Children and medical research

A considerable proportion of medical treatments for children are based on estimates and assumptions rather than clinical evidence. Clinical research on children provokes intensive discussion internationally. While children are protected from the risks of clinical trials, they are hindered from receiving the benefits of pharmaceutical innovations obtained by adults. The recruitment of children into research trials is more complicated than that of adults for several reasons: 1) the physical size and relative water content of the body differs not just compared to adults but also amongst subgroups of children making the group of potential participants relatively small; 2) diseases common among adults may be rare among children and vice versa; 3) children's ability to understand the significance of a study varies and depends on the age and developmental stage of the child; and 4) depending on the level of understanding, differing views have been given on the degree of respect that should be paid to a child's right to consent, assent, or refuse to participate in a trial. We suggest that: 1) the number of children recruited in research trials should be kept as small as possible, but large enough to enable scientifically valid results; 2) special training should be made mandatory for researchers who study diseases of children; 3) children or adolescents should participate in decision-making that concerns them whenever possible; and 4) in minor procedures, the consent of just one parent is sufficient.