Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. Researchers working in the Centre for Healthcare Randomised Trials (CHaRT) have recently published a paper that describes the temporary suspension of a trial because of safety concerns. They also describe the challenges, considerations, and lessons learnt during the suspension that they, and other members of CHaRT, have applied during the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.
There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.
Based on their experience of managing a temporary suspension, they developed an action plan and guidance for managing a significant trial event, such as a temporary suspension. They have used this document to help manage the suspension of activities within CHaRT’s portfolio of trials during the current COVID-19 pandemic.
The full publication is available here – https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04705-4