Article type
Year
Abstract
Background: Since 2014, the Korean government has introduced Selective Reimbursement System to intensify national health coverage for severe diseases including cancer, cardiac, cerebrovascular, and rare diseases. Unfortunately, in most cases, available scientific evidence that can be used as an evidence-base for making policy decision is often limited.
Objectives: The purpose of this study was to suggest a model for a clinical research support system for conditional coverage with evidence development.
Methods: A search for relevant web pages, a quick literature review, and an in-depth interview with experts were performed for this study.
Results: Criteria for prioritization of target technologies, administration of research process, and funding source should be developed to establish evidence development for conditional coverage through clinical research. With respect to the prioritization, the technologies that need additional evidence due to uncertainty of safety and effectiveness and have a high potential of being able to obtain evidence within a short period should be proritized. In the administration of research process, an independent and professional agency including a ‘steering committee’ or ‘sub-committee’ that can provide scientific advice and methodological guidance should manage the clinical research processes. Funding issues are key factors to be considered carefully in order to settle the clinical research support system for conditional coverage with evidence development in smoothly. Principally, it is reasonable that the government should fund the study, as it is in accordance with government policy support. Additionally, various funding sources (e.g. research foundation etc) are necessary in terms of system sustainability.
Conclusions: To guarantee a high quality of evidence obtained through the clinical research, the importance of process management must be acknowledged. The actual policy should be designed through the consultation of stakeholders and agencies related to the system, roles that should be performed by authorities and the targeted technology.
Objectives: The purpose of this study was to suggest a model for a clinical research support system for conditional coverage with evidence development.
Methods: A search for relevant web pages, a quick literature review, and an in-depth interview with experts were performed for this study.
Results: Criteria for prioritization of target technologies, administration of research process, and funding source should be developed to establish evidence development for conditional coverage through clinical research. With respect to the prioritization, the technologies that need additional evidence due to uncertainty of safety and effectiveness and have a high potential of being able to obtain evidence within a short period should be proritized. In the administration of research process, an independent and professional agency including a ‘steering committee’ or ‘sub-committee’ that can provide scientific advice and methodological guidance should manage the clinical research processes. Funding issues are key factors to be considered carefully in order to settle the clinical research support system for conditional coverage with evidence development in smoothly. Principally, it is reasonable that the government should fund the study, as it is in accordance with government policy support. Additionally, various funding sources (e.g. research foundation etc) are necessary in terms of system sustainability.
Conclusions: To guarantee a high quality of evidence obtained through the clinical research, the importance of process management must be acknowledged. The actual policy should be designed through the consultation of stakeholders and agencies related to the system, roles that should be performed by authorities and the targeted technology.