Conceptualization, operationalization and utilization of equity, diversity and inclusion in clinical trials, 1990-2023

Clinical trials need to ensure that data collected for interventions reflects the population most likely to benefit from these interventions. A recent study of clinical trial participants between 1997 and 2014 across 29 countries found that nearly 86% were identified as White. Another study found that, despite having a higher risk of developing dementia, the Black population are underrepresented in Alzheimer’s disease trials, as only 2% of participants were Black. Lack of diversity is a mirror for broader social and economic inequities, often limiting individual’s access to health care system. While there is growing recognition of equity, diversity and inclusion (EDI) in clinical trials, its current use appears undermotivated due to a lack of understanding of EDI and barriers to prompting EDI. Conceptualizing EDI is vital for addressing disparities in health and understanding how EDI influences clinical practice. Recent guidelines and recommendations from the US National Academics of Science, Engineering and Medicine (NASEM) call for both individual and system-level efforts to drive inclusion and diversity in clinical trials. The past few years have seen a massive growth in global awareness for EDI; fostering conversations that have revealed asymmetries in power and privilege across the fabric of health and research. These global conversations have increased demand for better conceptualization of EDI, understanding the nuances of EDI constructs, measurements, and interpretation of EDI and related findings within the context of clinical trials. Previous studies on this topic fall short of defining the social constructs underpinning EDI, conceptualization and metrics for assessing them.