Sheung-Nyoung Choi1, Ji-Hyun Lee1, In-Kyung Song1, Eun-Hee Kim1, Jin-Tae Kim1, Hee-Soo Kim2. 1. Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, 03080, Seoul, Republic of Korea. 2. Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, #101 Daehak-ro, Jongno-gu, 03080, Seoul, Republic of Korea. dami0605@snu.ac.kr.
Abstract
BACKGROUND: The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. OBJECTIVE: The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. METHODS: We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. RESULTS: We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. CONCLUSIONS: Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.
BACKGROUND: The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. OBJECTIVE: The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. METHODS: We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. RESULTS: We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. CONCLUSIONS: Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.
Authors: S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker Journal: BMJ Date: 2000-01-08
Authors: Tsiao Yi Yap; Amy D Yamokoski; Sabahat Hizlan; Stephen J Zyzanski; Anne L Angiolillo; Susan R Rheingold; Justin N Baker; Eric D Kodish Journal: Cancer Date: 2010-07-01 Impact factor: 6.860