August 4, 2008
IN THIS ISSUE… NEWS AND EVENTS: ANNOUNCEMENTS: FEATURES: ARTICLES: GENERAL INFORMATION:
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. (University of Rochester). 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), Case Western Reserve University, for more information. Consortium Oversight Committee Face-to-Face Meeting The CTSA Consortium Oversight Committee is convening a face-to-face meeting October 6–7, 2008, in Bethesda, Md. Anthony Hayward, NCRR, is the NIH coordinator for this committee. Administration Workgroup Face-to-Face Meeting The CTSA Administration Workgroup is convening a face-to-face meeting October 7–8, 2008, in Bethesda, Md. Kameha Kidd, Iris Obrams, and Elaine Collier, NCRR, are the NIH coordinators for this workgroup. Informatics Steering Committee Face-to-Face Meetings The CTSA Informatics Steering Committee is convening a series of face-to-face meetings in Bethesda, Md. Elaine Collier, NCRR, is the NIH coordinator for this committee. October 15: Orientation Meeting for 2008 CTSA Informatics Steering Committee members Community Engagement Steering Committee Face-to-Face Meeting The CTSA Community Engagement Steering Committee is convening a face-to-face meeting October 24, 2008, in Bethesda, Md. Donna Jo McCloskey, NCRR, and Betty Tai, NIDA, are the NIH coordinators for this committee. Evaluation Steering Committee Face-to-Face Meeting The CTSA Evaluation Steering Committee is convening a face-to-face meeting November 8–9, 2008, in Denver, Colo., in association with the American Evaluation Association Conference. Lori Mulligan, NCRR, is the NIH coordinator for this committee. Biostatistics/Epidemiology/Research Design Workgroup Face-to-Face Meeting The CTSA Biostatistics/Epidemiology/Research Design Workgroup is convening a face-to-face meeting November 21, 2008, in Bethesda, Md. Iris Obrams, NCRR, is the NIH coordinator for this workgroup. 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 Sylvia Parsons.
New—Building Connections Page on CTSAweb.org A new page, Building Connections, has just been launched on CTSAweb.org and may be accessed through the Quick Links box. This purpose of this page is to begin to provide information that can help the CTSAs better connect and work together within and outside of the consortium. The new page features the following:
New—Featured CTSA Institution Page on CTSAweb.org A new section of the CTSA e-Newsletter, Featured CTSA Institution, is now posted on CTSAweb.org and can be accessed from the home page and the Participating Institutions page. 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 Opportunity Announcements NIMH has posted three funding opportunities for dissemination and implementation strategies to improve the uptake of evidence-based practices: NCRR to Host Demonstration for the CTSA Wiki and CTSAweb.org In response to demand, NCRR is offering one more online demonstration of the CTSA Web systems, CTSAweb.org, and the CTSA Wiki. Additional demonstrations have not been scheduled at this time but will likely be offered in the winter. Learn where key information is, how to navigate the sites, and basic editing in the Wiki. Next CTSA Web Systems Demonstration: 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 Participants To simplify enrolling and managing the rosters for 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."
University of Pittsburgh’s Clinical and Translational Science Institute
As part of its comprehensive education program, CTSI seeks to strengthen the pipeline of clinical and translational scientists. For instance, CTSI recently organized an educational outreach event in partnership with NCRR’s Science Education Partnership Award (SEPA) program. At a daylong program in observance of National DNA Day, CTSI promoted biomedical research to 120 students from 12 local middle schools using two mobile laboratories from Boston University and Carnegie Mellon University. CTSI has since purchased its own mobile laboratory for several local, SEPA-funded programs to provide science and research education to students, teachers, and the public across western Pennsylvania and West Virginia. CTSI supports clinical and translational scientists through its research facilitators—individuals familiar with all available research resources on campus who can advise investigators on how to access tools and services. CTSI makes it easy for investigators to draw on experts in informatics, statistical analysis, and regulatory requirements, among other topics, by providing a single point-of-service approach to investigators throughout the University’s six health sciences schools and the University of Pittsburgh Medical Center (UPMC). CTSI is also developing an online research community to facilitate research and collaboration by linking investigators across the geographically dispersed campus. CTSI is working with UPMC to bolster participation in clinical trials by developing an institutional registry of potential clinical trial participants. Through the UPMC electronic health record, the registry matches patients who express interest in taking part in clinical studies with a list of current trials being conducted through the university. The CTSI registry leverages not only UPMC’s reach (nearly 4 million outpatient visits and more than 167,000 hospitalizations a year) but also its investment of more than $500 million in an interoperable electronic health record system. To raise awareness about these and other programs, Pitt is undertaking a comprehensive communication campaign to spur researchers and other faculty to contact CTSI. The effort includes the upcoming launch of a revamped Web site with separate pages for researchers and the public. All of the communications efforts reflect CTSI’s commitment to helping individual investigators take advantage of Pitt’s resources with straightforward slogans such as “What can CTSI do for you and your research?”Regulatory Knowledge Workgroup—Part 2 The CTSA Regulatory Knowledge Workgroup promotes the protection of human subjects and facilitates communicating shared regulatory compliance issues and improvements. Co-chairs Tesheia Johnson, M.B.A., M.H.S., of Yale University, and Michael Joyner, M.D., of the Mayo Clinic, oversee a number of taskforces developed to address the workgroup’s broad focus. The Research Subject Advocacy Taskforce was charged with defining the mission, scope, and model for research advocacy within the CTSA consortium. In April, the Consortium Oversight Committee approved the following best practices recommended by the taskforce:
The Clinical Trial/Study Registration Tracking Taskforce was formed to examine various CTSA institutional approaches to address the new requirement to register clinical studies on ClinicalTrials.gov:
The Research Coordinator Taskforce was charged with defining and developing the mission, scope, and model for the role of clinical research coordinators (CRCs) within CTSA institutions. The taskforce defined the following objectives:
In addition, it distributed a CRC survey to collect information on CRCs’ responsibilities, workload, and attitudes toward the role of CRCs. The Alternative IRB Model Pilots Taskforce, which was charged with identifying useful alternative IRB models and proposing models relevant to the CTSA Consortium Oversight Committee (CCOC), provided an update at the CCOC meeting in November 2007. The taskforce discussed the outcomes from its August 2007 meeting, CTSA challenges and opportunities, a charge issued by the Secretary’s Advisory Committee on Human Research Protections (SACHRP), and the provisions and outcomes of the SACHRP CTSA panel. The Clinical Research Management Taskforce convened a two-day meeting in June to address developing metrics to facilitate performance measurement (for details, see Regulatory Knowledge Workgroup—Part One in the July issue ). The Investigational New Drug (IND) / Investigational Device Exemption (IDE) Taskforce is making progress in conducting a survey to help define how each CTSA institution has implemented its IND/IDE support systems. The Centers for Medicare and Medicaid Services Regulations Impact Taskforce will facilitate understanding of changing regulations.
West Coast Consortium: Taking Steps Forward with 2nd Meeting The CTSA West Coast Consortium held its second meeting on June 25, 2008, on the campus of the University of California, Davis (UC Davis), Medical Center. Overall, 58 representatives from eight institutions with six CTSA-supported sites (Oregon, UC Davis, UC San Francisco, University of Washington, Scripps Research Institute, and Stanford University) attended. Following an update on the June workshop organized by the CTSA Clinical Research Management Taskforce, Enhancing Clinical Investigation by Improved Management (see July issue for details), participants identified some areas for potential regional collaboration. The West Coast Consortium could:
In a breakout session on public-private partnership, participants decided to identify educational materials/methods to build expertise in commercialization that could be shared among western CTSA sites. They will also look for opportunities to organize or promote regional educational forums. These efforts will concentrate on two somewhat distinct audiences interested in biomedical commercialization: those in career development tracks and faculty investigators. In the same breakout session, a participant volunteered to draft a list of core resources that are essential for drug development. The list will be circulated among the western CTSA institutions to aid their core cataloging efforts. The group also agreed to plan a follow-up meeting of unique core directors to discuss collaborative capabilities. Participants in a breakout session on tools for social networking and collaboration agreed that an important next step for moving forward with a social network as a shared resource is to develop a list of key data elements for social network analysis that would facilitate cross-institutional comparisons. The group will also follow the progress and deployment of the Oregon Clinical and Translational Research Institute tool for networking, which was demonstrated at the meeting. A breakout session on National Primate Research Center (NPRC)/CTSA partnerships identified two key steps: 1) build on resources for investigators (e.g., a resource database, the West Coast Consortium Web site), and 2) match and leverage pilot program funds (planning grants for targeted opportunities that include trainees). The participants also considered education a priority, noting the need to co-mentor graduate students and fellows in CTSA training programs and to train students, fellows, and visiting scientists in conducting nonhuman primate research. To achieve these goals, participants proposed a working group that would include the three West Coast NPRC directors and translational leadership at the West Coast CTSA sites. The group will draft a plan and timeline for developing the West Coast Consortium Web site and draft a request for applications for targeted pilot and collaborative studies that include investigators at more than one NPRC/CTSA site as well as trainees. The West Coast Consortium hopes to hold a third meeting later this year. Putting a CTSA Strategic Plan into Operation At its April 2008 meeting, the CTSA Consortium Oversight Committee (CCOC) identified the need for strategic planning and agreed to hold a retreat to initiate the process. As a result, the CTSA Consortium Operations Group met in Pittsburgh in July to draft top strategic objectives of the CTSA program in preparation for the October meeting of the CCOC. Steven Reis, M.D., principal investigator of the University of Pittsburgh’s CTSA, invited Peter Johnson, M.D., from Scintellix to lead the group through the Hoshin Strategic Planning Approach, which was used successfully by the University of Pittsburgh CTSA. This process involves stratifying “raw” strategic concepts by dominance (for example, by pair-wise comparison), then normalizing them relative to present progress to identify priorities. The CTSA consortium will apply the process to each of its top priorities to identify the most critical implementation steps. The report of the retreat, which has been distributed to all the CTSA institutions and the CTSA Consortium Steering Committees, describes how the strategic plan will be written to include not only the overarching priorities required to achieve the mission but also the tactical steps needed to guide day-by-day progress. Taking progress to date into consideration, robust data sharing networks were identified as an important initial strategic objective that would have a strong influence on other high-priority outcomes. The next step will be to compile responses to the meeting report from the different CTSA communities and determine how CTSA committees and workgroups will implement the tactical steps. CTSA Consortium Operations Group teleconferences in August and September will allocate time for reviewing what the Steering Committees have accomplished to date.
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—The CTSA Web systems have a new help desk e-mail, help@CTSAweb.org. Please contact the help desk if you have questions regarding the CTSA systems, including CTSA Wiki and password questions. Read archived CTSA e-Newsletters on the CTSAweb.org CTSAs in the News page.
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The University of Pittsburgh’s Clinical and Translational Science Institute (CTSI) is taking a comprehensive approach to fostering multidisciplinary research, coordinating services for its researchers, and facilitating patient and community participation in research studies—in some cases reaching beyond the confines of the campus to enhance effective partnerships. For example, under the auspices of CTSI, a team of researchers from Intel and Carnegie Mellon University joined those from Pitt to evaluate how novel software could enhance the diagnosis of common diseases using radiologic imaging. This collaborative initiative, known as the Diamond Program, led to the first medical application of an interactive, search-assisted diagnostic system to detect breast cancer based on mammograms. This system enables radiologists to rapidly compare a suspicious mammogram finding to a large reference collection of annotated cases of benign and malignant lesions. Ultimately, Diamond is expected to improve the accuracy of mammography and demonstrate the application of a novel, open-source technology platform to enhance diagnosis based on imaging. 