Underrepresented patient populations in cardiovascular device trials: A transatlantic expert narrative on sex, age, demographic groups, and geographical background

Abstract

External validity of clinical research can be optimized by an adequate representation of all patient groups within a disease spectrum. This emphasizes the need of enrolling patient groups who have been historically underrepresented on the basis of sex, age, demographic groups, or geographical background. Especially in countries with pronounced disparities, raising awareness regarding the existing gaps in future clinical studies continues to be a priority. Census-defined demographic minority groups have been reported to have less access to high-quality healthcare, are less studied in clinical trials, and have less group-specific high-quality data on outcomes after treatment. Additionally, efforts should continue towards enrolling a balanced or at least representative distribution of women and men in clinical trials; and, enrolling age ranges that are consistent with patients suffering from the index disease. Aiming for heterogeneity in study populations will undoubtedly contribute to advancements in medicine, the development of improved therapies, and better outcomes. Analyses on demographic groups have revealed significant disparities within some regions of the world, underlining the need to further investigate whether access to advanced therapies is consistently offered to all members of a nation. To foster international collaboration in cutting-edge clinical research with adequate patient representation, this document presents insights and consensus on fundamental issues, including available classifications of demographic groups in Europe and North America, and presents a standardized approach for collecting geographical background data.