Advancing Pediatric Cancer Research

The RACE for Children Act will have significant impact on cancer drug development. Among all ongoing cancer trials, more than 70% involve RACE-defined molecular target drugs, but only 6.9% appear to include pediatric-age participants, according to a new analysis conducted by the IQVIA Institute. To discuss this challenge, the roundtable convened participants representing the patient and parent community, the Children’s Oncology Group, the U.S. Food and Drug Administration (FDA), pediatric oncology clinical investigators from the US and Europe, biopharmaceutical companies, and IQVIA executives.

Discussions focused on the implications of the legislation for clinical trials, including approaches that can minimize any disruption to adult trials required for registration, while ensuring that the spirit and intent of RACE is maintained. Promising approaches include collaboration with FDA to prioritize therapies for pediatric development, and broader collaboration and data sharing between all stakeholders at an international level, building on existing models. This will help advance pediatric oncology, avoiding duplicative trials of multiple drugs with the same mode of action in these rare pediatric populations, and enabling parallel advancement of adult therapies.

This discussion brief and the Roundtable discussion on which it is based were produced independently by the IQVIA Institute for Human Data Science as a public service, without industry or government funding.