Summary
This guide outlines a strategic framework for implementing diversity, equity, and inclusion (DE&I) in clinical trials. It emphasizes that DE&I should not be treated as a mere project or series of tactics but as a systemic transformation requiring top-down management. The document details the importance of collaboration and stakeholder engagement, highlighting the necessity of involving under-represented communities in the process. It suggests identifying key stakeholders who are committed to systemic change and emphasizes the importance of building lasting relationships with them. The guide also presents a framework for identifying and addressing barriers to diversity in clinical trials, advocating for the use of advisory boards to gather insights from patients and community members. Furthermore, it discusses the creation of a barrier breakdown structure to categorize and manage these obstacles effectively. The document concludes by stressing the need for a comprehensive and evolving approach to DE&I, ensuring that strategies are integrated into all aspects of clinical development.
