It’s this author’s view that it may be a mistake to think of early phase trials as having a therapeutic impetus.  U.S. regulations require that, when we enroll children, we view phase 1 trial participation as therapeutic. However, a recent meta-analysis concluded that phase 1 trials in children cannot generally be presented as having a therapeutic risk/benefit. Thus, phase 1 trials in children cannot be reconciled with research regulations. (translationalethics.com)