How to Deal with a Temporary Suspension and Restarting Your Trial: Our Experiences and lessons Learnt

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. In this paper we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations and lessons that were learnt during the suspension that we are now applying in 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 learned. 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 our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.