文章摘要
重大突发公共卫生事件一级响应下三级医院临床试验开展情况调查分析
Conduct of clinical trials under primary response to major public health emergencies in tertiary hospital
  
DOI:10.3760/cma.j.cn113565-20200306-00076
中文关键词: 重大突发公共卫生事件  临床试验  应急预案  访视说明
英文关键词: Major public health emergencies  Clinical trial  Contingency
基金项目:
作者单位
于玲玲 北京医院科研处 国家老年医学中心 中国医学科学院老年医学研究院 
摘要点击次数: 255
中文摘要:
      目的 了解重大突发公共卫生事件(新型冠状病毒肺炎疫情)一级响应下三级医院临床试验开展情况。方法 采用电子调查问卷对三级医院通过伦理审查、尚未完成招募或未完成受试者出组的临床试验项目进行调查,调查内容包括项目基本信息,疫情期间临床试验项目采取的措施及常见问题处置情况。结果 共回收调查问卷198份,包含尚未招募受试者项目92项,已招募受试者项目106项。其中,59.15%暂未启动项目决定暂缓启动,76.19%暂未招募受试者项目决定暂缓招募。36.87%项目制定了疫情期间应急预案等文件。对于已经招募受试者的项目,5.66%的项目延长了访视时间窗,61.32%的项目对受试者进行远程访视,51.89%的项目进行远程治疗指导,51.89%的项目允许在就近医院完成实验室或影像学检查。38.68%的项目在保障运输条件下为受试者邮寄药物。对于需要到医院随访的项目,92%的项目会了解疫区接触史及现场监测体温。对于疫情期间出现的访视延迟,46.97%的项目按照违背方案上报,6.07%的项目不按照或者不确定是否按照违背方案上报。结论 申办方及医疗机构遵守疫情防护基本原则并因地制宜采取相应的措施,注重对受试者的保护,大部分临床试验遵从临床试验质量管理规范和伦理原则,尽可能保证临床试验规范有效地开展。
英文摘要:
      Objective Understand the status of clinical trials under primary response to major public health emergencies (COVID 19 epidemic) in tertiary hospital. Methods The electronic questionnaire was used to collect information of clinical trials, including these have been approved by ethical committee,still in the recruiting process or in the following up of enrolled human subject. The questionnaire included basic information, measures adopted by the trials and experiences for dealing with the common problems associated conducting clinical trials during the pandemic. Results A total of 198 questionnaires were returned, including 92 trials that have not yet recruited subjects and 106 trails that have recruited subjects. 59.15% of clinical trials that haven’t been initiated decide to postpone the starting date and 76.19% of clinical trials that haven’t recruited subjects decided to postpone subject recruitment. 36.87% of clinical trials made contingency plan or other similar documents. For those trials that have started to recruit subjects, 5.66% clinical trials prolonged follow up time window, 61.32% of clinical trials followed up subjects and 51.89% of clinical trials provided instructions to subjects through remote technology, 51.89% of clinical trials allowed subjects to do lab tests in nearby hospitals. 38.68% clinical trials mailed drugs to subjects under guaranteed transportation conditions. For clinical trials that required subjects come to hospital to follow up, 92% of clinical trials will check whether subjects had been to high risk area and measure body temperature when follow up. For clinical trials involving delayed follow up, 46.97% of clinical trials would recorded and reported protocol deviation,6.07% of clinical trials would not report or have not yet decided whether to report protocol deviation. Conclusions Sponsors and hospitals conducting clinical trials abide by the basic principles of epidemic prevention and take corresponding measures according to local conducting, focusing on the protection of subjects. Most clinical trials comply with the Good Clinical Practice and ethical principles to ensure that clinical trial were carried out as effectively as possible.
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