Diversity in Clinical Trials: Breaking Barriers Increasing Inclusion - A Site Perspective

Résumé fourni par la source

The lack of diversity within clinical research trials, particularly regarding ethnic minority representation, has been a widely reported issue for more than two decades [1,2]. The global COVID-19 pandemic further illustrated the discrepancy between ethnic minority disease burden and representation within clinical trials and highlighted the need for more inclusivity [3]. Regulating bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) have subsequently released guidance, outlining recommendations for sponsors aimed at bolstering ethnic minority recruitment in clinical research trials. Following on from this, many sponsors and clinical research organisations have released their own white papers outlining barriers to clinical research participation and potential solutions. However, many of these white papers appear to remain as theoretical discussions rather than transforming into actions. This could be why despite the surplus of papers; there remains a challenge at the ground level with clinical research sites experiencing difficulties in recruiting and retaining diverse clinical research participants. This ongoing challenge represents the potential misalignment between the strategies theorised by the sponsor and key stakeholders and the pragmatism at a site level. Furthermore, diverse recruitment has rarely been defined, viewed and scrutinised from the perspective of a clinical research site who operate on the frontlines of clinical trial delivery. This paper outlines an actual approach taken by a clinical research site to combat the challenges of diverse representation within clinical trials at a research site level. We are convinced that increasing diversity in trials is possible through taking positive action and enriching the discussion around diversity. The arguments and practices showcased provide a blueprint for other institutions to adapt and adopt methods which have been proven to make a difference. We also provide feedback to Sponsors and key stakeholders from a site perspective on support required at a ground level.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.