September 8, 2008
IN THIS ISSUE… NEWS AND EVENTS: ANNOUNCEMENTS: FEATURES: ARTICLES: GENERAL 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 Rockville, 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 Rockville, 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 Rockville, Md. Elaine Collier, NCRR, is the NIH coordinator for this committee. October 15: Orientation Meeting for 2008 CTSA Informatics Steering Committee membersOctober 16: CTSA Informatics “All-Hands Meeting” October 17: Data Repository Best Practices Symposium—organized by Data Repository Interest Group Clinical Research Ethics Workgroup Face-to-Face Meeting The CTSA Clinical Research Ethics Workgroup is convening a face-to-face meeting October 23, 2008, in Cleveland, Ohio, in association with the American Society for Bioethics and Humanities Annual Meeting. Dan Rosenblum, NCRR and Christine Grady, NCC are the NIH coordinators for this committee. 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 Rockville, 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 in association with the American Evaluation Association Conference. Lori Mulligan, NCRR, is the NIH coordinator for this committee. New York and Connecticut (NYCON) CTSA Consortium Retreat Columbia University will host the first NYCON CTSA Consortia Retreat on November 18 and 19, 2008. The retreat is an effort to encourage joint ventures and collaborations among six northeast CTSAs (five New York and one Connecticut), comprised of meetings with leaders from each NYCON CTSA, as well as sessions focused on science/training by and for our KL2 and TL1 scholars, and our master's students. 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 Rockville, Md. Iris Obrams, NCRR, is the NIH coordinator for this workgroup. Public Private Partnerships Steering Committee Face-to-Face Meeting The CTSA Public Private Partnerships Steering Committee is convening a face-to-face meeting December 15, 2008, in Bethesda, Md. Lili Portilla, NCRR, and Mark Scheideler, NINDS, are the NIH coordinators for this committee. Recent Media Coverage 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.
Duke Announces a Request for Proposals for Duke and Durham Investigators to Plan Innovative Approaches to Specific Health Issues in Durham County Rob Califf has frequently drawn our attention to statistics that suggest that the U.S. has room for improvements in commonly used end-points such as maternal and infant mortality. Now in an RFP directed towards Duke and Durham investigators, Drs. Rob Califf and Lloyd Michener invite applicants to identify a cause of death and/or disability of significance in Durham County, to research the causal factors and, in a target population of residents who are affected by the problem or are at risk, to develop a business plan for an alternative model of care/prevention to lower morbidity and mortality. The initiative is very much an embodiment of CTSA philosophy as it seeks to capitalize on healthcare advances that have already been modeled in the environments of academic health centers. Find out more about the “Grants to Plan Innovative Duke-Durham Partnered Approaches to Specific Health Problems in Durham County” RFP at http://forms.dukehealth.org/dccr/dtmi.nsf/rfp.Emory University Hosted a Conference on Ethics and Translational Research On May 15, 2008, Emory University’s Center for Ethics and Office of Clinical Trials co-sponsored a conference on “Ethics and Translational Research: From Discovery to Implementation.” Presentations included overviews of translational research, conflicts of interest, intellectual property, policymaking, ethics and regulation, anti-cancer drug development, research in vulnerable populations, and future directions. This conference was made possible by the Atlanta Clinical and Translational Science Institute. Streaming videos of the entire conference are available at: http://www.ethics.emory.edu/content/view/432/98.NHLBI Launches New Website on Children and Clinical Studies The National Heart, Lung, and Blood Institute (NHLBI) has launched a new website that serves as an educational tool about Children and Clinical Studies. The prospect of children participating in research often gives pause to parents and providers alike because the concepts and safeguards are poorly understood. This new web-based educational tool can help erase the confusion, allay the concerns, and empower parents and children with the information they need to understand clinical research and make informed decisions about participating in a study. It also provides sufficient content to educate trainees and junior faculty about key concepts in pediatric research. Geared to all educational levels, the site provides information and multimedia resources on:
Please visit the site at: www.ChildrenAndClinicalStudies.nhlbi.nih.gov. NIH Announces Public Conference on the Toolbox Initiative The National Institutes of Health (NIH) is hosting a conference — “Building the NIH Toolbox” on October 27, 2008. The Toolbox initiative, focused on the assessment of neurological and behavioral function, seeks to assemble brief, comprehensive assessment tools that will be useful to clinicians and researchers in a variety of settings, with a particular emphasis on measuring outcomes in longitudinal epidemiologic studies and prevention or intervention trials across the lifespan. The Toolbox will ensure that assessment methods will be capable of comparison with existing and completed studies. In this inaugural conference discussion will include:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Funding Opportunity Announcement NIAAA has posted a funding opportunity on the Epigenomics of Human Health and Disease: RFA-RM-08-017. The RFA is focused on identifying global epigenome-wide marks or features that characterize diseased, aged, or environmentally compromised human cells or tissues. 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 Posts Recording of Web Demonstration for the CTSA Wiki and CTSAweb.org NCRR hosted a pilot series of online demonstrations of the CTSA Web systems, CTSAweb.org, and the CTSA Wiki. The series was very successful, and NCRR anticipates hosting another series in the winter. For those that could not participate, a recording of the most recent session presented on August 6, 2008, is available at: https://webmeeting.nih.gov/p79124490. PowerPoint versions of the tutorials for each system and the link to the recording are available on the CTSA wiki in CTSA Main, under the Important User Information section.Building Connections Page on CTSAweb.org A new page, Building Connections, has 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.
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.
Columbia University’s Irving Institute for Clinical and Translational Research
The Irving Institute initiated the novel Collaborative and Multidisciplinary Pilot Research (CaMPR) award program to further encourage the establishment of new, multidisciplinary research teams. The institute first awarded four six-month planning grants to help multi-school teams of investigators develop applications for pilot research project awards. It then selected the top two teams and provided them with additional support to gather pilot data for submission of applications for external funding. The Irving Institute will offer a second round of CaMPR awards this year. Staff will evaluate the outcomes of the program to determine whether it is achieving the goal of fostering transformative research. The Irving Institute is also building translational research into its existing infrastructure. Without the restrictions of the general clinical research center model, the Irving Institute’s Clinical Research Center has been able to place research nurses and coordinators in the medical center’s key adult and pediatric medical and surgical intensive care units, emergency departments, and the coronary care unit. This strategy dramatically increased the number of research protocols proposed and is expected to significantly elevate the quality of research performed. Recently, unit leaders decided to develop a joint research project in which data collected across all units from continuous EEG monitoring of critically ill patients with reduced mental status will be examined for information that might form the basis of future research projects. TRANSFORM (TRaining And Nurturing Scientists FOr Research that is Multidisciplinary) houses the Irving Institute’s educational programs, which include a master’s degree, predoctoral certificate, and the K12 mentoring and training program for clinical researchers. TRANSFORM recently initiated a “K-to-R” seminar series that provides mentoring, individual assistance, and a formal didactic program for K awardees at CUMC who are planning to write their first R01 or similar application. Awardees will build their applications, section by section, with peer and mentor feedback. The Irving Institute recently received an additional $2 million toward the construction of a TRANSFORM educational center from its long-time benefactors, Herbert and Florence Irving. With support from the National Clinical Research Associates supplemental grant from NCRR, the Irving Institute’s Community Engagement Resource partnered with its Biomedical Informatics Resource to begin conducting surveys, interviews, and focus groups in the surrounding community, to identify incentives and barriers to clinical research perceived by community leaders, non-academic health care providers, and patients. A new offsite community center—located in an area where many community physicians maintain private offices—will facilitate these efforts and increase community-based research while also nurturing relationships within the neighborhood. Finally, the Irving Institute will support the exchange of information and resources across CTSA sites with a New York/Connecticut regional CTSA symposium to be held on the Columbia University campus November 18–19, 2008.Pediatrics Oversight Committee Energized by New Members, Organizes New Workgroups At its June 23–24 meeting, the Pediatrics Oversight Committee (POC), charged with addressing the unique challenges pediatrics researchers at CTSA institutions face, established its own operations group and four new workgroups. The meeting also spurred a new professional alliance. The POC’s initiatives stemmed from a surge in resources and momentum as 14 new CTSA sites joined the consortium, at least nine of which have pediatric hospitals. These institutions bring with them well-established pediatric research networks as well as the clinical and regulatory expertise of their existing pediatric General Clinical Research Centers. The newly formed, 11-member Operations Group will help implement the priorities of the POC and facilitate communication with other CTSA steering committees and clinical integration workgroups. Members include the POC chair and chair-elect, the principal investigator liaisons, three NIH representatives, and four members elected at large. Four new workgroups also have been established and will address needs identified during the June meeting. The Pediatric–Adult Lifespan Research Workgroup will focus on cross-disciplinary collaboration between pediatric and adult medicine as a means to success in clinical research, while the Pediatric T2 Research Workgroup will work to expand child health research into the community and clinical practice environments. Through its efforts to identify multicenter pediatric clinical research networks shared among the 38 CTSA sites, the Clinical Research Networks Workgroup will augment research capacity across the consortium. The Metrics of Success Workgroup will determine how to measure, track, and evaluate the impact of these changes over time. The POC’s three existing workgroups have been energized by the influx of new members. The Drugs and Devices Workgroup participated in the U.S. Department of Health and Human Services’ Pediatric Medical Devices Stakeholders Meeting on July 23, 2008. The workgroup will hold a follow-up meeting December 11–12 at Natcher Auditorium on the NIH campus to enhance pediatric drug and medical device development. The Rare Diseases Workgroup will collaborate with the CTSA Biobank Consortium to improve sample coordination, management, sharing, and awareness of sample availability across the consortium, facilitating collaboration in clinical research. Other workgroup projects include institutional review board (IRB) review templates with boilerplate language to increase enrollment in clinical trials for rapidly fatal congenital conditions. The workgroup is also evaluating a Web-based, parent-initiated enrollment tool for possible use across CTSA sites. The Pediatric Research Ethics Consultation Group merged with the POC Infants and Children in Research Workgroup to become the Pediatric Research Ethics Workgroup. The group focuses on inconsistencies in IRB policies and procedures in multicenter studies and is planning a webinar about issues related to adolescent research subjects. Finally, the POC established a formal alliance with the Pediatric Academic Societies (PAS) and will hold its annual meeting jointly with the PAS this spring in Baltimore. The POC will meet April 30–May 1, 2009, followed by the PAS annual meeting May 2–5. The PAS meeting will include a two-hour platform session featuring the top eight pediatric clinical and translational research abstracts from CTSA sites. Thanks to this alliance, the PAS will provide meeting space for the POC’s face-to-face meeting free of charge.
NIH Clinical Center’s Bench-to-Bedside Program
Extramural principal investigators (PIs) with an existing NIH grant (e.g., researchers at CTSA sites) are invited to initiate proposals by seeking an intramural partner at NIH who would function as the project leader and serve as the point of contact. To identify an intramural collaborator, extramural investigators can consult the NIH’s database of all current intramural research at http://intramural.nih.gov/search/index.tml. Intramural investigators in all NIH institutes and centers are eligible to serve as project leaders on proposals. Research proposals can fall into one of seven categories, each of which is associated with an NIH sponsor (with one exception, the general category): pharmacogenomics, behavioral and social sciences, rare diseases, AIDS, minority health and health disparities, women’s health, and general projects. Pharmacogenomics, a new category for 2009, is sponsored by the Food and Drug Administration (FDA). The Bench-to-Bedside program’s new electronic venue will aid investigators in submitting a letter of intent and in collaborating online with the project leader on developing a proposal for submission. Reviewers will also have access to online features to augment the review process. For awards involving extramural partners, extramural funds will be directed as an administrative supplement to an existing grant. If indicated, the amount of funds to extramural investigators may be increased to cover indirect costs. Among other stipulations, the grant vehicle must be capable of receiving administrative supplements for two years and the support must be consistent with the approved aims and objectives of the grant. Principal investigators for all awarded projects will be required to submit annual progress reports on the project’s status. For the 2009 awards, a letter of intent must be submitted by October 10, 2008. Additional information is available on the Bench-to-Bedside program website at http://www.cc.nih.gov/ccc/btb/awards.shtml.Regional Workshop Series to Follow Success of May 9, Community Engagement Workshop Soon after the success of the May 9, 2008 National Workshop entitled “Accelerating the Dissemination and Translation of Clinical Research into Practice”, the CTSA Community Engagement Steering Committee (CESC) has planned 5 regional workshops to be held throughout the United States. Each of the currently funded 38 CTSA site representatives from the CESC have contributed to the planning of these 5 workshops. The goals for the workshops are to support and strengthen community engagement in the CTSA program, facilitate partnerships between CTSAs and community organizations and health institutions, to promote community partnerships as an essential component of translation of research to the community, and of community concerns to researchers. Objectives for each workshop include
Information on the upcoming Regional Workshops: Southeast Region: September 5, 2008 Midwest Region: September 12, 2008 Northeast Region: September 25, 2008 Eastern Region: October 13, 2008 West Region: October 17, 2008
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 Irving Institute for Clinical and Translational Research of Columbia University Medical Center (CUMC) focuses on fostering collaboration across schools and disciplines. For example, the Institute’s interactive informatics system, WorkWeb, will apply the principles of online social networking to enable investigators throughout Columbia University to identify others working on similar or related research and thus spark innovative, multidisciplinary collaborations. WorkWeb will bring together information from investigators, institutional human resources data, and such databases as PubMed and CRISP. Using wiki technology, it will facilitate communication and access to resources while enabling the Irving Institute to track both resource use and outcomes. 
The NIH Bench-to-Bedside program, originally established in 1999 to integrate the work of basic and clinical intramural scientists and since 2006 open to partnerships between intramural and extramural programs, is expanding again. (Intramural science refers to research that takes place on an NIH campus under the auspices of federal employees, while extramural research is conducted by investigators and institutions outside of NIH.) Beginning in fiscal year 2009, CTSA and NIH investigators will be able to initiate applications jointly for Bench-to-Bedside research projects. 
