What's going to work? Teamwork!
CTSC Newsletter June 2013
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From the Directors
Ohio approves money for collaboration in medical research
ITEAC is a council within the Ohio Department of Development. The money will further Gov. John Kasich's Medical Corridor Initiative, which was announced in 2011. The collaboration began as Kasich's idea for statewide synergy among medical research institutions.
The Medical Corridor promotes Ohio's significant medical research assets and leverages them for job growth. The initiative supports collaboration among medical research institutions and the healthcare industry across Ohio's regions to help lower costs, improve patient care and increase the competitiveness of the state's biohealth industry. The Medical Corridor includes four main pillars: Choose Ohio, Ohio Clinical Trials Collaborative, Pediatrics, and the Medical Cloud Initiative.
Besides CWRU, other institutions in Ohio taking part include the Cleveland Clinic, University Hospitals Case Medical Center, MetroHealth Medical Center, Ohio State University, the University of Cincinnati, and the children's hospitals in Cincinnati and Columbus.
We want to build up Ohio as a medical research powerhouse and gain efficiencies in clinical research across the state. The themes fueling the collaborative are speed and efficiency. Funds will be used toward creating secure communication systems
among the eight institutions.
Gov. Kasich says the collaboration will increase the competitiveness of the state's biohealth industry, and "lead to unprecedented medical breakthroughs, attracting companies and innovators to Ohio."
Read the press release from the Governor's office.
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A Reliant Institutional Review Board (IRB) Review Process to Streamline the Conduct of Clinical Research
IRBs from eight legally separate institutions in Ohio [Case Western Reserve University (CWRU), the Cleveland Clinic (CC), MetroHealth Medical Center (MHMC), University Hospitals Case Medical Center (UHCMC), The Ohio State University, Nationwide Children's Hospital, Cincinnati Children's Hospital Medical Center and University of Cincinnati] developed a reliant review structure to streamline review and oversight of multi-center clinical research studies in order to increase efficiency of the review process and responsibly manage IRB workload.
The participating institutions are all Clinical & Translational Science Award (CTSA) sites and their IRBs engaged in reciprocal inter-institutional agreements built on the AAHRPP standards.
All human subject protection considerations are made by the IRB of record throughout the course of protocol review and management. The relying IRB(s) reviews for institutional resource utilization and requirements (i.e., data security, access to EMR, conflict of interest, etc.). If the relying IRB feels there needs to be modifications to the protocol or consent forms they must communicate such in writing to the investigators who will submit the modification to the IRB of record for review and approval.
The Cleveland CTSA supported construction of an electronic IRB hub, through which a protocol approved by one of the IRBs can be routed to any other IRB(s). The reliant review process promotes collaborative research projects, helps investigators begin important research studies faster, and helps provide answers to important scientific questions more quickly.
All of the IRBs would like to have any investigators who are thinking about utilizing Reliant Review come into to the office or call first as they may not need to complete the request forms themselves. Please contact:
MetroHealth:
Ginger Pomiecko Kathy Lawry
216.778.7741 216.778.2077
UH:
Karya Ottley Erin Zaletel
216.286.2278 216-844-8383
CCF:
Dan Beyer Linda Lewicki
216.444.5848 216.444.5848
Ruth Fritskey
216.444.4801
CWRU:
Isabel A. Sánchez-Cummings, MPA
216.368.6993
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Announcing the Opening of the Newest
Community-Based Research Unit (CB-CRU)
Located at University Hospitals Ahuja Medical Center
Following the announcement of the opening of the UH Bedford Medical Center and the UH Otis Moss Jr. Health center in our March/April Newsletter, we are pleased to announce the availability of the newest community-based clinical research unit to expand research resources to UH academic and community-based research programs and the CWRU Clinical & Translational Science Collaborative (CTSC).
The University Hospitals Ahuja Medical Center clinical research unit will offer dedicated exam room space (equipped with an exam table, a reclining phlebotomy chair, and computer) and is conveniently located on the first floor of the hospital (Room 8) in the UH Harrington Heart & Vascular Institute Suite. It includes a centralized registration area, patient waiting area and free parking for your research volunteers. An outpatient laboratory with a centrifuge for sample processing is also available.
UH Ahuja Medical Center is a state-of-the-art community hospital focused on delivering patient and family-centered care and offering a full range of medical and surgical services to create the ultimate healing environment. We are very excited that they have agreed to join our community-based clinical and translational research initiative to improve the health of Northeast Ohio through innovative research, conducted in community settings.
University Hospitals Ahuja Medical Center joins University Hospitals' community-based clinical research units at Bedford Medical Center and Otis Moss Jr. Health Center to:
- provide the full range of integrated clinical and translational research capability of the UH Dahms Clinical Research Unit in a community setting;
- provide an alternative setting for patients in research studies to be seen without having to travel to the academic medical center; and
- provide research-focused community education programs.
To request use of any of the CB-CRCs, please contact:
Cristina Ferrazzano Yaussy
Community-Based Clinical Research Specialist
Cristina.FerrazzanoYaussy@uhhospitals.org
or dahmscru@uhhopsitals.org
216.286.6684
The Community-Based Clinical Research Centers are supported by the William T. Dahms MD Clinical Research Unit (DCRU) and utilize the research network of the Cleveland Clinical & Translational Science Collaborative of Cleveland (CTSC), UL1TR000439, from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health, to expand clinical/translational research resources available to both academic and community-based research programs.
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The PBRNSR MicroGrant
Supported by the CTSC, the PBRN Shared Resource Core introduced a MicroGrant Program in 2010. It's goal was to catalyze research through the establishment of an easily accessible program for small pilot studies led by practice-based research network (PBRN) members and/or community partners, particularly those focused on clinical translational research in community settings. This low-barrier funding mechanism supports collaborative PBRN pilot studies of $2500-$5000 that yield pilot data for extramural grant applications. Members of the Safety Net Providers Strategic Alliance (SNPSA) PBRN sought funding through the MicroGrant mechanism to conduct a multi-method study to better understand the needs of increasing numbers of elderly patients seeking care at their clinics. The PBRN Shared Resource's Clinical Research Facilitators served as research assistants for the study which determined how the clinics can more effectively engage elderly patients, assess unmet needs, and improve healthcare access. Participants were a sample of elderly patients who had frequently failed to return for follow-up care, who were queried using waiting room questionnaires, telephone surveys, and focus groups. The resulting data are now being analyzed. It is anticipated that findings will support grant applications to develop and test clinical care interventions to improve elderly patients' access, satisfaction with care, and clinical outcomes.
Applications for the PBRNSR MicroGrant are accepted on a rolling-basis. Practices or investigators currently in or willing to join CTSC-affiliated PBRN or community organization (existing or newly created) affiliated with the CTSC are eligible to apply. The PBRN Shared Resource strongly encourages proposals from new or inexperienced investigators. Proposals that represent a new collaboration or that develop infrastructure for translational research consistent with the goals of the PBRN Shared Resource are preferred. Award requests may include supplies, personnel, technical/ software, etc. For further information or to apply for a PBRNSR MicrGrant please contact Amanda Ross in the PBRN Shared Resource via email: amanda.ross@case.edu.
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New CTSC Bioanalyte Core
The Clinical & Translational Science Collaborative has added the Bioanalyte Core to its existing list of cores eligible for the CTSC's rolling deadline Core Utilization Grants.
The Bioanalyte Core utilizes quantitative and qualitative assays to measure bioanalytes including but not limited to cytokines and lipid metabolites. The services can focus on gene expression, secretion and functionality. Samples may be comprised of tissue/cellular extracts, serum/plasma, bronchoalveolar lavage fluid, cerebrospinal fluid, endometrial fluid, tears, and amniotic fluid and cell culture supernatants from mice, rats, rabbits, humans and monkeys. In addition, the Core can develop assays which are not currently commercially available and run clinical samples through certification by the American Board of Medical Laboratory Immunology.
The Bioanalyte Core instrumentation includes:
- ABI Taqman 7000 for basic gene expression and protein array analysis;
- Luminex multi-analyte analysis of soluble bioanalytes and transcriptionfactors;
- ELISA readers for specific proteins not available in the Luminex format and for the development of antibody based assays;
- Luminescence reader for the evaluation of assays based upon the release of luminescence including viability assays;
- cell proliferation assays;
- assays to measure transfection efficiency;
- Chemiluminescence reader for transcription factor activation, ion assays and competitive assays;
- basic flow cytometry to measure cell surface expression of identity markers, activation markers and/or intracellular expression of proteins.
In the near future we will also be able to provide assistance in cell-sorting using our newly purchased BD FACSJazz.
Contacts:
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KL2 Scholar Successes from the CTSC
Ruth Farrell, MD, (KL2 2008-2012), Cleveland Clinic Department of OB/GYN, was
awarded a 2 year research grant from the March of Dimes to study pregnant women's informed decision-making about non-invasive prenatal genetic testing. The award will support a two year period of research from June 1, 2013 - 2015. (Additional info.)
Mehdi Shishehbor, DO, MPH, (KL2 2005-2009), Cleveland Clinic Cardiologist has earned his doctorate in epidemiology at Case Western Reserve University. Pursuing his interest in the epidemiology and treatment of cardiovascular disease, Dr. Shishehbor became the first Cleveland Clinic fellow to be awarded the National Institutes of Health KL-2 award. As a National Institutes of Health scholar, Dr. Shishehbor has a joint appointment at Case Western Reserve University and Cleveland Clinic. (Additional info.)
Desarae LaBeaud, (KL2 2006-2009). Now at the Children's hospital of Oakland, received a large 5 year NIH/NIAID grant as principle investigator to study "The Burden of Chikungunya and Dengue Transmission, Infection and Disease in Kenya". Dr. LaBeaud attributes getting the Masters in Clinical Research from the KL2 Scholar program with definitely helping her prepare for her future research endeavors.
Vikas Gulani, MD, PhD, Former KL2 Scholar (KL2 2007-2012) and now Director of MRI, Assistant Professor, Radiology. A new method of magnetic resonance imaging (MRI) could routinely spot specific cancers, multiple sclerosis, heart disease and other maladies early, when they're most treatable, researchers at Case Western Reserve University and University Hospitals (UH) Case Medical Center suggest in the journal Nature. (Dan Ma; Vikas Gulani; Nicole Seiberlich; Kecheng Liu; Jeffrey L. Sunshine; Jeffrey L. Duerk; Mark A. Griswold. Magnetic resonance fingerprinting. Nature 2013;495(7440):187-192.)
Bennie Jeng, MD, MS, Former KL2 Scholar (KL2 2006-2008). University of Maryland School of Medicine Dean E. Albert Reece, MD, PhD, MBA, has appointed Bennie H. Jeng, MD, MS, a leading expert in cornea and external disease, to serve as the Chair of the School's Department of Ophthalmology and Visual Sciences. Dr. Jeng completed his undergraduate work at Washington University in St. Louis and then earned his medical degree from the Perelman School of Medicine at the University of Pennsylvania. Following an internship at the Cleveland Clinic, he completed his ophthalmology residency training at the Cole Eye Institute of the Cleveland Clinic, where he served as Chief Resident in his last year. He then did his fellowship training in cornea, external diseases, refractive surgery, and uveitis at the Franics I. Proctor Foundation/ UCSF. Upon completion of his fellowship, he returned to the Cleveland Clinic to serve on the faculty, during which time he established a busy medical and surgical cornea practice. During his time at the Cleveland Clinic and UCSF, Dr. Jeng obtained a K12 grant from the National Institutes of Health to fund his research in treating severe ocular surface diseases. He also currently has R01 funding through the U.S. Food & Drug Administration to study a novel compound in healing persistent epithelial defects.
Ronal Hickman, (KL2 2008-2012). The assistant professor of nursing has been awarded the prestigious J. Bruce Jackson Award of Excellence in Undergraduate Mentoring. Before being appointed as an assistant professor at the Frances Payne Bolton School of Nursing, he spent four years developing a program of research focused on innovative interventions to enhance health care decision-making and discovery of genomic biomarkers for chronic respiratory failure. Hickman is among a handful of nurse scientists across the nation who has had the opportunity to receive an institutional career development award (KL2), which is a component of the School of Medicine's Clinical and Translational Science Collaborative of Cleveland. His goal is to develop and test biobehavioral interventions-from face-to-face conversations to innovative eHealth solutions-that provide high-quality decision support to patients and families faced with treatment decisions. (CWRU The Daily: Nursing school's Hickman "pays it forward" and earns Jackson Award for mentoring)
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Save the Date!
Team Science Workshop
October 29, 2013
Wolstein Research Building
12-5pm
Regulatory Affairs 101: Navigating the FDA Process
November 12, 2013
Wolstein Research Building
12-5pm
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Research Concierge
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