How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt.

ABSTRACT: 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 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 t

SUBMITTER: Constable L 

PROVIDER: S-EPMC7474317 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature