Abstract：
BACKGROUND: This report describes the U.S. Food and Drug Administration (FDA) experience in establishing a dedicated mailbox, and in publishing related guidance, to address concerns among interested parties regarding the conduct of clinical trials during the COVID-19 public health emergency (PHE).
METHODS: Six hundred and thirty-four mailbox inquiries were received from March 2020 through February 2022. Qualitative methods were used to provide a structured description of, and identify common themes among, these inquiries.
RESULTS: Most inquiries came from U.S.-based interested parties, including sponsors, industry trade associations, academic institutions, hospitals, clinics, research sites, trial participants, and individual persons. Approximately one-fifth of questions were related directly to COVID-19 (e.g., proposals for treatment); other inquiries were related to conduct of routine trial-related activities, and concerns were often focused on maintaining compliance with good clinical practice. In March 2020, FDA published a guidance titled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; the document was subsequently revised eight times based in part on issues raised in mailbox inquiries.
CONCLUSIONS: The dedicated mailbox enabled expedited communication among invested parties during the COVID-19 PHE; FDA also provided updates of the aforementioned guidance. These efforts supported the continuance of ongoing trials and the initiation of new trials during the PHE in accordance with good clinical practice guidelines, thereby helping to ensure the safety of trial participants while maintaining the quality of trial data. By soliciting and responding to trial-related inquiries and addressing corresponding needs and concerns, FDA improved transparency and communication.
METHODS: Six hundred and thirty-four mailbox inquiries were received from March 2020 through February 2022. Qualitative methods were used to provide a structured description of, and identify common themes among, these inquiries.
RESULTS: Most inquiries came from U.S.-based interested parties, including sponsors, industry trade associations, academic institutions, hospitals, clinics, research sites, trial participants, and individual persons. Approximately one-fifth of questions were related directly to COVID-19 (e.g., proposals for treatment); other inquiries were related to conduct of routine trial-related activities, and concerns were often focused on maintaining compliance with good clinical practice. In March 2020, FDA published a guidance titled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; the document was subsequently revised eight times based in part on issues raised in mailbox inquiries.
CONCLUSIONS: The dedicated mailbox enabled expedited communication among invested parties during the COVID-19 PHE; FDA also provided updates of the aforementioned guidance. These efforts supported the continuance of ongoing trials and the initiation of new trials during the PHE in accordance with good clinical practice guidelines, thereby helping to ensure the safety of trial participants while maintaining the quality of trial data. By soliciting and responding to trial-related inquiries and addressing corresponding needs and concerns, FDA improved transparency and communication.
摘要：
背景：本报告描述了美国食品药品监督管理局（FDA）在建立专用邮箱方面的经验，在发布相关指南时，解决有关各方对COVID-19公共卫生紧急情况（PHE）期间进行临床试验的担忧。
方法：从2020年3月到2022年2月，收到了6134个邮箱查询。定性方法被用来提供一个结构化的描述，并确定共同的主题，这些询问。
结果：大多数查询来自美国的相关方，包括赞助商,行业行业协会，学术机构,医院,诊所,研究地点,试验参与者，和个人。大约五分之一的问题与COVID-19直接相关(例如，治疗建议)；其他询问与常规试验相关活动的开展有关，并且关注点通常集中在保持对良好临床实践的遵守上.2020年3月，FDA发布了题为“在COVID-19公共卫生紧急情况期间进行医疗产品临床试验”的指南；该文件随后进行了八次修订，部分是基于邮箱查询中提出的问题。
结论：在COVID-19PHE期间，专用邮箱使投资方之间能够进行快速沟通；FDA还提供了上述指南的更新。这些努力支持继续进行中的试验，并根据良好临床实践指南在PHE期间启动新的试验。从而有助于确保试验参与者的安全性，同时保持试验数据的质量。通过征求和回应与审判有关的询问，并解决相应的需求和关切，FDA提高了透明度和沟通。
方法：从2020年3月到2022年2月，收到了6134个邮箱查询。定性方法被用来提供一个结构化的描述，并确定共同的主题，这些询问。
结果：大多数查询来自美国的相关方，包括赞助商,行业行业协会，学术机构,医院,诊所,研究地点,试验参与者，和个人。大约五分之一的问题与COVID-19直接相关(例如，治疗建议)；其他询问与常规试验相关活动的开展有关，并且关注点通常集中在保持对良好临床实践的遵守上.2020年3月，FDA发布了题为“在COVID-19公共卫生紧急情况期间进行医疗产品临床试验”的指南；该文件随后进行了八次修订，部分是基于邮箱查询中提出的问题。
结论：在COVID-19PHE期间，专用邮箱使投资方之间能够进行快速沟通；FDA还提供了上述指南的更新。这些努力支持继续进行中的试验，并根据良好临床实践指南在PHE期间启动新的试验。从而有助于确保试验参与者的安全性，同时保持试验数据的质量。通过征求和回应与审判有关的询问，并解决相应的需求和关切，FDA提高了透明度和沟通。
