Analysis of compliance issues and management countermeasures of medical insurance fund in clinical research / 中华医学科研管理杂志

ABSTRACT

Objective:Clinical research is widely carried out in medical institutions, and there are differences in the use of research and conventional medical funds. This paper aimed to analyze the compliance issues of insurance fund in clinical research and explore the management strategies in the institutions conducting clinical trials or research.Methods:By consulting the literature, questionnaire, and work practice, this paper analyzed the current situation and existing problems of the compliance of the medical insurance fund in domestic clinical trials, proposed targeted management measures for the use of funds, and standardizes the corresponding workflow.Results:This paper summarized three payment methods of research-related funds and analyzed the main problems at present, including the definition of trial requirements, the payment of combined drugs specified in the protocol, the particularity of medical device trials, the payment of adverse events in clinical trial, the insurance of post-marketing research and clinical trial. According to the regulatory requirements and work practices, the corresponding management countermeasures were sorted out, including that the project funds and insurance audit should be carried out inside the medical institution. Clinical research, medical insurance management departments, ethics committees, and other departments should collaborate on establishing and improving a compliance management system. The research team should strengthen the management of adverse events, strengthen the publicity and education of the participants, and make good use of the sharing platform.Conclusions:The research institution should establish standardized and feasible processes, the research team should strengthen the management, and the use of the sharing platform is conducive to ensuring the compliance of the medical insurance fund and protecting the interests of the participants.