Patient recruitment in paediatric clinical trials

Abstract

Trials in young people with diabetes are commonly perceived to be problematic because of participants' rejection of authority and issues with adherence. Attitudes were examined in patients aged 6–17 years (from the UK and Ireland) who had participated in a trial comparing insulin detemir (Levemir, Novo Nordisk, Denmark) with NPH in a multi-injection therapy for type 1 diabetes. Most patients needed to increase injection frequency (by at least one per day — usually at lunchtime, often at school), clinic attendance and glucose monitoring, and make multiple diary entries. A bespoke, 23-item, child-friendly questionnaire, which gave patients the option to remain anonymous to encourage honesty, was distributed to 44 patients. Of these, 36 completed the questionnaire: 58% aged 12–14, 25% aged 15–17, and 17% aged 6–11 years. The most popular reasons for trial entry were desire to improve glycaemic control (30%), ‘interesting prospect’ (21%) and a desire to help others (19%). Only 9% entered because of parental persuasion; 86% scored increased injection frequency and frequent visits positively, and 81% reported that they would participate in another trial if asked. Notwithstanding the possible self-selecting nature of this small cohort, experience of trial involvement was positive, implying that patients of all ages can be motivated to participate in trials to learn and help others, and they appreciate the inclusion of new technology, information supplied and additional support given by site staff. Copyright © 2005 John Wiley & Sons, Ltd.