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How We Can Use the FDA’s 2022 Diversity Guidance to Make Our Clinical Trials More Inclusive

 
• By Catherine Gregor

Catherine Gregor is the chief clinical trial officer at Florence Healthcare, a leading provider of clinical trial software that helps researchers collaborate and manage workflows and information. Based on her extensive experience in clinical research administration, Gregor explains how the recent US FDA guidance on diversity and inclusion in clinical trials represents a critical opportunity to make clinical research more inclusive and equitable.

Decentralized trials
• Source: Alamy

I began my career in clinical research almost 20 years ago and, in that time, I have seen the industry continually wrestle with the question of how to achieve truly diverse, inclusive trials.

And despite the number of hours and brainpower thrown at solving the problem, trial participation rates among underrepresented groups remain low,

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