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In Who shall go first? A multicriteria approach to patient selection for first clinical trials of cardiac xenotransplantation, Kögel et al recommend the inclusion of patients who (1) have a (high) medical need for an allograft, (2) have the capacity to benefit from a xenograft, (3) have a ‘real’ choice between enrolment in a first-in-human clinical trial and an alternative life-sustaining treatment option and (4) have no clear record of previous non-compliance.1
As the authors discuss, patient selection must promote the goal of gaining reliable and valid knowledge about the risks and benefits of cardiac xenotransplantation. While the four criteria outlined above certainly promote this goal, we argue it is crucial to add a fifth criterion emphasising the need to include diverse populations, particularly regarding sex, age, ethnicity and socioeconomic background.i In this commentary, we present two arguments for our claim and discuss the impact of neglecting diversity from the first trials on.
The scientific rationale for including diverse populations
First, including diverse populations in the first clinical trials of cardiac xenotransplantation enhances the scientific value of the data by assessing safety and efficacy among various populations. Treatment response can differ among patient (sub)groups as a result of genetic, physiological and socioeconomic factors.2 By including diverse populations from the first trials on, researchers …
Footnotes
X @martinecdevries, @NdeGraeff
Collaborators Not applicable.
Contributors All authors developed the concept and focus of this commentary. LvK drafted and revised the manuscript, with revisions provided by MCdV and NdG. All authors reviewed and approved the final manuscript. LvK is the guarantor of this manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
↵By focusing on ethnicity rather than race, we acknowledge the social, cultural and environmental factors that can affect health and treatment responses, without reinforcing race as a biological category.