Global Regulatory Landscape of Diversity Plans for Clinical Trials

Enhancing meaningful participation of underrepresented communities in clinical trials is critical for health equity. Regulatory agencies around the world have introduced initiatives to enhance the diversity of clinical trials. In this newsletter series, we will provide a comprehensive overview of the current global guidance documents on diversity.

Kick-off February with us with our comprehensive overview of the global guidance documents that underpin plans for representative clinical trials. In the second week, we will delve into the FDA’s guidelines on diversity plans. In the third week, we will focus on the EMA’s guidance documents. We will conclude our series in the fourth week with a deep dive into Health Canada’s guidelines.

• Week of Feb 12, 2024: Overview of Global Guidance Documents

• Week of Feb 19, 2024: FDA Diversity Guidance Overview

• Week of Feb 26, 2024: EMA Diversity Guidance Overview

• Week of March 4, 2024: Health Canada Diversity Guidance Overview

By the end, you will have a deeper understanding of regulatory guidance on clinical trials, how agencies differ, and what steps you can take to improve diversity planning in clinical trials. These policies are important stepping stones towards equitable research in life sciences and medicine—research that ultimately shape our healthcare and our lives. We at CCS welcome your queries and thoughts.

Please get in touch with us today for a more in-depth conversation.

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