N04 - Advancing Earlier Pediatric Inclusion in Clinical Trials: Aligning IRBs, FDA, Industry, and Patient Advocates

Feel free to bring your lunch to this session!


This session will introduce the Pediatric Inclusion Alliance and provide considerations for IRBs as they review pediatric clinical trial protocols. The Pediatric Inclusion Alliance is a multistakeholder alliance dedicated to full, active collaboration among all stakeholders committed to achieving earlier inclusion of children in clinical trials across all diseases and conditions without compromising safety. The Alliance recognizes that IRBs are charged with navigating an ethically complex environment when reviewing clinical trials involving children. The traditional model of sequential therapeutic testing, beginning with adults and only later involving children, has contributed to persistent gaps in approved pediatric treatments and therapies. This session will explore the imperatives driving earlier pediatric inclusion in clinical trials, the practical challenges IRBs face in evaluating pediatric protocols, and examples of real-world success in meeting this need.