The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.

A wide range of factors has detrimental impacts upon equity, diversity, and inclusion in clinical trials, amongst which participant burden can be significant. In addition to the potential physical burdens associated with investigational interventions, participants may face onerous demands related to factors like travel, time commitments, psychological, or logistical challenges. Many of these factors have been shown to create barriers that disproportionately affect certain groups like minoritised ethnic groups, people with caring responsibilities, and older adults. One increasingly problematic aspect of participant burden is associated with an excessive volume of data collection, much of which may lack direct relevance to the study's primary objectives and may never be analysed. Although pragmatic and participant-centred trial methodologies have risen in prominence over the past decade, quantitative evidence demonstrates that trial complexity and data volumes are continuing to rise. The widening gap between the notion of participant-centricity and the realities of current trial practice underscores the need for a shift in approach. Reducing unnecessary burden should be regarded as a moral obligation across all clinical trial designs to avoid the systematic exclusion of certain groups. With a focus on data-related aspects, this paper examines the ethical implications of undue burdens upon participants and proposes measures to help minimise and mitigate these burdens. In addressing this issue, researchers contribute to broader efforts to enhance inclusivity and representation in clinical studies.