Background
antiseizure, epilepsy
CASTLE, RECRUITMENT, EPILEPSY, EPILEPSY
Randomised controlled trials (RCT) provide the best quality evidence for comparative effectiveness in medicine [As with other paediatric clinical trials, researchers undertaking paediatric epilepsy clinical trials face a range of challenges [The purpose of this paper is to reflect critically upon the factors which impacted recruitment to the pilot phase of the CASTLE (Changing Agendas in Sleep, Treatment and Learning in Epilepsy) RCT examining the effectiveness of two antiseizure medications (ASMs) and a sleep behaviour intervention (details below). We were aware that issues such as randomisation, equipoise, treatment, and other aspects of and parent and/or and patient preference [This paper will consider the processes which were established within the trial to support recruitment processes in the pilot CASTLE study, including our public and patient involvement and engagement (PPIE) work, the comprehensive training that underpinned site induction and our oversight of recruitment targets and figures. The paper will then report on the actions taken by the trial team to help us understand why we failed to recruit sufficient children to continue to the substantive trial phase. We reflect on the lessons learned and discuss the implications for paediatric clinical trials.