How do we make trials equitable and inclusive?

Problem

People from ethnic minority groups suffer more strokes at younger ages, of greater severity, with worse outcomes and with increased risk of reoccurrence, compared to white people. A similar picture exists for other cardiovascular conditions. When trials exclude population groups which potentially have the most to benefit from research (because they have the worst baseline health) this contributes to waste in research, and needs to be addressed.

Approach

We retrospectively examined, step-by-step, the procedures we had followed during our planned trial (BP:Together) to reveal how normalised and routinized trial assumptions, procedures and practices can systematically exclude people from ethnic minorities and other disadvantaged groups. Using this learning, we are developing new methods to make research more representative and inclusive, in order to deliver better science.

Findings

National statistics for disease prevalence and severity help to map out geographical regions worst affected by particular conditions, which need to be prioritised as study sites. Likewise, if conditions disproportionately affect particular racialised groups, they need to be over-sampled for the trial. This can be at the site selection stage, where sites with more ethnically-diverse patient lists are given extra support to encourage participation. Extra time and resources need to be costed in at the application stage to ensure enough contact time for high recruitment and retention. Trial teams should consider hiring researchers with appropriate cultural and language skills, and to develop partnerships with community groups for sustainable current and future research relationships.

Consequences

Researchers and trialist needs to acknowledge and respond to existing structural inequalities in society so as to not replicate them. This requires re-visiting current, normalised practices and procedures and modifying them appropriately in order to make research, and the benefits derived from them, more accessible to everyone.