Citeline presents a tool to support the diversification of clinical trials
It allows medical decisions to be made based on patient demographics.
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Combining robust clinical investigator and site intelligence with patient demographics to support clinical trial diversification, Citeline's Sitetrove diversity module was recently introduced.
Highlighting new guidance from the Food and Drug Administration (FDA), in which study sponsors no longer consider clinical trial diversity to be a "nice to have" but a "must have," Citeline's new 'Sitetrove Diversity Module' unites robust investigator and site intelligence with patient age, race, and gender data, optimizing decision-making.
Dave Laky, general manager of Clinical and Regulatory at Citeline, stated in a press release:
Clinical trial sponsors now have specific U.S. legal obligations, in addition to ethical ones, for improving diversity in their research studies.
What is it about?
Citeline explains that the diversity module includes racial demographic data from medical claims patients along with gender information from the Centers for Medicare and Medicaid Services (CMS) investigator.
It notes that because patient data can now be disaggregated by race (Asian, Black/African-American, Hispanic, White, and unknown), sponsors will now be able to identify expert clinical investigators with experience in relevant trials and who have access to diverse patient populations in a continuous workflow.
“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,” Citeline highlights.
It is also important to stress that beyond regulatory requirements, sponsors can leverage this demographic data to demonstrate a broader commitment to clinical trial diversity, equity, and inclusion.
“We are truly making an impact on patients’ lives. … Who doesn’t want to be a part of this work?” – Norstella CEO Mike Gallup #Pipeline2Patient@Citeline, @evaluatepharma, @MMITNetwork, @panalgoinsights, @TheDedhamGroup pic.twitter.com/OdvCwzITiK— Norstella (@NorstellaCo) May 23, 2023
Citeline welcomed the U.S. 2023 omnibus spending bill enacted in December 2022, which requires diversity action plans for Phase 3 or pivotal clinical trials used by the FDA to determine the safety and efficacy of drugs.
The measure, which took into account a recent study pointing to the dramatic reduction in diversity in clinical trials in the U.S., seeks precisely to reverse this trend.
“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,” underlined Laky.
Citeline is also developing a Diversity API, scheduled for release later this quarter, that will allow users to analyze specific ICD10 patient counts by age, race, and gender, for U.S. clinical researchers and organizations.
In addition, some additional development for the Diversity Module is slated for the coming months, including enhanced visualizations, enriched data sets, organization-level diversity insights, and non-U.S. patient landscapes.
Learn more about Citeline's Sitetrove by clicking here.
Citeline, a Norstella company, powers a full suite of complementary business intelligence offerings to meet the changing needs of life science professionals to accelerate connecting treatments to patients and patients to treatments.
These patient-centric solutions and services deliver and analyze data that is used to drive clinical, business, and regulatory decisions, thus creating real-world growth opportunities.