Improving patient diversity in clinical trials has been a major initiative by the FDA as evidenced by the 2020 Enhancing the Diversity of Clinical Trial Populations guidance as well as the 2022 Diversity Plans guidance. Many forward-thinking site operators are looking for new ways to access potential study participants that better reflect the population most likely to use the drug in clinical practice, if the drug is approved. Ultimately, achieving diversity requires bringing trials to new communities and earning the trust of the patients. A key enabler for this is technology.
In this post, we’ll explore three ways to use tools and technology to enhance patient diversity for a clinical trial.
1. Assessing Diversity – The DSAT
The Diversity Site Assessment Tool (DSAT), developed by the Society for Clinical Research Sites (SCRS) Diversity Work Group, enables sites to conduct a self-assessment of their ability to recruit and cater to the needs of a diverse patient population. This extensive questionnaire aims to evaluate the internal and external factors that impact a site’s ability to support a wide variety of clinical trials. The DSAT assesses responses to determine a numerical score representing the site’s current level of inclusivity. This scores range from 0 to 150, with 150 representing the gold standard for best practices.
Sites with lower DSAT scores can pinpoint areas for growth. Furthermore, they can access resources available in the SCRS Diversity Program repository to make targeted improvements. On the other hand, sites with higher DSAT scores can leverage this metric as a marketing tool to share with sponsors.
2. Enhanced Patient Engagement
Building trust within diverse communities is a critical aspect of recruiting and retaining underrepresented patient populations. Community engagement helps raise awareness about the importance of clinical research and the opportunities available to participate. From establishing partnerships with community leaders to creating outreach programs, engagement is most impactful with a ground-roots approach.
Once you enroll diverse patients in your clinical trial, it’s crucial to retain them throughout the study. A comprehensive Clinical Trial Management System (CTMS) enables better communication between site teams and patients. Features such as appointment reminders and secure messaging systems help to keep patients engaged, informed, and connected throughout the trial.
3. Supporting New Investigators and Clinical Research Sites
To support enrollment and diversity targets, sponsors may need to rapidly start-up new sites in locations with higher concentrations of minority patients. Or existing sites may need the ability to partner with new-to-research physicians for access to target populations.
Sites and investigators that are relatively new to clinical research increase their likelihood for operational success when they are standardized on an electronic solution, like eSource. Electronic source, or eSource, streamlines workflows, and builds in quality at the point of capture. This subsequently reduces sites’ traditional reliance on deeply experienced coordinators with years of experience. For instance, eSource forces completion of all required data points, has alerts to flag potential data entry issues, and always populates date and time entries in standard research format – all the “little things” that may take years of experience to internalize.
By enabling faster and more efficient site workflows, eSource frees up sites from clerical tasks, allowing them to invest more time on recruiting and retaining patients.
“Standardization of the initial source reduces the workload for both sites and CRAs,” explains Takoda Roland, Associate Director of Clinical Operations at Sitero, an innovative CRO. “This ensures that critical data points are not missed. With site-based eSource, standardization is easier to manage with protocol amendments and clearer version control.”
Getting Started with New Technology
Altogether, by harnessing the power of technology, sites can contribute to a more inclusive future in clinical research. This ensures the overall effectiveness of new treatments for all patient populations. CRIO helps sites achieve their diversity goals by leveraging technology to facilitate broader and more inclusive patient experiences. Data indicates that sites that use CRIO have twice the patient diversity than industry average, and have higher enrollment rates than non-CRIO sites by almost 40%.
CRIO designs eClinical solutions that facilitate diverse patient enrollment and real-time data capture, all backed by 365/24/7 customer support. CRIO sites also boast 40% fewer reduced protocol deviations and 70% reduced FDA audit risk. We’d love to give you a walkthrough. Schedule a demo to explore CRIO, the industry’s #1 site-base eSource solution.
Related Reading: CRIO Sites Out-enroll Non-CRIO Sites by 39%
Related Reading: CRIO Sites Have Twice the Patient Diversity