„Kaukasisch“ in medizinischen Studien: Ethische, rechtliche und wissenschaftliche Perspektiven am Beispiel der ophthalmologischen Studie „Low-dose AtropIne for Myopia Control in Children“ (AIM)

Abstract

Background

The term “Caucasian” is still used to describe study populations in medical publications, often without explicit definition or transparent operationalization. This can limit reproducibility, comparability, and external validity. As a case example, we use the first German clinical atropine trial for myopia control in children, the Low-dose AtropIne for Myopia Control in Children (AIM) study.

Methods

Commentary based on an analysis of publicly available documents related to the AIM trial (protocol/published information) and a structured literature and policy/statement review (PubMed and relevant guidance documents) on race/ethnicity reporting, the use of “Caucasian”, and fair participant selection.

Results

Using the first German clinical atropine trial for myopia control in children (AIM) as a case example, we show that the target population is described as “Caucasian”, while the definition and assignment procedures are not transparent in public materials. This affects interpretability and transferability, especially when cohorts are used for follow-up analyses (e.g., genetics).

Discussion

We discuss scientific (definition/validity), ethical (fair selection), legal (equal treatment and discrimination risks), and regulatory (target population/transferability) implications. We emphasize the need to distinguish social categories from geographic recruitment and from biological hypotheses, which require appropriate variables and explicit justification.

Conclusion

Population descriptors such as “Caucasian” should only be used when they are defined, justified, and transparently operationalized. More precise reporting standards and alternatives are available.