Clinical trials in children

Clinical trials in children have improved outcomes in areas such as neonatology2,3 and HIV.45 Trials in paediatric oncology are certainly notable for achieving high degrees of participation, yet trials in children infected with HIV have also been successful despite great obstacles. HIV carries, for example, considerable stigma, and cultural and language barriers are common because of the ethnic origin of many children with HIV and their families. Children are often unaware of their diagnosis, thus issues of parental consent and the child's assent are complex. Furthermore, as HIV is fairly rare in Western Europe, trials should be multicentre and international, increasing the complexity of approval processes and drug distribution. Nevertheless, collaboration by the Paediatric European Network for the Treatment of AIDS (PENTA), for instance, has resulted in six completed clinical trials since the network was founded in 1991, with three more trials ongoing and two just launched (http://www.pentatrials.org). An important factor for the sustainability of PENTA has been ownership by participating paediatricians and other activities undertaken by the network, including training, exchange of personnel, writing guidelines, and developing links with cohort studies.