The BIA comments on the HRA-MHRA Inclusion and Diversity Guidance
In its feedback on the draft HRA-MHRA Inclusion and Diversity Guidance for clinical trials, the BIA supported the principle of including diverse populations but raised key challenges, including capturing sensitive socio-economic data, aligning UK requirements with global standards, and overcoming recruitment barriers for underserved groups. BIA called for clear terminology, unified international approaches, and tailored guidance for rare diseases and paediatric trials. To support implementation, the BIA recommended using case studies, providing training for reviewers, and fostering exchanges on best practices to ensure inclusive protocols without delaying early-stage clinical development.
