Healthcare data solutions to address diversity challenges in clinical trials
Healthcare organizations experience diversity challenges in clinical trials. It is important to know strategies to better engage community care centers, systems to prioritize outreach, and modernized compliance processes.
Once considered novel, it is now widely accepted that Social Determinants of Health (SDoH)—such as financial stability, health literacy, race, and ethnicity—influence up to 80% of health outcomes.1 To date, most initiatives to attenuate the impact of SDoH have been led by health systems or health plans, emphasizing improving access, addressing quality disparities, supporting population management, and informing the point of care.
But life sciences firms also have a role to play, particularly in addressing the underrepresentation of diverse populations in clinical trials. Clinical Trials are often not accessible in many communities that could provide an eligible and diverse patient base. Beyond the obvious human impacts, there are downstream negative impacts to a drug’s market access, comparative effectiveness, and patient starts/adherence. Said another way, as long as access is constrained and effectiveness is variable, both patient outcomes and life sciences revenues will suffer.
While some progress has been made, underrepresentation of diverse communities in clinical trials continues. This is due to recruitment challenges, poor investigator coverage, trial awareness in many communities, friction in obtaining informed consent, legacy approaches to data collection, and manual/slow data governance. To improve trial representation, each much be addressed.
In this white paper, we explore the three dimensions of the underrepresentation in clinical trials, its cascading effects, why it continues to exist, and steps sponsors and healthcare organizations (HCOs) can take to mitigate it. Sponsors need strategies to better engage community care centers, data/systems to prioritize outreach to them, and modernized compliance processes, particularly regarding privacy and ethical/fairness. HCOs, particularly those in community care settings, should explore advanced treatment strategies such as automatically matching patient medical records to pertinent clinical trials inclusion criteria and leveraging supplemental resources to engage trial candidates on their behalf.