Diversity Plans in Action: How to Boost Inclusivity in Trials Faster and for the Long Term

The Food and Drug Omnibus Reform Act (FDORA) and Food and Drug Administration’s (FDA’s) latest Draft Guidance on Diversity Action Planning underscore a significant shift in the consequences of limited diversity in clinical trials. For leading research sponsors, the operative word has become “action” as the clock is ticking to implement best practices and track measurable progress towards truly representative research. However, the reality of recruiting historically underrepresented community members for clinical trials is that barriers to participation are multifaceted and best practices can be labor-intensive. At times, it may seem impossible for research sponsors to establish sustained engagement with communities at the grassroots level required to achieve affective trust.