A regulatory lens on an industry imperative: Diversity in clinical research

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It is increasingly important to focus on the relatively neglected area of inclusivity of diverse populations within clinical trials. It is now an area that affects not just clinical research, but also the availability of new medicines and therapies to all patients. Diversity in clinical research is in a new era. It is imperative, not just in a business sense but also in a moral and social justice sense, to focus on inclusivity. For many years, diversity has not been a priority in clinical research. Historically, there have been multiple priorities and facets within the industry that have coalesced to enable successful clinical research. However, more comprehensive research will have to embrace diverse populations. Now that there is a long-awaited spotlight on this area, there is motivation from all members of the clinical research industry to do better. While this realisation is long overdue, there is still serious attention that needs to be paid to the methodology employed to accelerate diversity initiatives. Regulatory affairs must challenge the clinical research community to renew its focus on diversity and inclusion.

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