Quality-of-life research in the Pediatric Oncology Group: 1991-1995.

Quality-of-life end points for cancer clinical trials have received much attention in the adult literature. However, within pediatric cancer clinical trials, the inclusion of these alternate end points has only recently been considered. We review the Pediatric Oncology Group's approach to research in this area and describe our guidelines and protocols that incorporate quality-of-life end points and several of the methodologic barriers that must be addressed.