October 5, 2016
JUST RELEASED: Pediatric Oncology Drug Development: Maximizing Efficiency While Complying with FDA & EMA Regulations
To better understand current and emerging trends in pediatric oncology drug development, Tufts CSDD recently convened a roundtable discussion of senior leaders from drug companies, government agencies, and academia. Key points from that meeting are highlighted in this report.
Despite medical advances, worldwide a child is diagnosed with cancer every 3 minutes, and it is the leading cause of death for children in the US 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 2 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.
To purchase a single report or subscription, please visit the reports page.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Tufts Center for the Study of Drug Development
Sandra Peters – 617-636-2185