Our Mission

Our aim is to advance the development of novel therapeutics for children globally. Based at Harvard Medical School and Boston Children's Hospital, the Pediatric Therapeutics and Regulatory Science Initiative provides a forum for collaboration with academia, patients, policymakers, and industry.

Participants in clinical trials deserve to be assured that their contribution will benefit our scientific knowledge and future patients.
— Dr. Florence Bourgeois, Initiative Director

Recent research

The Initiative's research has been published in JAMA, JAMA Pediatrics, Lancet Child & Adolescent Health, PLOS Medicine, and Pediatrics, among others. For more information on our current and past work, see Our Research.

One current project includes →

Impact of Europe's pediatric regulation

In collaboration with the European Medicines Agency, we are studying the completion and impact of pediatric studies conducted under the EU's Pediatric Regulation, which entered into force in 2007. The first study from this project, published in PLOS Medicine, analyzed the completion and results of 326 pediatric clinical trials. Our second study, published in Lancet Child and Adolescent Health, examined the availability of pediatric information for new medicines approved by the EMA from 2010-2014.

Where our work has appeared