A Letter from The Office of the Vice Chancellor for Research

OVCR Annual ReportFiscal Year 2011Clinical Trials – Industry SponsoredClinical Trials – Industry SponsoredExecutive SummaryThe industry-funded clinical studies described in this report are performed by numerous facultythroughout the School of Medicine. There are also a number of centers dedicated to supportingclinical studies across the School of Medicine; some of these centers are highlighted below.Center for Clinical StudiesThe mission of the Center for Clinical Studies (CCS) is to facilitate clinical research of thehighest quality – supporting the effective evaluation of pharmaceuticals, medical devices, andtreatment outcomes – by providing the Washington University research community withadministrative and clinical research services that move trials efficiently from initial proposalthrough study close-out. We assist with clinical research studies supported by federal andfoundation grants and industry contracts, including strong support for investigator-initiatedstudies. Our services include study placement, IRB and other regulatory support and guidance,comprehensive budget development and contract negotiation, recruitment support services(including a centralized research participant database), expert study coordination, dedicatedresearch space and quality improvement initiatives. CCS services facilitate regulatory complianceand operational best practices to optimally support the clinical research endeavor.Center for Applied Research SciencesThe Center for Applied Research Sciences (CARS), established in September 2007 as a corewithin the WU Institute of Clinical & Translational Sciences, represents three units (the ClinicalTrials Unit, the Clinical Research Unit and the Pediatric Clinical Research Unit) at the School ofMedicine which support and conduct clinical studies. The establishment of CARS improvesaccess to specialized clinical research units that contain state-of-the-art resources and wherestudies can be performed safely, ethically and efficiently across a spectrum of study populations,research designs and physical sites.The Clinical Trials Unit (CTU) is located on the 11 th floor of the Center for Advanced Medicine.The unit is an outpatient research unit that offers dedicated research space, equipment, andnursing support for a wide range of clinical studies, particularly multi-center clinical trials. TheCTU generally supports studies that require less sophisticated or intensive measurements andprocedures than those conducted in the Clinical Research Unit.The Clinical Research Unit (CRU) is located on the 4 th and 5 th floors of Barnard Hospital. TheCRU operates as an in-patient and out-patient clinical research unit for studies that require more“intense” nursing services than the studies performed in the Clinical Trials Unit or that requirean inpatient stay. In addition, this unit provides specialized nutritional and lifestyle interventionresearch services, coordinating with the principal investigator to facilitate a comprehensiveexperience for their research subjects. Bionutritional or lifestyle intervention research servicesmay be obtained separately or as part of the visits.68