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The system development of clinical study for conditional coverage with evidence generation

PUBLISH DATE 2015.03.31
FILE [Executive Summary] The system development of clinical study for conditional coverage with evidence generation.pdf

Summary

The government has introduced 'selective reimbursement system' by targeting the entry with the social demands though uncertain effectiveness. If it is determined as a selective reimbursement item, that technology is covered under national health insurance with differentiated patient payment. There has been a demand for a review system that can support clinical research and research process management even for health technologies covered by health insurance and in cases requiring evidence development for medical treatments that determine that there are uncertainties in evidence for treatment effectiveness. Therefore, this study was to examine the general system that supports clinical research on health technologies that require evidence development as one of the ways for conditional coverage and as a target for selective reimbursement. Finally, we developed process management modes and detailed procedures for clinical research processes appropriate to domestic conditions.


The aim of this study is to suggest a general model and related detailed procedures for clinical research support for evidence generation for domestic conditional coverage as well as policy support measures.

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