特医食品临床试验的现状及发展建议

Present Situation and Development Suggestion of Clinical Trials of Food for Special Medical Purpose

本文分别从医疗机构备案情况、特定全营养配方食品研发、方案设计与科学性保障、机构管理与伦理审查、受试者依从性管理、研究团队能力构建与协同合作共六方面,全面分析特医食品临床试验的实施现状,并对我国特医食品临床试验的发展提出建议。

The implementation status of clinical trials of food for special medical purpose(FSMP) are analyzed comprehensively in this paper from six aspects,namely,the filing status of medical institutions,the research and development of total nutritional formula food for use in special diseases,protocol design and scientific assurance,institutional management and ethical review,subject compliance management and capacity building and collaborative cooperation of research team.Suggestions on the development of clinical trials of FSMP are put forward.