General Clinical Research Center (GCRC)

William Malarkey, MD, Director

2006 was an exciting year for Ohio State University’s General Clinical Research Center, which has approximately 100 active protocols from 39 departments in 10 colleges. Much of the research in this Center is interdisciplinary, and GCRC investigators continue to be supported via national funding agencies such as the National Institutes of Health.

Ongoing Research Programs

Agriculture – Testing the validity of a simulated environment with dangerous farm equipment using endocrine measures to validate stressful simulations
AIDS/HIV – Phase I clinical trials for HIV-infected subjects requiring hemodialysis
Autism – Attention Deficit Hyperactivity Disorder symptoms in autism; Risperidone and behavior therapy in children with pervasive developmental disorders; oral human immunoglobulin in autism
Behavioral Medicine – Olfactory sensitivity and physiological responses; caregiver stress in parents of children with mood disorders; chronic stress and immune function
Cancer – Stress and immunity project for women with breast cancer; oral cancer studies; prostate cancer and lycopene supplementation
Cardiology – Management of patients with heart failure; chronic heart failure and survivors of an acute myocardial infarction
Community – Resource and education projects in Appalachian areas involving smoking cessation; cancer and health behavior; nutrition, cancer and the Amish
Critical Care Medicine – Obese critically ill: outcome and process disparities
Diabetes – Prevention trials; hyperglycemia and hyperinsulinemia; type 2 diabetes mellitus; natural history in African-Americans; management of type 2 diabetes mellitus by conjugated linoleic acid (CLA)
Economics – Understanding human response to economic risk with MRI and genetic polymorphisms
Endocrinology – Metabolic energy requirements for normal menstrual function; insulin resistance; adiponectin in people of West African ancestry
Exercise – Exercise as therapy for asthma; yoga, exercise, immune function and health; insulin resistance in football players
Neurology – New therapies for amyotrophic lateral sclerosis; multiple sclerosis; spinal muscular atrophy; myasthenia gravis; muscular dystrophy; effects of psychosocial stress and genetics on cognition
Nutrition – Lifestyle and body weight changes in young females; breast cancer risk in overweight and obese premenopausal women
Obesity – Aging, stress and chronic inflammation
Obstetrics and Gynecology – Gestational diabetes and inflammatory markers; vaginal ultrasound cerclage trial; psychosocial factors associated with inflammatory and antibody responses to influenza vaccination in pregnancy
Ophthalmology – Idiopathic intracranial hypertension
Pediatrics – Hypothalamic pituitary adrenal axis function in adolescent antisocial females; growth hormone and endothelial function; natural history study of the development of type 1 diabetes; childhood obesity; hypoglycemia and endothelial function; health consequences of sleep apnea in obese children and its association with gastroesophageal reflux
Pulmonary – Alveolar macrophage proteomics in HIV-associated emphysema; COPD in patients with AIDS; pulmonary rehabilitation exercise on biobehavioral outcomes in COPD
Renal – Genetic and clinical risk factors for human SLE nephritis; African-American study of kidney disease and hypertension; influence of fenofibrate therapy on kidney function in CKD patients
Smoking Cessation Studies – Nicotine dependence; race and nicotine metabolism
Stress – Stress and wound healing; chronic stress and immune function; caregiver stress and chronic inflammation; Omega-3 dietary supplementation, immune function, and mood
Surgery – Gene expression profiles in healing and non-healing wounds
Transplantation – Bone architecture in patients with renal transplant; living unrelated kidney donor and sibling follow-up
Education – The GCRC Mentoring Program, directed by Philip Diaz, MD, over the past year has recruited young physicians interested in clinical research and is preparing them to implement research proposals. In 2006, eight protocols were submitted by GCRC mentees. A K23 application prepared by Naeem Ali, MD, was funded. In addition, Dara Schuster, MD, associate program director, has established an introductory course on clinical research. Its objectives are to introduce undergraduates to clinical research as a career opportunity, to teach basic skills with didactic lectures and hands-on training, and to provide a mentored experience in clinical research.

Research Accomplishments of 2006

The GCRC is an important partner of a 2005- awarded T32 grant entitled “Eliminating Barriers to Effective Training in Clinical Investigation,” a grant directed by Philip Binkley, MD. Only 10 of these grants were funded nationally. Funded through August 2010, this training proposal in predoctoral clinical research will propose solutions to major barriers to effective training and present a strategy for determining whether the curriculum addresses a critical need for increasing numbers of clinician scientists. Specifically, this program provides predoctoral nursing, dental and medical students with an innovative curriculum of biostatistics, study design and ethical conduct of research in an interactive team-learning approach, delivered as a core curriculum to all students in these respective programs at Ohio State and at outside institutions for whom videoconference participation will be offered. These students can enter a short course in clinical research and an intensive year-long curriculum culminating in a master of public health degree with emphasis in clinical investigation.
Nursing – Approximately 30 percent of GCRC protocols involve pediatric participants. As of this year, 100 percent of RNs on the unit have completed or maintained their Pediatric Advanced Life Support training. Also, the majority of nurses are certified in Advanced Cardiac Life Support as an increasing number of protocols require exercise testing.
Bionutrition – The resources (diet assessment, body composition and metabolism, and cardiovascular testing and human performance) of the GCRC’s Bionutrition Core have been increasingly used by investigators. The Center has developed an ability to enter body composition data directly into databases from a bedside tablet computer. Bionutrition research training programs for nurses, technicians and students are being developed.
Core Laboratory – The Laboratory Core, composed of processing and analytical laboratories, provides analytical support for investigators. The present menu, which is expanding, contains research assay panels in: endocrine and neuroendocrine; metabolism, diabetes, obesity; inflammatory; and bone assays.
Informatics – The Informatics Core offers services in database management, administrative computing and project management. A major piece of software written in 2006 by Informatics personnel makes research patient scheduling more efficient. This application is written in mod_perl using a PostgreSQL database and is released under the GNU General Public License. Consequently, this open-source program will be freely available to GCRCs nationally.
Research Subject Advocacy (RSA) – The Center’s Research Subject Advocacy program, which began in 2002, ensures that GCRC studies are designed, implemented and conducted safely and ethically, affording the highest priority to the protection of human subjects. The RSA is a resource and adviser to GCRC personnel, prospective and current researchers, human subjects/research participants, and the GCRC Advisory Committee (GAC).
Emerging Clinical Programs – The GCRC is strengthening its connection with new clinical programs, such as the Center in Chronic Wound Healing. The GCRC is participating in the growth of this Center, which will be a coordinating center for 16 university wound-healing programs across the country. One protocol has already been received for evaluating microarrays and proteomics from wound biopsies obtained from chronic wound patients to better understand the pathogenesis of wounds. And one paper published by this group and supported by GCRC resources is entitled, “Wound site neutrophil transcriptome in response to psychological stress in young men” (Gene Expression, 2005).
CTSA Development and Opportunities – GCRC staff have been involved in the CTSA process, which led to a grant submission in January 2007. As part of this process, the GCRC will be incorporated into the Participant and Clinical Interactions Resources (PCIR) Core, which provides a highquality, ethical, safe and cost-effective environment that fosters education and training while encouraging participation by the community and investigators in clinical and translational lifespan research. To transform the GCRC structure, the Center incorporated various Health Sciences and community clinical and translational resources into the PCIR, which will link to the other key functions of the CTSA. Other areas to be integrated into the PCIR include:

Columbus Children’s Hospital Clinical Studies Center – This is a 3,000-square-foot facility on the sixth floor of the Outpatient Care Center on the Children’s Hospital campus. The facility is staffed by eight clinical research nurse coordinators and a psychometrician trained in psychometric assessments. It is equipped to perform: specimen sample collection, processing and storage; research subject recruitment; and data collection and management.

Comprehensive Cancer Center Clinical Treatment Unit (CTU) – Housed in the Medical Center’s James Cancer Hospital and Solove Research Institute, the CTU has 1,700 square feet for outpatient studies involving phase I and II chemotherapy protocols.

To enhance its community translational component, the GCRC has incorporated two additional units as “laboratories” to create a “research unit without walls”:

Primary Care Practice – Based Research Network for Pediatric and Adult Patients (PBRN) – This is a network of 24 primary care sites throughout central Ohio that serves as a community-based translational research laboratory for a research faculty with members from nine colleges and 22 departments at Ohio State, including Pediatrics.
Ohio Extension Service – The Ohio Extension Service is part of the College of Food, Agriculture and Environmental Sciences at Ohio State. Extension supports operations in all 88 counties of Ohio. A major focus involves linking local community needs with Ohio State researchers. Community-based health-related research is a major thrust of Extension.