공익목적 임상연구 요양급여 적용 현황분석 및 개선방안

Abstract

The "Standards for the Application of National Health Insurance Benefits for Clinical Research" was implemented in May 2018 to cover the routine care costs of clinical research for public benefit, in order to expand treatment opportunities for new medical technologies in situations where patients have no alternative treatment options. Since the implementation, there has been a consensus on the significance and necessity of the project, but the consensus is still weak in terms of activation and advancement of the project. In this study, I identified the current situation by analyzing domestic and foreign clinical research support cases and data on applications and claims. I prepared improvement strategies for the clinical research medical benefits for public interest purposes based on the situation analysis and a collection of stakeholder opinions. The results of the domestic clinical research support system showed that the government and public institutions provide research funds and infrastructure for research related to rare, terminal, and severe diseases for which there is no alternative medical technology, and also consider aspects of research design to confirm clinical utility when selecting eligible clinical studies. A review of clinical research support systems in other countries shows that it is difficult to identify commonalities between the projects. The United States considers the therapeutic purpose, improvement of health outcomes, and appropriateness of the research design, while Japan applies health insurance based on the routine care cost for clinical research with licensing purposes. The United Kingdom and Australia determine support based on whether the research is commercial or non-commercial. As a result of checking the status of applications and claims, the proportion of investigator-initiated clinical studies is high, and the number of clinical studies applying for clinical research medical benefits has been increasing overall. The approval rate of sponsor-initiated clinical studies reviewed by the committee was less than 50%, and there were cases where the sponsor was a non-profit organization or a national research and development project. The results of the stakeholder and expert interviews were mixed, depending on the characteristics and interests of the subjects. Considering the purpose of the system and the status reviewed above, I propose improvements to the system for the purpose of fostering the application of clinical research medical benefits for public interest and rationalizing the application and management standards. Firstly, the application criteria and other systems should be improved in order to expand the number of clinical studies covered by routine care costs and increase the predictability of the review results. Second, to reduce the involvement of for-profit organizations in clinical research outcomes, efforts should be made to expand health insurance coverage of routine care costs as well as long-term support for research and infrastructure through public funds. Finally, it is necessary to establish an infrastructure to manage domestic clinical research from approval by the Ministry of Food and Drug Safety to registration of research results and to identify the status of clinical research so that mid- to long-term planning can be made.