한국의 신생아 대상 임상시험

초록

The survival rates of high-risk infants and premature infants have increased, and the morbidity rates among survivors have decreased with the recent developments in neonatal intensive care. However, in the real neonatal care practice, many drugs, medical devices and treatment protocols have been used based on results of studies in adults or older children, despite their lack of proven safety and efficacy in neonates. In the Western developed countries, although pediatric clinical trials have been activated by several efforts of the government or national union, clinical trials targeting newborn or premature infants remains a challenge. Recently, political movements and efforts to promote pediatric clinical trials have been started in Korea, increasing the number of clinical trials conducted among children. However, neonatal clinical trials account for only a small percentage of these trials. Performing neonatal clinical trials has many obstacles in terms of not only ethical and technical issues, but also the specific metabolic and physiological characteristics of neonates. Nevertheless, neonatal clinical trials are definitely needed to assure that safe and optimal evidence-based-therapies are applied in this special population.

키워드