Department of Preventive Medicine

Division of Clinical Trials

The goals of this division are to conduct epidemiologic, behavioral, clinical and health-services research in areas of chronic disease, health of underserved populations, and women's health. Among the many large, multicenter clinical trials that have involved this division are such NIH-sponsored studies as FAST (Fitness and Arthritis in Seniors Trial), Health ABC (Health and Body Composition), Look AHEAD (Action for Health in Diabetes), SHEP (Systolic Hypertension in the Elderly), TONE (Trial of Nonpharmacologic Interventions in the Elderly), and WHI (Women's Health Initiative). This division also has many community-oriented projects reaching out to area hospitals, schools, community centers, and local clinics. In addition, the division is very active in conducting pharmaceutically sponsored research studies.

Two locations are maintained for the chief clinical-trials sites, one in the midtown medical-center area and another in east Memphis. Both clinical sites are under the direction of an administrative/clinical director and research director, each with at least twenty years of clinical-trials experience. The sites are staffed by research nurses, nurse practitioners, technicians, and other supportive personnel. The sites are all equipped with file servers, computers, fax machines and copiers. Each study coordinator maintains a clinical database for monitoring adherence, visit-windows, missed visits, compliance, and other information on all study subjects. This type of database tracking has proven invaluable for both the monitoring and success of all our large trials.

Midtown Memphis Clinic (66 N. Pauline Street)

This location has 9,000 square feet for clinic space, recruitment areas, data management, and offices. Space includes a large waiting room; reception area; medical records storage; twelve exam rooms, two of which are equipped for gynecological examinations, and a laboratory staffed with research technicians and fully equipped for blood collection, processing (with two minus-70 degree freezers, a refrigerator and two refrigerated centrifuges), and shipping. The site has eight random-zero sphygmomanometers for use in various clinical trials. In addition, there are two procedure rooms, one containing a Hologic 4500 bone densitometer capable of measuring bone mineral density and total body composition, and the other with KinCom equipment to measure kinematic strength. We also have a treadmill with metabolic cart capable of doing VO2 max treadmills.

East Memphis Clinic (756 Ridge Lake Boulevard)

The east Memphis location has 5,000 square feet devoted to clinical space, nutrition intervention and behavioral modification space. The clinical space is comprised of a waiting area, reception area, and medical records storage area. There is a procedure room containing a Hologic densitometer, which is capable of measuring bone mineral density and total body fat composition; a laboratory area equipped for blood collection, processing (with refrigerator, a minus-70 degree freezer and a large, refrigerated centrifuge), and shipping. This clinic has 4 exam rooms, each equipped with a full examination table and a desk area. Two of the rooms are equipped to provide for gynecological examinations. In addition to the exam rooms, there is office area for medical and support staff. The intervention space is staffed by a master's-prepared nutritionist and a master's-level exercise specialist. This space has a reception area, small food-preparation area, a large meeting room, 3 offices, and storage areas. This intervention team has extensive experience in individual as well as group nutritional intervention settings. Specialties include NDS evaluations, sodium counseling, weight-control counseling, and various food-recall and food-record data collection.

Recruitment Unit

The Division of Clinical Trials has an experienced recruitment unit devoted to publicity, public contact, and telephone screening to select participants for ongoing studies. This unit, located at the midtown medical-center site, has a director, outreach specialists, office supervisor, and recruitment technicians. This unit is responsible for all participant-selection activities. Staffing patterns allow flexibility and ensure an adequate number of screeners to initiate and respond to all recruitment strategies in order to meet the project goals. The unit has expertise in such strategies as direct mail, health fairs, group presentations, blood pressure/cholesterol screenings, newspaper inserts, posters, media ads and articles, radio/television commercials, public-service announcements, and general mass mail, capable of producing up to 34,000 pieces of mail per week on the department's direct-mail printer. Amounts ranging up to one million pieces of mail are sent out annually through this department for recruitment purposes. Publicity efforts are coordinated by a public-relations coordinator, who is responsible for the development and placement of print and electronic media products and has expertise in materials development, desktop publishing, and media productions.

Data and Quality Control Unit

A large component of our organization is the data and quality control unit, led by a manager with at least twenty years' experience in clinical trials research. The unit staff is responsible for all the data entry and data editing on clinical trials conducted by the department at each site, both by hard copy and electronic transmission. Before entry into the study-specific database, all study data are reviewed for completeness by at least one of the data staff.

Quality control is an essential part of every research study. The major function of quality control is to assure that protocol-specific certifications and equipment maintenance schedules are met, as well as to observe staff for appropriate implementation of protocol activities.

Related links:

• Research
• Volunteers Needed for Research Studies
• Statistics and Methodology Consulting