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| 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 |
| 投稿时间：2020-03-06 修订日期：2020-03-26 |
| DOI： |
| 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 plan Follow-up instruction |
| 基金项目: |
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| 摘要点击次数: 126 |
| 中文摘要: |
| 目的 了解重大突发公共卫生事件（新冠肺炎疫情）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。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 %项目延长了访视时间窗，61.32%项目对受试者进行远程访视，51.89%项目进行远程治疗指导，51.89%项目允许在就近医院完成实验室或影像学检查。38.68%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%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%项目按照违背方案上报，6.07%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开展。 |
| 英文摘要: |
| Objective Understand the conduct of clinical trials under primary response to major public health emergencies (COVID-19 epidemic) in tertiary hospital. Methods The electronic questionnaire was used to investigate clinical trial projects in tertiary hospital which have been approved by ethical committee，plan to recruit subjects or subjects haven’t finished follow-up. The questionnaire included basic information, measures to be taken to clinical trials and how to deal with the common problems associated clinical trials during epidemic?situation. Results The total number of returned questionnaire was 198 including 92 clinical trials haven’t recruited subjects and 106 have recruited subjects. 59.15% of clinical trials that haven’t been initiated decide to delay start and 76.19% of clinical trials that haven’t recruited subjects decided to delay?subject recruitment. 36.87% of clinical trials made contingency plan or other similar documents. During clinical trials that have recruited 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 related tests in nearby hospitals. 38.68% clinical trials mailed drugs to subjects under guaranteed transportation conditions. For clinical trials that required subjects to hospital to follow up, 92% of clinical trials will check whether subjects had gone to epidemic 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 wouldn’t report or haven’t decided whether to report protocol deviation. Conclusions Sponsors and hospitals conducted clinical trial under principle of epidemic protection and adjusted measures to current conditions. More attentions were payed to protect clinical trial subjects. Most clinical trials followed principles of Good Clinical Practice and ethics and ensure good and effective conduct of clinical trial as far as possible. |
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