从管理视角探析研究者发起的口腔专业临床研究的问题与优化对策

Problem exploration and optimization method on the investigator-initiated trial in stomatology from the perspective of scientific research management

摘要

目的 促进口腔专业研究者发起的临床研究（investigator-initiated trail，IIT）的高质量设计与依规实施。 方法 结合工作实际，系统梳理口腔专业IIT的问题及其原因，通过查阅文献，从管理角度提出相应对策。 结果 口腔专业IIT存在着研究设计不规范、伦理审查和受试者保护意识不足、未依规开展研究注册与备案、不注重研究质量控制等问题。 结论 医疗机构应发挥IIT管理主体责任，结合口腔专业的特点，协同各类管理平台，建立流畅管理路径，加强科研人员和管理人员的双向培养，助力口腔医学发展。

Abstract

Objective To promote high quality design and implementation of Investigator-Initiated Trail (IIT) in stomatology. Methods Combining with the actual work, the problems and causes of IIT in stomatology were systematically sorted out, and the corresponding countermeasures were put forward from the perspective of management through literature review. Results There exist some problems in IIT in stomatology, such as lack of standardization in research design, insufficient ethical review and subject protection awareness, failure to conduct research registration and filing in accordance with regulations, lack of quality control. Conclusion Medical institutions should play the main responsibility of IIT management, collaborate with various management platforms and combine the characteristics of stomatology, establish smooth management paths, strengthen the two-way training of scientific researchers and management personnel to promoting the development of stomatology.

关键词

研究者发起的临床研究 / 常见问题 / 管理优化

Key words

investigator-initiated trial / problems / management optimization

基金资助

北京市医院管理中心创新梦工场经费资助(202330)