The 2nd Department of Pediatrics of the Semmelweis University is the only accredited Phase I Unit for clinical pharmacological studies of children in Hungary. The Department possesses one of the longest experience and tradition in diagnosis and treatment of pediatric diseases in Hungary. In addition to the whole spectrum of diseases in infants, children and adolescents the hospital is the Hungarian National Center of Pediatric Oncology and Childhood Hematologic Malignancies. The accreditation for Phase I Clinical Study Unit was completed in 2007. In the past 25 years more than 100 clinical pharmacology studies have been successfully completed.
Spectrum of clinical studies: allergic diseases, asthma and respiratory diseases, immunology, infectious diseases, inborn errors of metabolism, pediatric hematology, pediatric oncology, pediatric neurology, pediatric gastroenterology, pediatric cardiology and vascular disorders, pediatric ophthalmology, pediatric rheumatology, pediatric endocrinology, pediatric surgery.
Head of the Phase I Clinical Study Unit and principal investigator is Prof. Dr. György Fekete, PhD, DSc, FRCP, specialist in pediatrics, clinical pharmacology, and clinical genetics.
- Study Planning and Management on site
- Recruitment of patients/volunteers
- Full service pharmacy
- 24 hours and weekend central temperature control with alarm systems work in the Phase I Unit wards as well as in the pharmacy, continuously
- Laboratory procedures
- Fully equipped 5 beds in Phase I Clinical Study Unit wards
- Fully equipped 5 beds for accompanying parents of study patients in the wards
- Intensive care unit with 4 beds
- Pediatric anaesthetist team has a 24 hours duty
- Full service pharmacy
- 24 hours and week – end central temperature control with alarm systems work in the Phase I Unit wards as well as in the pharmacy, continuously
- outpatient clinic with 4 special examination rooms for clinical studies
- study office and archive rooms for documentation at investigators’ and study participants’ disposal
- blood and urine sample processing occurs according to GCP phase I prescriptions
- all participant physicians, nurses, pharmacists, laboratory assistants are specially skilled for phase I clinical studies.
- local clinical chemical laboratory
- local cytogenetic and molecular genetic (DNA) laboratories
- fridges, freezers, centrifuges with cooling system