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The overarching mission of the CRSP is to enable the pivotal link in translational science between basic science and disease-oriented research. The CRSP will provide clinical research facilities to support Northwestern University’s (NU) clinical researchers who require a dedicated research facility with well-developed research resources and well-trained staff. The CRSP will also provide novel resources to investigators who currently lack core support services to move their research findings from the stage of research discovery to the clinic or from the clinic to the community. New CRSP core facilities will provide enhanced infrastructure for existing areas of research strength at Northwestern, as well as provide new resources to evaluate patient-oriented functional outcome measurements. Provide flexible and integrated research resources in Northwestern’s new CRSP to enable new as well as established collaborations between basic and clinical scientists, to enhance rapid translation of discovery into practice, to support a broad portfolio of study designs, and to facilitate recruitment of diverse patient populations. Establish best practices to ensure that all studies using the CRSP meet the highest standards for quality of science, statistical rigor, ethical practices, and participant safety. Collaborate with investigators and NUCATS Institute senior leadership to continuously enhance and facilitate translational research programs.
A major focus of the CRSP is the transformation of our existing GCRC into a new entity that is better-positioned to meet the changing needs of NU’s clinical and translational research community. While a centralized clinical facility for more intensive clinical research studies will continue to be a feature of the new CRSP, the CRSP will transform NU’s clinical research enterprise by working with the other components of the NUCATS Institute to make clinical research resources available in a variety of settings through satellite facilities based in the community and outpatient clinics to support less intensive clinical studies. A particularly important connection for the new CRSP will involve the NUCATS Community-Engaged Research Center. The new CRSP will enhance existing research programs and enable new ones by providing innovative core resources. Transformation of the GCRC into the CRSP will also facilitate integration of ongoing clinical research operations at NU with the other program within the Center for Clinical Research, the Regulatory Support Program.  |
Three active clinical investigators with successful track records of National Institutes of Health (NIH)-sponsored research lead the CRSP. Mary McDermott, MD is program director. She is associate professor of medicine and preventive medicine at the NU Feinberg School of Medicine (FSM). Dr. McDermott is a leading authority on functional impairment and decline in persons with lower extremity peripheral arterial disease (PAD). Dr. McDermott is principal investigator (PI) on four R01 awards from the National Heart Lung and Blood Institute (NHLBI) all of which use NU’s GCRC. Since 1994, she has published 75 peer-reviewed articles. Dr. McDermott is recipient of several national awards, including a Robert Wood Johnson Generalist Physician Faculty Scholar Award (1996-2000), the American Heart Association’s (AHA) Established Investigator Award (2000-2004), and the National Society of General Internal Medicine’s Outstanding Junior Investigator Award (2001). She serves on editorial boards for the Archives of Internal Medicine and the Journal of Gerontology-Medical Sciences. Dr. McDermott’s national leadership includes membership on the American Heart Association's (AHA) Executive Database Steering Committee and recent membership on the national Leadership Committee for the AHA Council on Epidemiology and Prevention and the Interdisciplinary Working Group for Atherosclerotic Vascular Disease. Alan H. Kadish, MD serves as associate director and has primary responsibility for leading the investigator-initiated clinical trials unit (CTU). Dr. Kadish is the Chester and Deborah C. Cooley Professor of Medicine, senior associate chief of the Cardiology Division and the director of the Cardiovascular Clinical Trials Unit. He is an active investigator in National Institutes of Health-sponsored studies that include experimental research, physiologic studies, industry sponsored research, and large scale clinical trials. Currently, he is actively involved in initiating two large scale, multi-center clinical trials: (1) the DETERMINE trial – a study of defibrillators in patients with coronary disease that will examine new risk stratification techniques to select patients for device implantation; and (2) PACE-MI trial – a study of the role of pacemaker and beta-blocker therapy in patients with bradycardia after myocardial infarction. He is PI and Co-I on NIH RO1s and is primary mentor for three K awards. Dr. Kadish is author of 200 peer-reviewed manuscripts and is a fellow of the American Society for Clinical Investigation. Rosalind Ramsey-Goldman, MD, DrPH, also an associate director, is responsible for the clinical research facility of the CRSP. She is a professor of medicine and current program director of NU’s GCRC. Her clinical research focuses on the long-term consequences of systemic lupus erythematosus (SLE), its prevention and complications. Dr. Ramsey-Goldman is principal investigator for the Patient-Oriented Clinical Research Program in SLE at Northwestern. This research program is mainly funded by NIH grants (P60, PO1, RO3, U01, K24 project and core grants) and private foundations. Dr. Ramsey-Goldman has published over 100 peer-reviewed and invited papers. She serves as the associate director of the Multidisciplinary Clinical Research Center in Rheumatology and co-director of clinical research training for the NIH-funded T32 Rheumatology Training Grant at the University. She has been a mentor for NU’s NIH-funded K12 Mentored Clinical Research Scholar Grant. As a mentor, she has guided more than 20 medical students, residents, graduate students, rheumatology fellows, and junior faculty. Her mentoring talents have been recognized by an NIH-funded K24 mentor award that has received 2 rounds of competitive funding. Dr. Ramsey-Goldman was named as a Kirkland Scholar Awardee in 2006, a national honor awarded to a senior SLE investigator in recognition of clinical research accomplishments and leadership in motivating young investigators to direct research careers towards SLE. She chairs the SLE International Collaborating Clinics group and is a standing member of the Neurological, Aging and Musculoskeletal Epidemiology study section at NIH. Our plans for the CRSP are built on current ground-breaking clinical studies led by NU researchers. Principal investigators from 19 departments and divisions are currently engaged in research on the GCRC at Northwestern Memorial Hospital (NMH) and Children’s Memorial Hospital (CMH). During the past 5 years, total outpatient visits have increased by 88%, and total inpatient research days have averaged an increase of 11% over the previous grant cycle. The number of active protocols served increased over 70%, and the number of investigators more than doubled. In grant year 2005-06, the NU/NMH GCRC provided clinical resources to leverage over $19.2 million in funding for investigator-initiated research projects, including $15.5 million of NIH funding. Our Pediatric GCRC satellite unit at CMH demonstrated the most active growth, increasing outpatient activity from 21 visits in 2001-2002 to 1,301 visits in 2005-2006. With the transformation of the GCRC into the CRSP, NU's research community will continue to grow into even more far-reaching programs. | |
