Trials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital, Grenville Place, Cork, Ireland.
School of Public Health, University College Cork, Western Road, 4th Floor Western Gateway Building, Cork, Ireland.
Trials. 2021 Jan 18;22(1):62. doi: 10.1186/s13063-020-05004-8.
There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.
关于管理临床试验的最佳实践，相关文献匮乏，对于临床试验经理的角色也知之甚少。新冠疫情的爆发使这一点成为焦点，随着各国为控制病毒传播而进入封锁状态，全球临床试验的继续进行陷入了不确定状态。在临床试验中，参与者的保留率一直是一个问题，人们担心在当前的大流行环境下，人员流失将成为一个潜在的问题，有可能危及试验的完成。目前的情况需要试验经理及时解决问题，以确保试验继续进行，最重要的是，要监测临床试验中至关重要的参与者安全。我们的研究目的是从管理学术和商业临床试验的临床研究机构的第一手经验中，强调在大流行期间管理临床试验时出现的关键问题。我们提供了一些关于解决方案实施的实用指导。
