With the European Union’s regulation on paediatric medicines providing pharmaceutical companies with new incentives to take up the slack in clinical trials specifically geared to children, a UK project is taking a look at how children are recruited into these trials.
The study, which will begin in September 2007, is being run under the National Health Service’s Health Technology Assessment (HTA) Programme by Dr Bridget Young, senior lecturer and director of communication skills in the University of Liverpool’s Department of Clinical Psychology. It will use four randomised controlled trials (RCTs) of paediatric medicines as the basis for a qualitative exploration of recruitment processes.
The aim is to improve both recruitment of children to clinical trials and the conduct of that recruitment. As the project outline notes, trialists “face considerable challenges in recruiting children and there are distinctive complexities surrounding RCTs involving child participants”.
Specifically, the study will examine how families and trial staff communicate during trial recruitment consultations. It will then explore the perspectives of all these through follow-up interviews. The project will include both families who agree to take part in a trial and those who decline.
While the study should provide evidence to assist trialists in improving recruitment of children, it will also address “the overriding requirement to ensure that children’s and parents’ decisions about participation are not unduly or inappropriately influenced”, the outline states. This requirement is particularly marked in paediatric RCTs, as “children are vulnerable and have special entitlements to protection”, it adds.
To this end, the study and its recommendations will be guided by a steering committee chaired by an independent expert in medical ethics and including representatives of key interest groups.