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Patients seek healthcare services for a variety of reasons in a variety of settings. No matter where or why it occurs, every interaction presents an opportunity to collect important information on the patient journey — from symptoms to diagnosis, therapy, and recovery — via electronic medical records, claims data, lab results, and pharmacy records, among other data sources.
When aggregated and analyzed across large populations, this real-world evidence (RWE) about patient journeys is immensely powerful. It’s already being used to support drug discovery, patient recruitment for clinical trials, submissions to regulators, and more. Looking ahead, there’s huge opportunity to use RWE as input to digital health algorithms and, in combination with genomic and proteomic data, precision medicine.
Yet there’s an important and well-recognized weakness in the current state of RWE. Today, most patient journey data is derived from North America and Western Europe, where Caucasian people make up the majority of the population. In other words, there is very limited availability of RWE from non-white populations. Indeed, RWE from Latin America, Africa, and most of Asia is very difficult to find, costly to access, and very often lacks depth and quality, as well as longitude. Most of humanity is presently excluded from medical research based on the availability of real-world evidence.
A world of difference
Research consistently affirms racial and ethnic differences in gene expression and gene expression profiles that directly impact how treatment plans, therapies, and drugs are administered. Even when adjusting for social and environmental factors, these genetic differences impact which treatments will be most effective, and ultimately, determine the quality and length of a patient’s life.
Even the way drugs are metabolized can vary by race or ethnicity[iv] — a finding that contributed to the U.S. Food & Drug Administration issuing formal guidance[v]in 2020 on the need to increase diversity in clinical trial populations.Further draft guidance issued in April 2022[vi] spurred U.S. lawmakers to go a step further in December making diversity action plans a statutory requirement for FDA clinical trials[vii], which may finally lead to more representative research. These efforts are admirable and worthwhile, and yet, even if the U.S. succeeds in achieving appropriate diversity in clinical trials, RWE will still fall short at the global level.
This needs to change.
Healthcare studies will continue to be biased unless and until we have reliable channels for collecting, aggregating, and analyzing data on the journeys of all patients. It’s time to put the world in real-world evidence in order to be true to a vision of global health equity. In an upcoming post, I’ll explore the important role that global hospitals can play in supporting that vision.
George Zarkadakis, PhD is Chief Innovation Officer at Syndesis Health. He is the author of 11 books, and has published multiple articles on healthcare, AI and innovation in the Harvard Business Review, The Washington Post and many other periodicals.
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