Achieving Diversity In Clinical Trials Amidst Regulatory Focus

Touted as a long-standing issue, pharmaceutical companies realize that equitable representation of diverse populations in clinical research needs improvement if developing drugs are to have accurate and effective healthcare outcomes. This has led to uneven access to therapies as well as gaps in the industry's understanding of how different disease areas' treatments affect varied people generally. Therefore, a lack of representation might potentially obstruct future clinical advancement and healthcare decision-making.

To combat this, the FDA updated its advice to the industry in 2022 to encourage the enrollment of additional patients from underrepresented racial and ethnic groups. With this guidance, FDA Commissioner Robert M. Califf stated², “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

Amidst these regulatory changes and additional guidance, discover several strategies and best practices used to enhance diversity and advance healthcare for all ethnic groups.