International – FDA, EMA team up on pediatric oncology drug development template

In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.
 
A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans (PIPs) and initial Pediatric Study Plans (iPSPs), respectively.
 
FDA’s Oncology Center of Excellence already maintains a pediatric oncology program that collaborates with EMA in pediatric cluster calls, coordinated through FDA’s Office of Pediatric Therapeutics. “Given the global nature of cancer drug development and the relative rarity of childhood cancer, which impacts study populations for clinical trials, the demand for international collaboration in study design and conduct has intensified,” according to the pediatric oncology program’s informational page on the FDA website.
 
Additionally, citing a 2020 publication in the Journal of Clinical Oncology, FDA now recommends that sponsors of new cancer products submit their new PIPs and iPSPs simultaneously to FDA and EMA “to promote global coordination and international research collaboration.”…