Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, Nigeria.
PENTA, Corso Stati Uniti 4, 35127, Padua, Italy.
Ther Innov Regul Sci. 2022 Nov;56(6):991-1003. doi: 10.1007/s43441-022-00410-3. Epub 2022 May 20.
The concept of health equity-the attainment of the highest possible level of health for all members of society-requires equitable access to all aspects of healthcare, including pediatric drug development. 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 "one size fits all" 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. These studies may serve as templates for facilitating equity in pediatric drug development from aspiration into operation.
健康公平的概念——即实现社会全体成员的最高可能健康水平——需要公平获得医疗保健的各个方面，包括儿科药物开发。然而，许多社区在儿科药物开发项目中的代表性不足。参与的障碍包括地理、经济、种族/民族偏见、法律、文化、语言和其他因素。虽然没有“一刀切”的方法来解决这些障碍，但疾病控制中心、世界卫生组织和其他全球卫生组织都认识到，利益相关者和社区参与临床研究是建立更公平的医疗保健系统的基石。在本文中，我们将介绍利益相关者和社区参与罕见病和其他医疗保健领域临床研究的案例，作为积极吸引代表性不足的社区并促进其参与儿科药物开发项目的策略和实践的范例。这些研究可以作为促进儿科药物开发从愿望变为现实的公平性的模板。
