Maximizing efficiency while complying with FDA & EMA regulations in pediatric cancer drug development: Tufts

To better understand current and emerging trends in pediatric oncology drug development, the USA-based Tufts Center for the Study of Drug Development (CSDD) recently convened a roundtable discussion of senior leaders from drug companies, government agencies, and academia.

Despite medical advances, worldwide a child is diagnosed with cancer every three minutes, and it is the leading cause of death for children in the USA after accidents. Yet on the whole pediatric cancer is a rare disease, and participants are hard to come by.

The roundtable examined various approaches employed by companies to deal with challenges in pediatric oncology drug development, including more efficient use of the data hierarchy of informative events in clinical trials, innovative use of Phase II clinical trial platform for rapid assessment of new drugs in children, adoption of new developments in formulation technology, and participation in multi-stakeholder network collaborations to optimize development speed.