Presenting a case for involving children with a terminal illness in clinical trials

Today's approaches to the treatment of childhood malignancies are the result of past clinical trials. In order to improve survival it is essential we continue to seek benefit from clinical trials. However, entry of terminally ill children into a phase I or phase II clinical trial, involving a novel, potentially therapeutic, agent is highly contentious. This article will argue in favour of a child's active and full participation in the decision to enter into a phase I or phase II clinical trial. A formal study of the role of children in clinical trials, especially phase I and phase II trials, is urgently required if standards of best practice are to be laid down and subsequently measured.