All Times EDT
Keywords: Master Protocol, Pediatric, Cancer, Biomarker-directed, Clinical Trial
It is well recognized that cancer drug development for children and adolescents has many challenges, from biological and societal to economic. Pediatric cancer consists of a diverse group of rare diseases, and the relatively small population of children with multiple, disparate tumor types across various age groups presents a significant challenge for drug development programs as compared to oncology drug development programs for adults. Uniform international master protocol for biomarker-directed studies, platform trial and common control would be encouraged to facilitate the pediatric development including possible registration strategies as much as possible. In this presentation, we will present master protocol design considerations and focus on one successful case example of master protocol in pediatric cancer trials.