• Title, Summary, Keyword: 임상시험

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칼슘차단제의 시판후 조사

  • Kim Yeong-Sik;Jo Hong-Jun;Choi Hyeon-Rim;Seo Hong-Gwan;Sin Ho-Cheol;Park Eun-Suk;Yang Yun-Jun;Kim Yeong-Ju;Jo Gyeong-Hwan;Lee Sin-Hwi;Jeong Seung-Pil;Lee Jeong-Gwon;An Yun-Ok
    • 대한임상약리학회:학술대회논문집
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    • pp.41-41
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    • 1993
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의약품 시판 후 조사의 연구방법 개발에 관한 연구 - Angiotensin 전환효소 억제제의 부작용을 중심으로-

  • 김영식;조홍준;송윤미;서홍관;최현림;서학은;김영주;신호철;박은숙
    • Proceedings of the Korean Society of Applied Pharmacology
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    • pp.94-94
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    • 1993
  • Angiotensin 전환효소 억제제를 재료로하여 다기관 협동을 통한 시판 후 조사방법론을 개발하고, 아울러 Angiotensin 전환효소 억제제 투여시 나타나는 기침의 발생율과 이와 관련된 요인을 밝히고자 시판 후 조사를 시도하였다. 방법: 1992년 2월부터 1992년 10월까지 11개 병원 가정의학과를 방문하여 Angiotensin 전환효소 억제제를 투여한 고혈압 환자 348명을 연구대상으로 하였다. 이중 남자가 147명, 여자가 201명이었으며, 연령별로는 39세이하 38명, 40-54세 156명, 55세 이상이 154명이었다. 최초 약물투여 후 2, 4, 8, 12주에 추적 관찰하였으며, 기침의 발생율은 PC-SAS 6.04를 이용하여 Kaplan-Meier 방법과 Log-Rank 방법으로 분석하였다.

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임상시험 Guideline(총론)

  • 노재경
    • Proceedings of the Korean Society of Applied Pharmacology
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    • pp.5-8
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    • 1994
  • 임상시험 guideline은 신약개발을 촉진하기 위하여 약사법 제 26조 제 6항 및 제 24조 제 8호의 규정에 의거하여 신약 임상시험의 안내서로 활용하게 하는데 있다. 임상시험은 특정약의 특정 질환에 대한 임상효과를 판정하기 위하여 시험약의 효과 및 부작용을 윤리적으로 타당한 과학적 시험을 통하여 시행하는 것이다. 특히 임상시험은 사람을 대상으로 하기 때문에 윤리적이고 과학적인 방법을 통하여 시행착오를 최소화하고, 피험자가 위험에 처할 가능성을 최소화하여야 한다.

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Current State and Applications of the Electronic Clinical Trial Process in Korea (국내 임상시험 전자화 현황과 적용방안)

  • Wang, Boram;Choi, Inyoung
    • The Journal of the Korea Contents Association
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    • v.13 no.4
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    • pp.281-289
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    • 2013
  • As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

A Study on the Job Satisfaction of Nurses Experiencing Clinical and Clinical Trials (임상과 임상시험을 경험한 간호사의 직무만족에 관한 연구)

  • Kang, Cheon-Kook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.1
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    • pp.604-611
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    • 2020
  • This study was undertaken is to improve the working conditions by improving the job satisfaction of clinical research nurses and clinical nurses involved in and conducting clinical trials. The survey was conducted from November 6 to December 6, 2017 for 100 nurses working in Seoul and Gyeonggi-do. The accumulated data were analyzed by frequency analysis, reliability verification, and t-test using the SPSS program. Our results reveal that job satisfaction was higher for clinical nurses (2.94 ± 0.609 points) as compared to clinical research nurses (2.89 ± 0.620 points). Also, the satisfaction level of salary received was higher amongst the clinical nurses than the clinical research nurses. Furthermore, although career decision was relatively lower for the clinical nurse than the clinical research nurse, the importance of job performance and job stability ranked high. Considering importance of the role of clinical research nurses in clinical trials, it is necessary to enhance their job satisfaction by improving the clinical trial environment such as appropriate treatment and professional role, and the working environment including remuneration, professional status, and administrative work to establish their jobs.

임상시험연구의 통계적 고찰

  • 박미라;이재원
    • Communications for Statistical Applications and Methods
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    • v.2 no.1
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    • pp.229-247
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    • 1995
  • 신뢰할만한 임상시험연구결과를 얻기 위해서는 통계학자가 임상시험연구의 준비단계에서부터 실험계획 및 연구의 운용, 분석은 물론 결과의 보고에 이르기까지 총체적으로 관여해야 한다. 의학전문가들과의 원활한 공동연구를 위해서는 통계학자들이 의학분야에서의 용어나 관례, 임상시험이 이루어지는 절차등에 대한 명확한 이해가 필요하게 된다. 이 논문에서는 임상시험에서 진행되는 제반문제에 대해 통계학자가 숙지해야 할 사항들에 대해 논의 하였다.

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Effect Analysis of Electronic Clinical Trial Systems (효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석)

  • Lee, Hyun-Ju;Choi, In-Young
    • The Journal of the Korea Contents Association
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    • v.11 no.1
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    • pp.350-356
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    • 2011
  • The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.