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

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.

Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents

“…Prior research has reported various strategies to ensure the continuation and/or resumption of non-COVID-19 trials during the pandemic [6,7]. As these reports have been restricted in scope to pharmacological interventions and HIC perspectives, they may have limited utility to trialists testing psychological interventions in lowresource settings where trial conduct is substantially more challenging [21,22].…”

“…Around the world, non-COVID-19 clinical trials have been suspended or halted due to COVID-19 regulations, sponsor or funder directives and operational challenges [3][4][5]. Non-COVID-19 trials permitted to continue or resume and required substantial adjustments to recruitment, intervention, data collection and trial management protocols in response to the social distancing and quarantine challenges posed by COVID-19 [6,7]. Recent systematic reviews and studies have reported that these mitigation efforts have resulted in enrolment delays and operational gaps that have negatively impacted on trial timelines and outcomes [8,9].…”

“…To help operationalise this guidance, trialists are sharing their strategies for mitigating against COVID-19 challenges to trial conduct. These challenges include restricted access to health services, difficulty in recruiting participants due to stay-at-home orders, concern that trial procedures increase the risk of COVID-19 exposure for participants and staff, higher attrition rates due to difficulties in contacting participants and logistical challenges related to access to personal protective equipment (PPE) [6,7,[14][15][16][17][18]. While helpful, the literature remains largely limited to trials conducted in highincome countries (HICs).…”

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

“…In the midst of all the unknowns in a global pandemic, these safety decisions were often incredibly complicated. Many clinical trial populations still desperately needed treatment options; however, these same populations were often also be at higher risk for serious complications from COVID-19 infection [ 4 , 7 ].…”

“…Testing laboratories were also operating with diminished workforces. Entirely new ways of working have been developed as organizations moved to virtual platforms [ 4 ]. The operation of the bioanalytical laboratory was disrupted.…”