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NEW YORK – May 23, 2023 – With new Food and Drug Administration (FDA) guidance, study sponsors are no longer viewing clinical trial diversity as “nice to have” but as a “must have.” Citeline’s new Sitetrove Diversity Module marries robust site and investigator intelligence with patient age, race and gender data, enabling data-driven decision making to support the diversification of clinical trials.
The Diversity Module includes patient racial demographics from medical claims along with investigator gender data from the Centers for Medicare & Medicaid Services (CMS). The patient data are broken down by Asian, Black/African American, Hispanic, White and unknown. Sponsors will now be able to identify expert clinical investigators with relevant trial experience and who have access to diverse patient populations in one continuous workflow.
Enacted in December 2022, the U.S. 2023 omnibus spending bill requires diversity action plans for Phase 3 or pivotal clinical trials used by the FDA to determine the safety and efficacy of drugs. It reflects a concerted effort to reverse a growing trend: lack of diversity in clinical trials. In fact, according to a recent study, U.S. clinical trial diversity has dropped to its lowest level of the decade.
Citeline’s Sitetrove Diversity Module is designed to support Sponsors’ activities surrounding these imminent requirements, including feasibility, planning and investigator/site selection — all of which drive recruitment strategy. Beyond regulatory requirements, sponsors can leverage this demographic data to demonstrate a broader commitment to clinical trial diversity, equity, and inclusion.
“Clinical trial sponsors now have specific U.S. legal obligations, in addition to ethical ones, for improving diversity in their research studies,” said Dave Laky, General Manager of Clinical & Regulatory at Citeline. “While sponsors may worry about the challenges of recruiting underserved communities, pinpointing where diverse patients are being treated is a great first step towards enrolling these individuals. Our new Diversity Module is one example of how Citeline is actively investing in the expansion of our patient and provider demographic data to enable data-driven decision making.”
Citeline is also developing a Diversity API, scheduled for release later this quarter, that will allow users to analyze ICD10-specific patient counts by age, race and gender, for U.S. clinical investigators and organizations. Additional developments are planned for the Diversity Module in the coming months, including enhanced visualizations, enriched datasets, organization-level diversity insights, and patient landscapes outside the U.S.
Learn more about Citeline’s Sitetrove.
Citeline, a Norstella company, powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial, and regulatory-related decisions and create real-world opportunities for growth.
Citeline’s global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts and more. For more information on one of the world’s most trusted health science partners, visit Citeline.
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