신생아 임상 연구의 현황과 필요성
Current Status and Importance of Clinical Research Involving Neonates
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Clinical trials in neonates of different gestational age, birth weight, postnatal age and general health status are needed to assure safe and optimal evidence-based-therapy to this special population. Pharmacodynamic maturation must be considered in grouping the neonates for clinical trials. Informed consent from the parents, protection of the neonates participating in the clinical trials, adherence to good clinical practice guidelines, and designation of short term and long term outcomes must be taken into consideration from the beginning of the trials. Collaboration between centers will be helpful in overcoming the problem with small patient size. Many of these challenges are surmountable and an well-designed clinical trial will improve the mortality and morbidity in these very small children. (J Korean Soc Neonatol 2008;15:113-118)
Abstract
Clinical trials in neonates of different gestational age, birth weight, postnatal age and general health status are needed to assure safe and optimal evidence-based-therapy to this special population. Pharmacodynamic maturation must be considered in grouping the neonates for clinical trials. Informed consent from the parents, protection of the neonates participating in the clinical trials, adherence to good clinical practice guidelines, and designation of short term and long term outcomes must be taken into consideration from the beginning of the trials. Collaboration between centers will be helpful in overcoming the problem with small patient size. Many of these challenges are surmountable and an well-designed clinical trial will improve the mortality and morbidity in these very small children. (J Korean Soc Neonatol 2008;15:113-118)
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