A Letter from The Office of the Vice Chancellor for Research

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OVCR Annual ReportFiscal Year 2011Clinical Trials – Industry SponsoredThe Pediatric Clinical Research Unit (PCRU) provides space, nursing and bionutritional supportfor clinical research projects conducted with children at Washington University. The unit is onthe 11 th floor of St. Louis Children’s Hospital and has exam and interview room space, aprocedure area and a phlebotomy and sample processing area.Siteman Cancer CenterThe Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington UniversitySchool of Medicine in St. Louis is an international leader in cancer treatment, research,prevention, education and community outreach. It is the only cancer center in Missouri andwithin a 240-mile radius of St. Louis to hold the prestigious Comprehensive Cancer Centerdesignation from the National Cancer Institute. The Siteman Cancer Center offers manydifferent types of clinical trials. At any given time, Siteman has more than 250 clinical studies,including many collaborative efforts with other leading cancer centers throughout the country.There are different types of clinical trials performed at Siteman. Therapeutic trials involve sometype of treatment, such as a new drug, combination of new and/or existing drugs or a newcombination of therapies (for example, changing the schedule of the chemotherapy andradiation therapy). They are aimed at patients who have already been diagnosed with cancer.Other trials are designed to prevent cancer in healthy people or control cancer in people whohave had curative treatment.Recruitment Enhancement Core (REC)In order to improve patient accrual in clinical studies, the Regulatory Support Center (RSC)within the Institute of Clinical & Translational Sciences supports a program called RecruitmentEnhancement Core (REC). The goal of the REC is to assist investigators in recruiting potentialparticipants while ensuring compliance with all relevant regulations, including informed consent,confidentiality, privacy of health information, and the recruitment of women andunderrepresented minorities. The REC provides investigators with pre-qualified, pre-screenedand potential research participants. The service increases public awareness and knowledgeconcerning medical research needs and opportunities, and the increasing need for minorityparticipation. This education of the community is done in a variety of ways, including radio andprint advertising as well as targeted health fair promotion. This paradigm shift has beenachieved by utilizing a pre-existing WU medical center resource called Volunteer for Health(VFH). The Washington University VFH recruitment program was established in September1998 and has assisted investigators in recruitment of study participants since that time. Thisprogram includes a database, called the Research Participant Registry, with profiles of potentialsubjects in a variety of therapeutic areas, as well as assistance with on-campus and/or mediaadvertising. Currently, the database contains more than 15,000 interested, consented volunteersand the REC is dedicated to developing and implementing strategic, recruitment plans thatimpact recruitment, university wide.69
OVCR Annual ReportFiscal Year 2011Clinical Trials – Industry SponsoredAIDS Clinical Trials Unit (ACTU)The Washington University AIDS Clinical Trials Unit (ACTU) was established in 1987 toconduct clinical research and participate in clinical trials for persons with HIV-associateddisease. Since 1987, the Washington University ACTU has been a highly productive participantin the AIDS Clinical Trials Group funded by the National Institute of Allergy and InfectiousDiseases. It conducts NIH, CDC and industry sponsored and Washington Universityinvestigator initiated clinical research trials of potential treatments for HIV and its co-infectionsand complications. Well established and active in the community, the ACTU provides access toresearch trials, community outreach and education, continuing education, and consultation forhealth care professionals. Currently, clinical trials at the ACTU are studying the aging andmetabolic effects of long term HIV infection, treatments that may stop HIV’s destruction of theimmune system; treatments that might help reduce HIV associated inflammatory, metabolic andneurological complications. Since 1988, more than 6000 individuals have participated in studiesoffered at our site.Oriented Research Unit (Pediatrics)The Patient Oriented Research Unit (PORU) has dedicated space on the 10th floor of theNorthwest Tower and serves as an academic base for the interaction and collaboration of clinicalinvestigators within the Department of Pediatrics. Administrative members of the PORU assistmembers of the Department with submission of human studies protocols to the Internal ReviewBoard (IRB) and with preparation of clinical research grants and contracts. PORU investigatorsare studying a variety of clinical topics, including diabetes, asthma, sickle cell disease,hypertension, cancer predisposition, organ transplantation, smoking cessation and many others.Beyond physicians, participants in these studies include psychologists, epidemiologists, andbiostatisticians.Industry Sponsored Clinical Trials – FY09-FY11The number of Industry Sponsored Clinical Trials performed at Washington University hasremained stable over the last three fiscal years while the revenue received from the trials has seena slight decrease. Over the three year period, the number of clinical trials performed at theinstitution has decreased from 1,348 trials in fiscal year 2009 to 1,341 trials in fiscal year 2011(-1%). During that same time, the cash receipts from those trials have decreased by 2% from$27.3 million in 2009 to $26.7 million in 2011. For a break-down of clinical trials by departmentof the School of Medicine please refer to Table 1.Of the total trials performed at the School of Medicine in 2011, 711 out of 1,341 or 53% wereperformed in the Department of Internal Medicine. In dollar terms, this represents 50% of thetotal clinical trial dollars for fiscal year 2011. For a break-down of clinical trials by Division ofthe School of Medicine’s Department of Internal Medicine, please refer to Table 2. Also, duringthe period fiscal years 2009 to 2011 the number of new industry-funded, clinical research-relatedagreements and amendments has increased by 15%, while the number of new industry-fundedClinical Trial Agreements has decreased by 9% as is shown in Table 3.70
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A Letter from The Office of the Vice Chancellor for Research

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