Pediatric Clinical Research Unit
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.
Many CRU studies are carried out at Children's Hospital of the King's Daughters, (CHKD). CHKD was established in 1961 and is the only free-standing, full-service, not-for-profit pediatric hospital in Virginia. It boasts 212 beds lending to more than 6,200 annual inpatient admissions and over 170,000 annual outpatient specialty and surgical clinical visits.
The Clinical Research Unit provides assistance to investigators of all research experience levels for all research support needs, whether the 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 20-year history includes conducting trials evaluating vaccines and infant formulas as well as assisting with projects in pediatric sub-specialties including allergy, neurology, nephrology, otolaryngology, endocrinology, gastroenterology, genetics, infectious diseases, pulmonary, sickle cell disease, and cardiology.
The Clinical Research Unit provides assistance to faculty, house staff, and other staff members during study setup, enrollment, and data collection.
Information for Potential Participants
Children receive attentive, expert care from outstanding medical practitioners when enrolled in clinical studies offered by the Clinical Research 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. EVMS also offers 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 and drug and medical equipment manufacturers to produce more 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
- report any symptoms the subject may experience, no matter how small they may seem
Subject's safety and privacy are our top priorities. 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 use. 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 all over 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 20 to 30 clinical trials at any time. Children of all ages can participate, and several adult studies are available. Whether you participate in one or several of our trials, we thank you for your involvement.
Current Clinical Trials
You are invited to enroll your child in any of our research studies at no cost to you. To learn more about current trials underway and how to participate, or to simply find out more about clinical trial research, please contact the CRU by phone at (757) 668-6416.