New consensus statement published: Improving the measurement of ethnicity in clinical trials

Background

Ethnicity is an important factor influencing health outcomes and health inequalities. Yet ethnicity-related information is often inconsistently collected or omitted altogether in clinical trials, making it difficult to assess whether research findings apply to diverse populations.

Until now, there has been no international consensus on which ethnicity-related variables researchers should prioritise when designing and reporting clinical trials.

New guidance for researchers

To address this gap, an international team conducted a Delphi study and consensus process involving researchers, trialists, journal editors, funders, patient advocates, and other experts from 22 countries.

The participants reviewed 35 potential ethnicity-related variables and developed a set of recommendations for trial researchers. The final guidance identifies 18 key variables, grouped according to whether they are critical for all trials, important in some contexts, or relevant only for selected studies.

The panel concluded that researchers should prioritise collecting information on country of birth, self-identified ethnicity, and language. The recommendations aim to improve the reporting of ethnic diversity in clinical trials, helping generate more representative evidence and supporting efforts to reduce health inequities.

While developed for randomised clinical trials, the guidance may also be useful for other types of health research.

Miro Anter