Addressing Social Determinants of Health in Clinical Trials to Enhance Diversity

Wednesday, 18 September 2024, 02:39

Social determinants of health play a crucial role in clinical research. The new FDA initiative aims to enhance diversity in pivotal trials by requiring detailed enrollment plans based on race, ethnicity, age, and sex. This initiative represents a significant step forward in clinical studies and research, ensuring that clinical trials better reflect the populations they serve.
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Addressing Social Determinants of Health in Clinical Trials to Enhance Diversity

The FDA has announced a pivotal initiative to address social determinants of health (SDOH) in clinical trials. Expected to launch in 2025, this initiative will mandate plans for enrollment by race, ethnicity, age, and sex for all pivotal and phase 3 trials. Emphasizing the importance of diversity in clinical research, the initiative seeks to ensure that clinical studies more accurately represent diverse populations. This will not only enhance the relevance of clinical findings but also inform better healthcare technology and medical practices.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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