(157) Identification and Quantification of Barriers to Achieving Clinical Trial Diversity

Background: Clinical trial diversity is critical to ensure the generalisability of safety, efficacy and required dose treatments for the target population. Diversity is a broad concept that encompasses various dimensions which can overlap and intersect rather than act as distinct entities. In order to address barriers to achieving diversity in clinical trials, these entities should be noted in trial design and implementation stages.

Objectives: To identify and assess the intersectional qualities of the barriers to diversity in clinical trials.

Methods: This is a non-interventional study conducted between February and August 2021. We carried out 17 semi-structured interviews with key informants (KI) from different countries using the Multi-Regional Clinical Trials Center Diversity Framework (MRCT) as a prompt for diversity barriers. We first scoped which barriers are most common by providing the absolute frequency of their mentions in the interviews and explored co-occurrence (intersectionality) patterns. Then, we leveraged natural language processing (NLP) methods to provide further details on these findings. We perform content analysis by aggregating pre-processed words by diversity dimension to identify shared trends and themes across KI perceptions. Lastly, we performed k-means clustering to assess the presence of subgroups with shared challenges to clinical trial diversity.

Results: We identified awareness of clinical research, site accessibility and socioeconomic status as the most common barriers to diversity in clinical trials globally, followed by age, race and ethnicity and sex/gender. Intersectionality analysis revealed unique intersection patterns among barriers across all KIs. Content analysis highlighted ‘trust’ and ‘media’ as key terms related to clinical research awareness; geographic location (‘rural’ vs. ‘city’) and ‘distance’ as the main challenges to site accessibility and socioeconomic vulnerability and public and private healthcare spheres as factors influencing the socioeconomic status barrier. Through cluster analysis, we identify three clusters. In cluster 1, awareness of clinical research is the most prevalent barrier, while site accessibility is for KIs in cluster 2. No meaningful patterns were discerned from cluster 3.

Conclusions: Common issues are identified across all KIs’ perceptions, most prominently recurring challenges such as awareness of clinical research, site accessibility and socioeconomic status, in achieving clinical trial diversity. The intersectional nature of these dimensions adds complexity to the analyses. Some of these barriers may be culture-specific, while others were shared across KIs interviewed. This may indicate the need for strategic and precise interventions.