Research Education, Training and Career Development
The MS in Clinical and Translational Research now has 54 students. A Certificate in Clinical and Translational Research program, launched in 2009, is a 14-credit hour program to train fellows and junior faculty primarily interested in serving as collaborators rather than as principal investigators on clinical and translational research projects. Fifty-five students have enrolled and 17 have graduated. With an ARRA supplement, we implemented an on-line version of the Certificate program A second ARRA supplement is creating an online curriculum in Clinical Research Informatics. Our third KL2 RFA attracted 15 applications for 2 slots. Four Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) K12 Scholars appointed in 2010 completed their first year. The CCTST has supported new and competitive renewal applications for T32s and K12s and has developed a K Club designed to support career development for young investigators. The K Club has held monthly meetings covering topics requested by its members. The CCTST Grand Rounds series has been quite successful with now monthly (formerly quarterly) presentations by outstanding local and national experts in topics relevant to clinical and translational research.
Participant and Clinical Interactions Resources (PCIR)
The two sites for the Clinical Translational Research Center (CTRC) at CCHMC and the VA Medical Center continue to have robust utilization with increased complexity of visits at each site. The UC Clinical Trials Office has been reorganized under UC Physicians with current direction shared with the CCHMC Clinical Trials Office and a direct relationship for both with the CCTST. Considerable efforts have been directed toward recruitment and retention of research subjects at UC and CCHMC. A CCTST-supported recruitment specialist has been expanding services to UC with considerable success. We have actively participated in ResearchMatch and have staff supporting retention efforts for studies by using Accurint®, a commercial product designed to find “lost” research participants.
Regulatory Knowledge and Support
UC and its AHC have two separate Offices of Research Compliance and Regulatory Affairs (ORCRA) in which the IRBs for UC and CCHMC reside. There has been increasing integration of these programs through an AHC IRB Advisory Committee, a Research Cabinet formed by the Senior Associate Dean for Research, and an AHC ORCRA Advisory Committee. To better harmonize IRB activities across the AHC, Click Commerce®, which is already in use at CCHMC, will be installed at UC during the first quarter of 2012. Work is continuing with the 17 hospitals in the Greater Cincinnati metropolitan area to identify and remediate obstacles to multisite research within our community. Much of the preliminary ground work has been completed during 2010-11, beginning with an agreement to develop uniform informed consent forms. During the last year, the CCTST has sponsored cross-campus town hall meetings for education and debate related to biobanking, responsible authorship, and ethical exceptions and expectations related to informed consent.
Community Engagement and Research
The 32-member Community Partner Council, which has met quarterly, has provided input directed at ensuring bidirectional relationships between the community and the AHC, including a community perspective regarding consent for specimen collection in the biobanking initiative developed at CCHMC. Within the practice-based research networks, 17 family medicine practices have been added to the Cincinnati Lifespan Practice Research Consortium and 18 pediatric practices have been added to the Cincinnati Pediatric Research Group. We awarded 7 Community Health Grants totaling $93,000 in areas of obesity; infant mortality, including prevention and prenatal care; and mental health. The second class of 15 graduated from our Community Leaders Institute (CLI), a 6-week course to develop leaders in community research and community-based participatory research (CBPR). The first 2 classes have succeeded in obtaining $2.5 million in grants for their community-based organizations utilizing skills obtained from the CLI. The CLI is becoming a national model; the UCLA and UK CTSAs are planning to develop them. The Community Engagement Speaker Series featuring a number of prominent national leaders, and Community Engagement Roundtables have been quite successful.
Translational Technologies and Resources
The CCTST through the CTSA grant and institutional support provides limited resources for programs that may be integrated into T1 research efforts. During the last year, programs such as drug discovery, proteomics, imaging, cell and molecular therapy, and translational and molecular disease modeling have assisted a limited number of investigators with specific needs. As examples, the Molecular and Cell Therapy Matrix Program has expanded new technology to derive induced pluripotent stem cell (iPSC) lines from humans by using a multicistronic vector that can be removed from the genome after reprogramming. They have now generated more than 40 human iPSC cell lines and have obtained several additional grants for this technology. The Drug Discovery Center has increased the number of investigators and institutions that utilize its services. Concerted efforts have begun to foster interaction among the three Ohio CTSAs to leverage expertise in drug discovery at each of the institutions. The Proteomics Core has assisted investigators in biomarker profiling in new studies of idiopathic pulmonary fibrosis and Candida bloodstream infections. Translational and molecular disease modeling has developed a program called “ToppCluster,” which allows researchers to build state-of-the-art graph networks and models of normal and abnormal biological systems.
The Evaluation Core has become an integral part of everyday CCTST functions. The project evaluator, Jack Kues, PhD, attends weekly project administrative staff meetings, bi-weekly Steering Committee and TnT (T1/T2) meetings, and weekly meetings with the co-PIs. Two major Evaluation Core initiatives have continued into Year 3: 1) With support from the Biomedical Informatics Core, the Evaluation team is developing a comprehensive dashboard to collect data centrally from the various cores and to provide feedback to the cores and the public regarding progress toward the goals of the CCTST, and 2) there is a real interest in developing better collaborative efforts among faculty and trainees in the AHC, the West Campus, and the community. As such, efforts are being directed toward social networking. The CCTST has created a membership program that now numbers over 800 faculty and community members, and members will be able to search easily for collaborators with similar or complementary research interests. With the guidance of the Evaluation Core, the CCTST is also aggressively promoting use of eProfessional, a research networking program similar to VIVO and Harvard Profiles developed and implemented at UC several years ago but not yet realizing its full potential.