Pediatric Inclusion Alliance

Committed to creating a day when every child with a disease or condition lives to their fullest potential because they are included in clinical research at the earliest possible time.

The mission of the Pediatric Inclusion Alliance is to advance multistakeholder and consensus-based policy workstreams that will together achieve the earliest possible pediatric inclusion in clinical trials for drugs, biologics, and devices across all diseases and conditions without compromising safety.

About the Alliance

For far too long, children have had to wait years for access to safe, effective therapies, often already approved for adult populations. These therapies might well have been even more effective for younger patients if administered at the best time for them. Regulatory agencies are increasingly supportive of earlier inclusion of pediatric subjects in clinical development, and it is becoming more evident that all stakeholders are ready to clarity policies and address challenges as needed to advance this shared goal.

The Pediatric Inclusion Alliance is devoted 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. By combining a deep understanding of the unmet needs of pediatric patients and their families, technical expertise, and real-world experience in medical research and therapy development, knowledge of regulatory guidance and processes, public policy, regulatory knowledge, and public policy understanding, the Pediatric Inclusion Alliance is a united collaborative of stakeholder groups committed to ensuring that children have the earliest opportunity to access safe and effective therapies when those therapies are most likely to have the maximum benefit to them.