疫情时事：FDA发布临床试验指南

阿拉丁翻译苏琳

Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials

疫情时事：FDA发布临床试验指南

The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
美国食品药品监督管理局于3月18日发布了一项指南，以供在新冠病毒疫情期间进行临床试验的各行业人士、调查人员和伦理审查委员会参考。

The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19. The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. Although the impact of COVID-19 on trials will vary depending on many factors, including the nature of disease under study, the trial design and in what region(s) the study is being conducted, the FDA outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.
FDA认为新冠疫情可能会对医药产品（包括药物、设备和生物制品）的临床试验产生重大影响。例如，如果现场人员或试验受试者感染了SARS-CoV-2（引起新冠的病毒），随之带来的将是隔离、现场关闭、出行限制、试验产品供应链中断等一系列问题。FDA意识到需要对方案进行修改，并且由于新冠影响，可能会出现不可避免的偏差。新冠对试验的影响因许多因素而异，包括研究中疾病的性质、试验设计和研究进行的区域等。为协助发起人保障试验参与人员的安全，遵守药物临床试验质量管理规范，和最大化降低试验风险，FDA列出了几项考虑因素。建议的考虑因素包括，发起人评估测试替代方法，如电话联系或网络观测，以及为那些可能无法再使用试验药物或到达试验现场的试验参与者提供额外的安全监测。

“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”
FDA医学科学事务部副部长Anand Shah医学博士说：“FDA发布的这项指南旨在帮助行业人士和研究人员应对新冠疫情，协助评定如何推进关键临床试验。该项指南强调的重点是，无论在任何时候，患者的安全都是首要考虑因素。我们鼓励按照药物临床试验质量管理规范
继续进行此类临床试验，确保将试验风险降至最低，保障研究参与者的健康和福祉。”

yuanzhi780617

无论在任何时候，患者的安全都是首要考虑因素，说的好，因为我们一直这样做的，呵呵

AZER

安全性是前提

syhorchid

谢谢分享