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

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。

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

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.