Children are not being provided with the same opportunities as adults to participate in the medicines research and development (R&D) process. Reticence to accepting children as active participants in research beyond that of clinical trial participants might be due to how researchers view children. AIM: To examine how professionals associated with medicines R&D construct children and involvement and understand how this affects the uptake of children's involvement. METHODS: This multimethod study comprises a systematic analysis of political speeches focusing on children's medicines regulation, a scoping review of pharmaceutical medicines research presenting children's views and a discourse analysis of key informant interviews. Bakhtinian discourse analysis is used to examine the explicit and implicit attitudes and ideas surrounding children's involvement in the context of role theory. Suggested barriers, facilitators and potential opportunities to improve its uptake are presented. FINDINGS: Children have clear views on medicines that have been reported in peer-reviewed journals, which some researchers find informative and valuable. Children are mainly constructed as passive actors, rarely considered beyond the role of clinical trial participants, and involvement as problematic and resource intensive. However, participants suggest that children's insight could prove valuable for generating new ideas, improving research designs, and understanding the medicine taking experience. Findings from the interviews suggest that children can be constructed differently by the same speaker, depending on the speaker's assumed role from a cast of identified salient roles - the dramatis intrapersonæ. This has implications for how children's involvement is perceived and adopted. A conceptual framework of factors affecting children's involvement is presented. CONCLUSIONS: Children's involvement in early-stage medicines R&D can only be successful if there are fundamental changes in the mind-set of researchers regarding children's ability to actively contribute. This requires improved resources and education for researchers, and encouragement for those who develop medicines to talk directly with sick children.