Early termination of clinical trials in paediatrics

Clinical trials are planned in phases to gather evidence, address specific aims and, ultimately, to assess whether a specific drug is efficacious in the patient group. This planning will usually include a protocol detailing the process from initial recruitment to post-trial drug access or follow up. However, when a clinical trial is terminated earlier than planned, this can result in less structured end-of-trial participation. This article looks at a range of international evidence to inform an at-a-glance review.

There are mixed reports on whether randomised controlled trials for children and young people are more or less likely to end prematurely (Schandelmaier et al, 2017; Dufetelle et al, 2018), which is confounded by a paucity of specific literature (Pica and Bourgeois, 2016; Schandelmaier et al, 2017). Owing to the dearth of evidence, and the international nature of paediatric clinical trials, research from around the world has been considered here.