RECRUITING PATIENTS TO CLINICAL-TRIALS - LESSONS FROM STUDIES OF GROWTH-HORMONE TREATMENT IN RENAL-FAILURE

Issues raised by the recruitment of children to trials of growth hormo ne treatment for short stature in chronic renal failure are reported. Information needs of parents and children are discussed, the latter sh ould take account of the children's developmental level and anticipate d involvement in decision making. When the incidence of certain side e ffects is low and probably unquantifiable there are particular problem s; failure to include these in information sheets may compromise infor med consent but inclusion will, at least for some families, make an al ready difficult decision even more complicated. A process of recruitme nt is described which attempts to protect against bias and which balan ces the requirement to impart neutral information with appropriate cli nical involvement in the decision to enter the study. Other functions of the recruitment process are identified. Analysis of understanding a nd decision making demonstrates that good understanding is neither nec essary nor sufficient for ease of decision making. The recruitment pro cess was time consuming and needs planning and funding in future studi es. Many of these issues are of general importance for trials of treat ment in children.