上海口腔医学

上海口腔医学 ›› 2020, Vol. 29 ›› Issue (2): 113-117.doi: 10.19439/j.sjos.2020.02.001

• 新冠肺炎专栏 • 上一篇    下一篇

重大突发公共卫生事件一级响应下口腔疾病临床研究工作指导建议

黄铖1*, 石超吉1*, 许锋2, 甄红2, 陈茹1, 陆海霞1#, 张志愿1#   

  1. 1.上海交通大学医学院附属第九人民医院·口腔医学院,国家口腔疾病临床医学研究中心,上海市口腔医学重点实验室,上海市口腔医学研究所,上海 200011;
    2.上海交通大学医学院附属第九人民医院 临床研究中心,上海 200011
  • 收稿日期:2020-02-21 修回日期:2020-02-22 出版日期:2020-04-25 发布日期:2020-04-30
  • 通讯作者: 张志愿,E-mail:zhzhy0502@163.com;陆海霞,E-mail:ritalu0225@hotmail.com。#共同通信作者
  • 作者简介:黄铖(1993-),女,硕士,E-mail:dengdeng_1993@126.com;石超吉(1988-),男,硕士,E-mail:scjtdcq@126.com。*并列第一作者
  • 基金资助:
    上海市重中之重临床医学中心(2017ZZ01011);上海市临床重点专科建设项目(shslczdzk01601);上海市口腔疾病临床医学研究中心科研资助项目(19MC1910600)

Instructions for clinical research of oral diseases under the first level response to public health emergencies

HUANG Cheng1, SHI Chao-ji1, XU Feng2, ZHEN Hong2, CHEN Ru1, LU Hai-xia1, ZHANG Zhi-yuan1   

  1. 1.National Clinical Research Center for Oral Diseases, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology. Shanghai 200011;
    2.Clinical Research Center, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Shanghai 200011, China
  • Received:2020-02-21 Revised:2020-02-22 Online:2020-04-25 Published:2020-04-30

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摘要： 新型冠状病毒肺炎(corona virus disease 2019,COVID-19)疫情发展迅速,各地相继启动突发公共卫生事件一级响应。新型冠状病毒肺炎的爆发,对包括口腔疾病在内的临床研究的开展带来了巨大挑战。鉴于口腔疾病专业特点与诊疗操作的特殊性,保障临床研究受试者和相关从业人员的健康与权益、规范临床研究的实施尤为必要。结合国家卫生健康委员会颁发的相关规范标准,并参考部分临床研究相关组织发布的临床试验管理共识和中华口腔医学会制定的疫情期间口腔疾病治疗规范,特制订口腔疾病临床研究工作指导建议,为重大突发公共卫生事件一级响应下口腔疾病临床研究的开展提供参考。

关键词: 新型冠状病毒肺炎, 突发公共卫生事件, 口腔疾病, 临床研究

Abstract: Corona virus disease 2019(COVID-19) has swept across our country and local governments have successively initiated first level response to public health emergencies. The outbreak of COVID-19 poses a huge challenge to the implementation of various clinical researches including oral diseases. In view of the specialty of oral diseases, it is particularly necessary to protect the health and rights of the participators and related practitioners, and to standardize the implementation of clinical trials. Based on the normative standards issued by the National Health Commission of China, consensus on clinical trial management formulated by the organization of clinical research, and regulations for the diagnosis and treatment of oral diseases during public health emergencies by Chinese Stomatological Association, we drafted the guideline for clinical research of oral diseases, with a view to provide reference for the clinical studies of oral diseases under the first level response to major public health emergencies.

Key words: COVID-19, Public health emergencies, Oral diseases, Clinical research

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