A Comparative Analysis of US and UK Site Self-Assessment of Practices in Recruiting and Meeting the Needs of Diverse Patient Populations in Clinical Trials

Background The comparative analysis of site practices in recruiting and outreach of diverse patient populations in clinical trials is needed for a harmonious approach to navigating solutions for improving patient diversity globally. With the availability of the Diverse Site Assessment Tool (DSAT), such analyses have become feasible. Methods This study presents a comparison of self-reported data related to diversity best practices using the DSAT by members of clinical trials research sites from three distinct cohorts in the United States (US) and United Kingdom (UK). The Diverse Site Assessment Tool (DSAT) is a 25-item self-report measure, exploring best practices for the recruitment of diverse patient populations during clinical trials. The DSAT was administered online via the Qualtrics XM platform. DSAT data for each of these cohorts were retrieved and scored and individual item means were used to conduct reliability, descriptive and inferential statistical analysis. Findings Results indicate that the DSAT is an exceptionally reliable instrument for self-assessment of diversity best practices. Results also showed that among the three DSAT sections, the section of patient focused services shows the lowest scores regardless of the cohort and that DSAT section scores were considerably different between the 2 US cohorts as well as between the US and UK cohorts. Overall, DSAT scores were higher for US cohorts than for the UK cohort. Interpretation Different stakeholders from the US and UK might want to examine the findings of this study carefully and discuss its implications for their own country, sites within it and discuss how harmonized efforts for diversity in clinical trials can be established. Funding Funded by the The Society of Clinical Research Sites, USA. ### Competing Interest Statement Dr Diane Foster developed the DSAT tool. PP has received research grant from Novo Nordisk, and other, educational from Queen Mary University of London, other from John Wiley & Sons, other from Otsuka, outside the submitted work. All other authors report no relevant conflicts of interest for this article. ### Funding Statement The Society of Clinical Research Sites, USA ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: HRA and Health and Care Research Wales (HCRW) Approval. Application does not require HRA/HCRW and REC Approval in order to proceed at participating NHS organisations in England or Wales. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors