Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Current Adoption of Electronic Data Capture System in Clinical Trials and Future Direction

임상시험정보시스템 현황분석과 적용방안 모색

  • Jeong, Sun-Ok (Clinical Research Coordinating Center, Catholic Medical Center, Department of Preventive Medicine, College of Medicine The Catholic University) ;
  • Kwon, Su-Kyoung (Clinical Research Coordinating Center, Catholic Medical Center, Department of Preventive Medicine, College of Medicine The Catholic University) ;
  • Choi, In-Young (Clinical Research Coordinating Center, Catholic Medical Center, Department of Preventive Medicine, College of Medicine The Catholic University)
  • 정순옥 (가톨릭중앙의료원 임상연구지원센터, 가톨릭대학교 의과대학 예방의학교실) ;
  • 권수경 (가톨릭중앙의료원 임상연구지원센터, 가톨릭대학교 의과대학 예방의학교실) ;
  • 최인영 (가톨릭중앙의료원 임상연구지원센터, 가톨릭대학교 의과대학 예방의학교실)
  • Published : 2008.12.30

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Abstract

Background: Over the past decade, pharmaceutical companies have introduced a number of initiatives to boost the productivity of clinical trials. In clinical trials, this can take to reduce costs and durations of that are being considered in applying information technology. One of these initiatives has been the rollout of electronic data capture (EDC) systems, which allow patients and researcher to enter their trial information directly, either in electronic diaries or online systems. The utilization rate of the EDC in the United States is 41.5%, and similar trends can be seen in 40.5% in Japan. Objectives: Currently, the adoption of EDC in Korea is also getting increased, so the current status of EDC application should be assessed in clinical trials. The aim of this study was identified in present status of EDC system and to improvements to develop it. Method: The survey of participants has been accomplishment in a clinical research coordinator workshop and e-CRF System workshop, which was held in a University Hospital, located in Seoul. The main questionnaire items were 14 including the career of EDC system. Totally, 109 responses were classified by fields of clinical trials study, and comparison analyzed each questionnaire items. Result: The survey of participants has been separated pharmaceutical company participants (39.4%), contract research organization or clinical research associate participants (26%), investigator (research coordinator) (24%), and other participants (10.6%). Current EDC System applied Phase III(40.0%) and will plan to use of system Phase I(34.5%), Phase II(16.7%) Conclusion: EDC systems are increasingly applied for clinical trials and current status of EDC system was assessed in this study. To increase the adoption of the EDCs, the related regulations should be developed, and also decision makers need to understand the importance of information technology in clinical trials.

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