The academic-led, industry-partnered collaboration Equitable Breakthroughs in Medicine Development (EQBMED) has released an assessment tool for clinical trial sites to evaluate their ability to perform diverse trials and chart out a path toward improvement in health equity.
The tool, called the Site Maturity Assessment Model, was published in Trials on Nov. 14.
“Strategic investment in clinical trial diversity requires structured assessment of site maturity as a starting point for transformative, inclusive action,” Tesheia Harris, EQBMED senior adviser and former chief strategy officer at the Yale Center for Clinical Investigation at the Yale School of Medicine, said in a Nov. 20 release. “The EQBMED model is pivotal in guiding sites to identify and prioritize key areas to enhance their capability for diverse clinical trials.”
The model is meant to bring together two aspects of clinical trials—community engagement and research operations—that are often kept separated but are both key for improving diversity, according to the release.
The model is made up of 11 components that cover organizational, community engagement and trial operations factors for the site. Each component has two to seven questions which, when answered by the site, are meant to capture the site’s capabilities in that area. Components include bidirectional community partnerships, technical infrastructure and programs addressing barriers to participation, to name a few.
In the paper, EQBMED researchers tested the model with three sites ranging in size from 250 to 1,000 beds. The initial assessment took four to seven working sessions to complete over a period of eight to 10 weeks, with additional offline data gathering for the assessment taking an estimated six to 10 hours.
At the end of the full assessment, each site had identified its strengths and potential areas of improvement. For example, one site seeking to expand the volume and reach of its trials decided to train more staff and implement a clinical trial management system.
The model went through 20 versions over a period of two years, according to the release, and was crafted by a range of experts including pharmaceutical company representatives, federal organizations, community leaders, scientists, healthcare sites and academic experts.
The assessment is now being used at a range of clinical trial sites, including federally qualified health centers and safety net hospitals, with support from the EQBMED and the Yale School of Public Health, EQBMED said in the release.
The EQBMED is led by the Yale School of Medicine, the Morehouse School of Medicine, the Research Centers in Minority Institutions Coordinating Center at the Morehouse School of Medicine and the Vanderbilt University Medical Center. Amgen and Merck became the initiative’s first industry partners in September.