Divisions & Faculty

The Clinical Research Unit (CRU), a division of the department of pediatrics, offers children and their families within the Hampton Roads community the opportunity to participate in national clinical trials for new and improved pharmaceuticals.  The unit also offers research support services to faculty within the Department of Pediatrics and other research faculty throughout Eastern Virginia Medical School.

Eastern Virginia Medical School was established in 1973. EVMS has approximately 400 M.D. students, 200 students in various health profession programs, 300 residents and fellows, and more than 200 full-time faculty. Many CRU studies are carried out at Children's Hospital of the King's Daughters, or CHKD. CHKD was established in 1961. It is the only free-standing, full-service, not-for-profit pediatric hospital in Virginia. CHKD has 212 beds, had more than 6,200 inpatient admission and more than 171,600 outpatient specialty and surgical clinical visits in the past year.

Information for Potential Participants

Children receive attentive, expert care from outstanding medical practitioners when parents enroll them in clinical studies offered by the Clinical Trials Unit of Eastern Virginia Medical School.  Parents feel good about their participation because their support allows doctors to gain important information to better protect all children from disease.  We also offer adult studies, providing the same caring attention to subjects of any age.

Each clinical trial is different, but in all cases the health of the patient is of the utmost importance. Clinical research experts carefully analyze information collected about study subjects.  The results enable investigators, drug and medical equipment manufacturers to produce the most effective medicine and treatments for childhood and adult illnesses.  Some results help doctors actually prevent diseases.  

Study subjects receive investigational treatments and medical care under close supervision by physicians and other research professionals.  Industry-sponsored trials have been developed by respected pharmaceutical and biotechnology companies, and are reviewed by the US Food and Drug Administration. 

When volunteers participate in a study, their health is carefully monitored throughout the trial.  It is important that subjects and pediatric subjects’ parents follow all instructions from the study staff, take all prescribed medicines, keep all scheduled appointments, and report any symptoms the subject may experience no matter how small they may seem.  Subject safety is our top priority.  So is privacy.  Medical records always remain confidential and trial results provided to the pharmaceutical company never include names of subjects or their families. 

Data Collected Contributes to Medical Knowledge 
After each study, information from all subjects is analyzed to determine if the investigational treatment is working.  Results are also analyzed to verify that the treatment is safe and to note any side effects.  The FDA closely reviews these results before approving any new drug for general public distribution. Even after approval, companies continue to study drugs and compare them to other treatments for effectiveness and safety.  Involvement as a study volunteer is extremely important in bringing this knowledge to the medical community and the benefits to people worldwide. 

Supported by Trusted Experts 
Staff and faculty from Eastern Virginia Medical School are closely involved in our research.  So are pediatricians at Children’s Hospital of The King’s Daughters and from around the region.  Over seventy local pediatricians participate in our pediatric trials.  These doctors appreciate the value of clinical studies and know how important the results are for all children.  The Clinical Research Unit conducts from 20 to 25 clinical trials at any time.  Children of all ages can participate, and several adult studies are valuable.  Whether you participate in one or several of our trials, we thank you for your involvement. 

Professional Inquiries

The Clinical Research Unit provides assistance to investigators of all research experience levels for all research support needs, whether your study is investigator-originated, part of a national protocol or an industry-sponsored research project.  Our research staff is expert in Good Clinical Practices, and has experience in conducting industry-sponsored Phase I, II, III, and IV clinical trials.  Our 15-year history includes conducting trials evaluating vaccines and infant formulas as well as assisting with projects in pediatric sub-specialties including allergy, neonatology, nephrology, otolaryngology, endocrinology, gastroenterology, genetics, infectious diseases, and sickle cell disease. 

 Our experience extends to assisting principle investigators with their grants from National Institutes of Health, Centers for Disease Control, and other federal and private funders, with a full scope of services from research design and measurement, to grant application, research assistance and manuscript editing.  We also assist residents in their research projects and are often successful in helping them find funding for their projects as well. 

 Investigators within the Department of Pediatrics may request full study support, consisting of budget and contract negotiation, completion of regulatory documents, and full coordinator support.  In addition the CRU can provide assistance with study design, database development, data management, statistical analysis, and manuscript assistance.  Coordinator orientation and ongoing educational consultation is available to assist the investigator’s clinic staff that are new to research, but assuming some coordinator responsibilities. 

 The Clinical Research Unit provides assistance to faculty, house staff, and other staff members from the inception of the research question through data collection, analysis, and manuscript submission.

Current Clinical Trials (November 2008 Update)

You are invited to enroll your child in any of the research studies at no cost to you.  If you are interested in finding out more about clinical trials research, or any of these studies, or if you would like to enroll your child, contact the study coordinator listed.  The Clinical Trials Unit is a program of Eastern Virginia Medical School.