With the recent passing of the Omnibus Spending Package, in 2023 the FDA will now make mandatory the filing of diversity plans to support Phase 3 trials1 . Therefore, as an agency requirement, sponsors will be looking to identify more diverse physician and patient populations to participate in their clinical trials. This additional requirement makes the already competitive site selection landscape more complex, as sites will now be assessed on their ability to engage, recruit, and retain underrepresented populations in clinical trials.
To support the clinical research site community in meeting these new site selection requirements, Total Diversity recently conducted User Acceptance Testing (UAT) of its revised Site Qualification Form (SQF) that assesses site readiness when sponsors are qualifying sites for diversity competency. Key objectives of the study were to assess the following:
- Usability of a revised Site Qualification Form with a proprietary diversity attributes section;
- Trends related to site characteristics;
- Site-declared diversity priorities.
The UAT study sites included Total Diversity partner sites (both academic and private) which were geographically dispersed and had previously completed the Diversity Site Assessment Tool (DSAT). Participants then used and evaluated TOTAL’s Site Qualification Form for ease of use and potential usefulness when responding to Sponsor inquiries on a site’s diversity capabilities.
TOTAL’s UAT showed that 100% of the participants representing 20 sites rated the Site Qualification Form as intuitive and useful for preparation of site qualifications by sponsors. As sites address recruitment, enrollment and retention strategies, and other patient focused services, the Total Diversity revised Site Qualification Form will potentially position sites to be more competitive in the site selection process and more likely to achieve study requirements for inclusion of diverse populations. Therefore, having been validated by our User Acceptance Test, this form will now be used with Total Diversity’s Site SOPs for Diversity Readiness.
Two additional observations worth noting are site-related trends and site-declared diversity priorities. First, only 20% of the sites surveyed indicated they have completed any type of diversity training. The remaining 80% of the sites have not completed any type of diversity training and are awaiting guidance from Sponsor and CRO partners to deliver this support. Second, the categories “recruitment and community outreach” and “site team development” were identified as the top two priorities for addressing the sites’ diversity concerns. While beyond the scope of this publication, these important observations will be further explored in a future Total Diversity article.
Amanda Rangel, MS, Senior Vice President, Business Development, Total Diversity
References:
1CenterWatch Weekly, 2 January 2023: https://cms.centerwatch.com/articles/26402-omnibus-spending-
package-makes-fda-diversity-plans-confirmatory-trials-mandatory
In our continued effort to meet sites “where they are” in regard to their individual diversity competency, the SQF and SOP for Site Diversity Readiness are but a few examples of Total Diversity’s numerous data driven products and site support services to enhance sites’ abilities to increase diversity in clinical trials. Please visit our solutions page to learn more: https://totaldiversity.com/solutions/