improve quality and speed up processes. In doing so, they often use metrics and reassign tasks designed to improve protocols and scientific, contract, budget, and institutional review board (IRB) review. However, progress—even by the most successful centers—has been slow and often less than satisfactory. In planning the workshop, the taskforce concentrated on key elements that would provide useful tools to each CTSA site and effective means of introducing change, and posted reports and presentations on a public website (www.CTSAweb.org) in advance of the meeting. The workshop, entitled Enhancing Clinical Investigation by Improved Clinical Research Management, held June 23–24 in Bethesda, Maryland, aimed to support development of a system of metrics for measuring and promoting improved management of clinical research protocol processing. About 150 participants represented institutional leaders and key administrative staff from 37 of the 38 CTSA sites as well as 17 NIH institutes and centers and several national organizations. Brief presentations stimulated discussion. Roundtables allowed participants to share experiences. Participants identified encumbrances, such as highly complex processes, staff overload, ineffective electronic protocol processing systems, protocol-specific issues, insufficient training, and regulatory complexity. Communication failures and excessive numbers of procedural steps are severe, recurring issues that affect all aspects of the process. In poster presentations, each site shared its own metrics, methodology, and lessons learned. The participants reached general agreement on two key concepts: 1) A shared set of metrics could provide objective evidence of consortium-wide process improvement, and 2) CTSA sites may benefit by sharing tools for IRB and contracts processing. The group asked that two taskforces take responsibility for acting on these concepts. To provide focus and efficiency, the taskforces will be small. Membership will be open to all CTSA sites with selection based on skill sets and commitment. Access to non-members and transparency will be priorities. The CTSA will distribute taskforce membership information in July 2008. The CTSA Regulatory Workgroup plans another workshop for June 2009.
Upper Midwest Consortium Collaborates on Education Issues 
The Mayo Clinic hosted the 2008 Upper Midwest Consortium Annual Meeting on June 16–17, in Rochester, Minnesota. More than 70 scholars, faculty, and program leaders from eight institutions gathered to discuss opportunities for sharing research and mentoring resources for scholars, as well as possible areas of interinstitutional collaboration. The consortium includes representatives from regional CTSA and K12 institutions and from institutions in Institutional Development Award (IDeA) states. Its goal is to share resources and best practices and to facilitate collaboration on common issues. Dr. Anthony Hayward, director of the NCRR Division of Clinical Research Resources and the Clinical and Translational Science Award (CTSA) initiative, joined program leaders and administrators in two in-depth sessions on how to build, administer and fund this growing consortium. The group identified several areas for further consideration, including sharing curricula and online coursework and facilitating interinstitutional mentoring relationships. Scholars rotated from table to table during "speed networking" sessions with program leaders so everyone could have an opportunity to learn about resources, programs and mentors at each institution. It was one of the most popular events of the two-day conference, and it is already bearing fruit in new collaborations and mentoring relationships. The conference evaluations showed that attendees found their time together valuable. "I have made several contacts and corresponded with three scholars from other institutions since attending this meeting," wrote one participant. "I already have set up a meeting with someone I spoke with to discuss potential grant funding opportunities," another attendee commented. A third said, "The pharmacogenomics session was simply superb; both the plenary talk and workshops were great. Interest was generated for possible collaborations." "We really enjoyed hosting the Upper Midwest Consortium members this year," said Dr. Sherine Gabriel, co-principal investigator of the Mayo Clinic Center for Translational Science Activities (CTSA) and director of CTSA Education Resources. "We made some great progress on defining the structure and direction of the consortium, and we’re looking forward to working with our regional partners to strengthen clinical research education programs and career development opportunities for all our scholars."
Consortium Committee Meeting Calendar
* Please note that the meetings and events listed in this newsletter are provided for your information. If you wish to participate, please contact the NIH coordinator. Updated Information on CTSAweb.org CTSAweb.org was developed to ensure access to CTSA resources, enhance communication, and encourage sharing. The site continues to evolve with the CTSA in promoting this new direction of clinical and translational science. Features and updates:
Reminder—CTSAweb.org has undergone improvements that have resulted in URL changes. Please update your bookmarks. Read archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.
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