Love Sharon B, Armstrong Emma, Bayliss Carrie, Boulter Melanie, Fox Lisa, Grumett Joanne, Rafferty Patricia, Temesi Barbara, Wills Krista, Corkhill Andrea
MRC Clinical Trials Unit at UCL, 90 High Holborn, WC1V 6LJ, London, UK.
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Trials. 2021 Apr 14;22(1):279. doi: 10.1186/s13063-021-05225-5.
The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring.Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.
新冠疫情影响了临床试验的管理方式，这在现有项目组合以及快速开展的新冠临床试验中均有体现。由于全国感染风险导致工作人员和公众行动受限、研究人员转至临床岗位使得临床工作人员资源减少，以及工作人员居家办公导致申办方和申办方代表的工作安排发生变化，负责监督试验的申办方或受托组织需要考虑并采用其他工作方式。各组织通常各自为政，以快速推进疫情期间开展临床试验所需的缓解措施；本文介绍了来自英国临床研究协作组织（UKCRC）临床试验单位（CTU）的一组监查负责人的诸多经验教训。由9个CTU的监查负责人组成的UKCRC监查任务与完成小组多次开会，以确定新冠疫情如何影响临床试验监查。知情同意作为本文中的一个具体问题被纳入，因为在试验监查计划（TMP）中通常需要审查已完成的同意文件。监查被定义为包括现场监查、集中监查或/和远程监查。为保护患者安全和试验完整性并确保方案得到遵循而进行的监查，通常最好通过集中、远程和现场监查相结合的方式来完成。然而，如果无法进行现场监查，仅使用集中监查或集中与远程监查相结合的方式也能找到可行的解决方案。电子知情同意、由第三方同意或通过远程方式同意都是可行的。将数据集精简至关键数据可减少研究点和CTU工作人员的工作量。新冠疫情导致的居家办公使电子试验主文件（TMF）更具吸引力。允许研究点在方便的时间预约并参加方案培训已取得成功，未来对于有多个研究点的试验而言值得推行。新冠疫情在英国的出现促使人们思考并改变临床试验监查的开展方式。一些已形成的做法在其他疫情中会有用，而其他一些做法应纳入常规使用。
