The Duke Clinical Research Unit (DCRU), formerly known as the Duke-Rankin General Clinical Research Center, provides the clinical research infrastructure to support investigators in the design, initiation, conduct, and reporting of interdisciplinary and collaborative clinical research to help understand human conditions, translate basic research findings into patient care, and develop new therapies.

The DCRU's mission is to provide a unique model for the conduct of early phase clinical research that accelerates the development of new medical therapies by:

• Applying advanced technologies to better understand disease and predict drug response
• Combining medical and scientific expertise with operational excellence, efficiency and regulatory compliance
• Offering a hospital-based environment to maximize subject safety
• Studying special patient populations as well as healthy volunteers

Central to the mission of the DCRU is a commitment to an environment that fosters the development of the next generation of clinical investigators.

The scientific focus for the DCRU includes the following:

• Discover pathways through probing of biological targets
• Develop novel biomarkers of disease and drug response
• Promote the early identification of safety signals as well as on target and off target effects
• Use a systems biology approach, advanced imaging and “omics” (genomics, proteomics and metabolomics) to measure the physiological effects of medical interventions
• Reclassify disease and develop molecular signatures to predict response, non-response, and toxicity

John McHutchison, MD DTMI - Program Director, Duke Clinical Research Unit (DCRU) Associate Director, DCRI Director, DCRI Gastroenterology and Hepatology Research Dr. McHutchison, a professor of medicine at Duke University Medical Center, joined the DCRI in 2002 as the director of the DCRI’s Gastroenterology and Hepatology Research division. Dr. McHutchison’s clinical and research interests relate to chronic viral hepatitis B and C, ascites, noninvasive fibrosis markers, steatosis, and the immunopathogenesis of these diseases.

Cathy Lavin, RN, MHA
DTMI - Operations Director, Duke Clinical Research Unit (DCRU)

• 10 years clinical trials experience
• Coordinated and monitored Phase I-III drug and device trials in multiple therapeutic areas:
  -- cardiology, otolaryngology, renal dialysis/nephrology, hepatology, and anesthesiology/surgery
• Duke hospital administrator for 20+ years:
  -- oversight of IRB, regulatory compliance, risk management, medical records, performance improvement, infection control,
  and medical staff credentialing
• Served as Executive Director of the inpatient physician hospitalist program
• 5 years as Emergency Department Nurse

Vivian West, PhD, MBA, RN
DTMI - Project Leader, Duke Clinical Research Unit (DCRU)

• 12 years clinical research experience:
  -- positions include project manager, project director, clinical research director, co-investigator
• Coordinated and monitored Phase I-IV drug and device trials
• Provided oversight for IRB submissions, regulatory compliance, budget development and monitoring, and study conduct
• 20+ years clinical experience in various management and administrative roles:
  -- ICU/CCU, oncology, cardiology, diabetes, infusion therapy

Barry Mangum, PharmD, FCP
DTMI - Director, Clinical Pharmacology, Duke Clinical Research Unit (DCRU)

• Associate Professor, Division of Clinical Pharmacology, Department of Medicine
• Designed and implemented global clinical research programs in over 35 countries for 30 multinational pharmaceutical companies
• 16+ years of Phase I- IV clinical trials and experience with over 40 clinical programs
• Co-author of NeoFax: A Manual of Drugs Used in Neonatal Care, the leading neonatal pharmacology dosing publication globally

Shein-Chung Chow, PhD
DTMI - Faculty Statistician, Duke Clinical Research Unit (DCRU)

• Professor, Department of Biostatistics and Bioinformatics
• Almost 20 years experience in pharmaceutical/clinical research and development
• Expert in biopharmaceutical statistics for studies conducted in the areas of BA/BE, PK/PD, and clinical trials (published 170 statistical methodology papers and 14 books)
• Currently leading the effort for statistics collaboration between Duke and FDA