Document resource
The WHO defines health equity as ‘the absence of unfair, avoidable or remediable differences among groups of people based on various dimensions of inequality (eg, sex, gender, ethnicity, disability or sexual orientation)’.1 In the context of clinical trials, equity is entangled with diversity (improving representativeness) and inclusion (eliminating barriers to participation) (DEI: diversity, equity and inclusion). These concepts—which are commonly used interchangeably in the literature—inform the design and conduct of trials that enrol participants targeting populations most likely to benefit.2 Interest in DEI in clinical trials has been increasing for the last two decades.3 However, evidence has shown that participants in randomised controlled trials (RCTs) usually do not fully represent the population afflicted with the condition/disease being studied and underserved groups are often excluded.3 The UK National Institute for Health and Care Research considers 34 underserved groups, classified by four factors: demographic (n=6), social and economic (n=14), health status (n=12), and disease specific (n=2).4 High-income countries are becoming more diverse. In the USA, the need to improve RCT equity has been recently highlighted.3 Investigators aiming to respect equity in their RCTs should use a framework like PROGRESS Plus (Place of residence, Race, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and ‘Plus’ that includes other context specific factors).5