摘要
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.
作者
黄晓璇
王梅
HUANG Xiao-xuan;WANG Mei(Shandong Provincial Hospital Affiliated to Shandong First Medical University,Jinan 250021,China)
出处
《食品与药品》
CAS
2024年第4期371-374,共4页
Food and Drug
关键词
特医食品
临床试验
特定全营养配方食品
质量管理
food for special medical purpose(FSMP)
clinical trial
total nutritional formula food for use in special diseases
quality management
作者简介
黄晓璇,硕士,主要从事药物临床试验工作,E-mail:huangxx89@163.com;通讯作者:王梅,硕士,主要从事药物临床试验管理工作,E-mail:shiyanjigouban@126.com。
