• Title/Summary/Keyword: 임상 시험

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Invited Clinical Trials: Biocapital, Ethical Variability, and the Industrialization of Clinical Trial in Korea (초대받은 임상시험: 한국 임상시험 산업화 과정에서 생명자본(biocapital)과 윤리 가변성(ethical variability))

  • Song, Hwasun;Park, Buhm Soon
    • Journal of Science and Technology Studies
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    • v.18 no.3
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    • pp.1-45
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    • 2018

  • South Korea has recently emerged as one of the leading countries conducting clinical trials. Seoul, for instance, is now ranked at the top of the list among the cities in the world. This paper examines the rapid growth of research involving human subjects in Korea, not just from the economic perspective (e.g., the growth of global pharmaceutical markets and the subsequent increase in the demand for clinical trials), but from the policy perspective (e.g., the government?s drive to support and promote this field as a new industry). The industrialization of clinical trials in Korea has manifested itself in the rise of international Contract Research Organizations (CRO) doing their business in Korea. They are, figuratively speaking, invited to Korea by the government. This paper intends to uncover and discuss the bioethical issues concerning research on human subjects, the issues that tend to be set aside merely as procedural ones like ??workable documents??. To this end, it investigates the practice of clinical trials by collecting hitherto unherad voices from patient-volunteers, physician-researchers, CRO employees, and government officials. This paper also explores the themes of ??ethical variability?? and ??biocapital?? in order to compare and constrast the case in Korea with those in other countries.

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Comparison of the Perceptions between Investigators and Clinical Research Associates in Role Performances of Clinical Research Coordinators (임상연구코디네이터의 역할수행에 대한 연구자와 임상시험모니터요원의 인식비교)

  • Ko, Il-Sun;Hwang, Youn-Sun;Kim, Ho-Kon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.15 no.8
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    • pp.5095-5108
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    • 2014

  • The aim of this study was to compare the perceptions of the role performance of a clinical research coordinator (CRC) between the investigators and clinical research associates (CRAs). Data was collected using a structured questionnaire from 39 investigators and 68 CRAs in 4 hospitals from March 7 to November 30, 2011 and analyzed using descriptive statistics and a t-test. The investigators and CRAs were aware of the importance of CRC's role and they all gave the highest values for patients care management. On the other hand, the score of the role performance items showed perceptional differences between investigators and CRAs. Therefore, the development of detailed job descriptions and manuals will be needed to reduce the perceptional differences in the role performance of the CRC.

  • https://doi.org/10.5762/KAIS.2014.15.8.5095 인용 PDF KSCI

The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials (현재 국내임상시험에서 독립적 자료모니터링위원회의 필요성)

  • Kang, Seung-Ho
    • The Korean Journal of Applied Statistics
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    • v.22 no.2
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    • pp.317-327
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    • 2009

  • In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.

  • https://doi.org/10.5351/KJAS.2009.22.2.317 인용 PDF KSCI