重大突发公共卫生事件下药物临床试验管理对策

Countermeasures for drug clinical trial management under major public health emergencies

本文拟通过针对疫情防控所采取的措施及临床试验质量保证的角度,探讨重大突发公共卫生事件下药物临床试验的管理对策。面对重大突发公共卫生事件,临床试验机构应根据相关规定采取防控措施,伦理委员会、研究者、申办者也要尽可能利用各种渠道减少对试验质量的影响。重大突发公共卫生事件是对药物临床试验机构应急能力的挑战。相关从业人员需转换思维模式,推进各方合作,全面提升管理能力。

The management strategies for drug clinical trials under major public health emergencies were discussed from the perspectives of measures taken for epidemic prevention and control as well as clinical trial quality assurance.Facing major public health emergencies,clinical trial institutions should take preventive and control measures in accordance with relevant regulations.It was necessary for ethics committees,investigators and sponsors to take use of any approaches to minimize the impact on trial quality.A major public health emergency is the challenge to emergency response capability for drug clinical trial institutions.Relevant practitioners need to promote cooperation among all parties by transforming their thinking modes so as to improve comprehensive management skills.