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WE BELIEVE IN THE
TRANSFORMATIVE POWER
OF RESEARCH, THAT’S WHY
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WE DO ALL WE CAN TO SUPPORT EVERY AMAZING PATIENT WHO STEPS UP TO PARTICIPATE IN A CLINICAL STUDY.
— Julie Rosenthal, M.D., M.S.
Julie Rosenthal, M.D., M.S., James Green, CCRP, Lianne Shami, B.S., Kevin Haynes
KCRC Assists in Michigan Medicine Research with Consequences for Eyes At Kellogg, research involving patients is coordinated through the Kellogg Clinical Research Center (KCRC). The KCRC provides the staff, infrastructure and resources to see a clinical study from initial Institutional Review Board approval through final data reporting. Since opening its doors in 2015, clinical research volume at the KCRC has grown to more than 360 active studies, including more than 300 investigator-initiated studies and 50+ sponsored studies. Along with coordinating the hundreds of patient interactions and protocol details required for those projects, a special team within the KCRC assists researchers from other Michigan Medicine departments whose studies have potential consequences for eye health. “Many treatments for cancers and other diseases have potential ocular side effects,” explains Julie Rosenthal, M.D., M.S. The Associate Medical Director of the KCRC, Dr. Rosenthal oversees the Collaborative Ophthalmic Research Support (CORS) unit. “The clinical trials that evaluate those medications have specific protocols for monitoring participants’ eyes. Our team coordinates all of those eye-related components.” Along with Dr. Rosenthal, the CORS team includes KCRC Administrative Director James Green and Clinical Research Coordinators Kevin Haynes and Lianne Shami. A CORS study protocol—which can exceed 100 pages— is first thoroughly reviewed and its eye-related components consolidated. A plan is developed, detailing the required testing, imaging and measurements, and identifying which Kellogg specialists are needed. 16
With a plan in place, every patient interaction is managed through the ODS team to streamline the process for everyone involved. “Without this centralized service, patients might be seen by Kellogg physicians without knowledge of the protocol, which could lead to incorrect or incomplete examinations and testing,” notes Dr. Rosenthal. “This could jeopardize the viability of the studies of our Michigan Medicine research partners.” “Most appointments begin with a workup at the KCRC, after which Kellogg doctors complete the examinations,” explains James Green. “It’s quite a scheduling challenge,” adds Kevin Haynes. “We try to work with the patient’s existing study appointments, to minimize trips to the medical campus, and coordinate with the availability of the right Kellogg specialists for exams and imaging.” Currently, the KCRC is providing support for more than 60 active CORS studies, coordinating with researchers in endocrinology, oncology, neurology, immunology, pediatrics and more. “In a cancer drug trial, we may be monitoring for side effects like changes in vision or intraocular pressure,” Lianne Shami explains. “In studies of genetic syndromes, we may be watching for visible changes in the cornea, in the case of Wilson’s disease, or the development of tumors in Von Hippel-Lindau disease.” A comprehensive resource like the KCRC is rare, even in the largest academic eye centers. Extending that same high level of support to researchers in other specialties is a testament to Kellogg’s commitment to cooperation in advancing in research while delivering outstanding patient care. “We believe in the transformative power of research,” says Dr. Rosenthal, “That’s why we do all we can to support every amazing patient who steps up to participate in a clinical study.”