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However, many communities are under-represented in pediatric drug development programs. Barriers to participation include geographic, economic, racial\/ethnic bias, legal, cultural, linguistic, and other factors. While there is no \u201cone size fits all\u201d approach to addressing these barriers, community engagement and collaboration is recognized by the Centers for Disease Control, the World Health Organization, and other global health organizations as a cornerstone for building a more equitable healthcare system. In this article, we will present case studies of stakeholder and community engagement in clinical research for rare diseases and other areas of healthcare, as examples of strategies and practices for actively involving under-represented communities and fostering their participation in pediatric drug development programs. 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