Managing clinical trials during COVID-19: experience from a clinical research facility

Trials

Frances Shiely¹  Shaunagh Browne¹  Maeve Kelsey¹  Amy Stone¹  Ellen Murphy¹  Joanne Walsh-Crowley¹  Joseph A. Eustace¹  Jean Foley¹  Emma Cobbe¹ 

[1] Trials Research and Methodologies Unit, HRB Clinical Research Facility at University College Cork, Mercy University Hospital;

关键词: Trial management;    Pandemic;    Clinical trials;    Participant safety;    COVID-19;   

DOI  :  10.1186/s13063-020-05004-8

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown