- Race and ethnicity data are often absent or inconsistently reported in clinical datasets and medical manuscripts, leading to unreliable interpretation of results.
- Publishing guidance and legislation are needed to improve consistency.
The question of how to clearly define race and ethnicity in biomedical literature has been widely debated and with the advancements in genomic research, the inconsistency of using race and ethnicity as measures of diversity has been called into question. A recent review article by Rossella Ferrari has explored studies on race and ethnicity and examines the ethics around reporting them in biomedical literature.
A lack of consistent collection of race and ethnicity across countries and clinical studies can lead to unreliable interpretation of results. Underreporting of data can also reduce opportunities to identify differences in outcomes between subpopulations. Moreover, the criteria for race and ethnicity assessments are often US- or EU-centric, which can be misleading when trying to understand determinants of disease. Clinical decisions can be impacted by false beliefs on race and ethnicity and under-representation of minority populations in clinical trials. For example, pain perception is influenced by cultural differences, which, if not accounted for, can lead to misleading recommendations and increased pain burden.
Race and ethnicity data are often absent, inconsistent, incomplete or contradictory, which leads to unreliable interpretation of results.
Part of the problem is that designations of race and ethnicity in biomedical literature are highly heterogeneous. Recently, medical publishers have put guidance into place for reporting these data. The New England Journal of Medicine announced that from January this year, authors will be asked to provide information on the representativeness of the patient populations enrolled in their studies. The Journal of the American Medical Association has also recently published practice guidelines to improve race and ethnicity data reporting in clinical studies and regulatory documents.
EU legislation bans discrimination based on race and ethnicity, but non-discrimination laws on access to healthcare are the responsibility of individual countries and vary greatly. A recent comparison of approved drugs in the US and Europe also highlighted inconsistencies in designations of race and ethnicity in regulatory documents.
Ferrari concludes her perspective by calling for an essential amendment to EU legislation to cover enrolment of minorities in clinical trials and hopes such legislation could lead to consistent use of race and ethnicity concepts in both regulatory documents and medical publications.