Enrolment of children in clinical trials : Botswana perspective.

Abstract

Paediatric clinical trials are crucial to ensure safety and efficacy of medicines in children. This study explored parents’ perceptions in Gaborone, Botswana, regarding children’s participation in clinical trials. One hundred participants completed a self-administered questionnaire. The results showed that 93% of the participants had a good knowledge of clinical trials; 74% thought that children would benefit from clinical trial participation; 63% would not enrol their children in clinical trials; 55% suggested that children should only be enrolled once they have reached the age of 18 years; and 71% reported that only children with an active disease should be enrolled. A large proportion (82%) reported that children’s participation should be voluntary, while joint parental consent was supported by 93% of responders. Regarding children’s assent 91% deemed respect for children’s assent essential, although 52% thought that children’s assent should not override the parental decision. There was a statistically significant correlation between finding clinical trials in general important and children’s participation in clinical trials (p=0.008, Fisher’s Exact Test), as well as the need for individual consent p<0.0001, Chi-Square). There was also a statistically significantly association between respondents, who would allow their children’s participation in clinical trials and who would encourage their family members and friends’ participation in clinical trials (p=0.0001, Chi-Square). An overwhelming 94% advocated for special regulations in Botswana to govern paediatric clinical trials. Almost all participants (99%) explicitly expressed the opinion that there should be global regulations for paediatric clinical trials.