It is unprecedented: trial management during the COVID-19 pandemic and beyond

Abstract

The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers’ Network (UKTMN), a national network of trial management professionals managing non-commercial trials. In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority. Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future.

The COVID-19 Pandemic Accelerated Publication of Medical Articles

“…Consequently, there are currently many challenges associated with conducting clinical trials. These challenges include di culties in registration as well as protocol treatment compliance due to the limited accessibility of participants and research staff [20,21]. These di culties may also lead to inadequate outcome data that is required to ful ll sponsors' logistical trial obligations.…”

“…The in uence of the COVID-19 pandemic on trends of published articles A further comparative analysis of the growth trend of medical research published in the last ve years showed that the total number of articles increased annually from 2015 to 2019. The average annual growth was 28,933(21,134). The total number of articles growth in 2020/2019 was 88,774.…”

Successful conduct of an acute stroke clinical trial during COVID

“…Inclusion criteria for enrollment into BEST-MSU are: last seen normal within 4.5 hours of symptom onset, history and neurological examination consistent with acute stroke, and no obvious contraindications for tPA. If patients meet these criteria, they are loaded onto the MSU, a CT head is performed along with NIHSS, vital signs, IV line placement and verification of history and exam for tPA exclusions using current published guidelines [ 2 ]. The imaging is read by the vascular neurologist.…”

“…As the COVID-19 pandemic reached the US in early 2020, measures were implemented by local authorities to control the infection’s spread and preserve regional hospital capability to deal with a surge in COVID cases. This included substantial attenuation of clinical research based on FDA recommendations and expert opinion [ 2 – 4 ]. At the community level, these included “stay-at-home”, social distancing, and mask regulations.…”

Paediatric research in the times of COVID-19

“…Research training and governance can certainly be better targeted in a risk-appropriate way, with more resource and oversight for complex or higher-risk early phase trials and later phase trials more embedded in routine clinical care. 40 …”