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KMID : 1040120150010010024
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Evidence and Values in Healthcare
2015 Volume.1 No. 1 p.24 ~ p.34
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Development of clinical research support system for conditional coverage with evidence development
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Lee Min-Jin
Lee Na-Rae
Son Soo-Kyung
Lim Sung-Won
Rhee Jin-Nie
Yun Ji-Eun
Oh Eun-Hwan
Park Dong-Ah
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Abstract
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Objectives: The aim of this study was to propose a model of clinical research support system for conditional coverage with evidence development.
Methods: The main methods were web searches, literature review, and in-depth interviews with experts.
Results: Criteria for selecting the target technology, process administration, and funding criteria need to be developed to establish evidence development for conditional coverage through clinical research. 1) With respect to the selection criteria, the technologies that need additional evidence due to the lack of evidence for safety and effectiveness, medical technologies with a high potential of being able to obtain evidence within a short period, and those with generalized criteria due to a lack of evidence should be considered a priority. 2) In the process administration, an independent and professional agency should manage clinical research processes, provide scientific advice, and require activities to provide methodological guidance. It is necessary to construct related infrastructure and provide a performance system. 3) To smoothly operate a clinical research support system for conditional coverage with evidence development, funding issues are key factors to consider. Principally, it is reasonable that the government should fund the study as it is in accordance with government policy support. Additionally, various funding sources are necessary in terms of system sustainability.
Conclusion: In order to increase the credibility of evidence obtained through clinical research, the importance of process management must be acknowledged. Since the proposed scheme did not collect the various opinions, the policy should be designed through the consultation of stakeholders and agencies related to the actual system performed by authorities
and the targeted medical technology.
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KEYWORD
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Selective reimbursement, Conditional coverage, Evidence development, Research support system, Process management
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