重大疫情下口腔科临床试验管理策略和防控建议

新型冠状病毒肺炎疫情波及全球，受疫情影响大量的临床试验工作处于暂停、延缓状态，各地临床试验机构纷纷启动一系列应急管理措施。口腔科临床试验中各种检查需医患近距离接触，操作时易产生飞沫和气溶胶，有较高的交叉感染风险。此次疫情对口腔专业临床试验的运行带来巨大挑战。本文根据疫情防控要求和重大突发公共卫生事件下的临床试验管理共识，结合本机构相关工作指引和临床试验相关法规，对疫情下口腔科临床试验运行管理及临床试验过程中防护措施提出建议。旨在为疫情防控期间口腔科临床试验管理人员、研究者及受试者提供帮助。

Management strategies and suggestions on stomatological clinical trials under the influence of epidemic

Since the outbreak of Coronavirus Disease 2019 (COVID-19), a large number of clinical trials affected by the epidemic are suspended and postponed, and clinical trial institutions have initiated a series of emergency management measures. The characteristics of the diagnosis and treatment of stomatology are that the doctors and patients are closed to each other face to face, it is easy to produce droplets and aerosols, and there are many invasive operations, which leads to high risk of cross infection. The epidemic of COVID-19 poses a huge challenge to the operation of stomatological clinical trials. This paper based on the epidemic prevention and control requirements and the consensus on clinical trial management under major public health emergencies, combined with the relevant work guidelines of the institution and the relevant clinical trial regulations, puts forward suggestions on the clinical trial operation management and protective measures during the epidemic period. It may be helpful to the stomatological clinical trial researchers and subjects during the period of COVID-19.