Health inequalities are an enduring issue that can be exacerbated by clinical trial recruitment that does not reflect the heterogeneous patient groups most likely to use these technologies when approved in clinical practice. Can real-world evidence reduce these inequalities? Senior Research Principal Grammati Sarri thinks so. Here’s how:
What is real-world evidence (RWE)?
RWE refers to data collected outside of traditional clinical trials, including from electronic health records, claims, and patient-generated data, among other sources. And unlike data collected in clinical trials, RWE is typically gathered from a much larger and more diverse patient population and in more varied settings, which can increase its relevance to real-world clinical practice.
How can RWE help reduce health inequalities?
As Sarri outlines in her recently published article “Can Real-World Evidence Help Restore Decades of Health Inequalities by Informing Health Care Decision-Making? Certainly, and Here Is How,” for Frontiers in Pharmacology, there is now a large amount of data pulled from real-world sources on the disproportionately heavy disease burden faced by the most disadvantaged and marginalized members of society. This new wealth of knowledge is important because, typically, those recruited to participate in clinical trials – that is, wealthy, young, white male participants – not only do not provide an accurate reflection of the heterogenous populations receiving the intended treatments, but they also ultimately lead to skewed data.
“RWE has a great potential to reveal real-life patient experiences and is a necessary channel to shed light on understanding and addressing health inequalities in health technology development and assessment,” Sarri argues. “RWE can uncover not only heterogeneity in a technology’s clinical outcomes among patients in the real world but also identify access barriers that can enable healthcare decision-makers to create a more equitable healthy society.”
This can be achieved by ensuring diversity in data collection, better coding to capture sociodemographic data as well as by increasing incentives for RWE collection infrastructure in marginalized communities.
How can sponsors use RWE in clinical trials?
To improve patient diversity, a wide range of applications have been proposed to use RWE in clinical trials design such as in pragmatic clinical trials, target trial emulation, and applications of machine learning and artificial intelligence in predictive modeling and comparative effectiveness research.
Ultimately, including diverse populations in clinical research may lead to better, more robust data, greater equality, and, eventually, fewer disparities in health outcomes.
To read the full article, click here:
Grammati Sarri was recently interviewed by Inside Precision Medicine for “Improving Health Equity Starts with Real-World Evidence.” To read the interview, click here.
Read more from Perspectives on Enquiry & Evidence:
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FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
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