Matthew W. Reynolds, Ph.D., vice president, scientific affairs, real world solutions, IQVIA, explains how RWE can provide a greater picture of a disease’s progression as well as a blueprint for future outbreaks.
Med Ad News: What role is real-world evidence (RWE) and patient-generated health data (PGHD) playing in the understanding of COVID-19 vaccine safety and efficacy? What critical insights can be gleaned?
Matthew W. Reynolds: While randomized controlled trials provide the initial core basis for the efficacy and safety of new vaccines for COVID-19, real-world data (RWD) offers additional insights post-launch of these products. It can present the opportunity to provide near-real-time insight into the population receiving the vaccine, medical comorbidities, healthcare utilization post-vaccination, any emergency visits or hospitalizations due to COVID-19 infection or their vaccinations, and more. Leveraging person-generated health data (PGHD) provides further detail into the impact of COVID-19 infection and associated vaccinations and is an additional level of information that is not available in traditional RWD sources (e.g., medical insurance claims or electronic health records [EHR]). The incorporation of PGHD allows patients to add their voice to highlight key information like the presence of specific COVID-19 symptoms and their severity, vaccine side effects and the impact on their quality of life. PGHD provides insight into what happens between medical visits, which is not normally or easily recorded in traditional RWD sources. Having this level of detail into the presence and severity of COVID-19 symptoms alone makes the inclusion of PGHD a necessity to conduct a high quality COVID-19 study.
Med Ad News: How is RWE and PGHD being leveraged to assist public health experts in understanding the factors in quantifying breakthrough infections, their severity, and vaccine effectiveness?
Reynolds: PGHD provides supplementary data to our go-to RWD sources such as EHR data. COVID-19 research is a challenging area for epidemiologists and clinical researchers because often the real-world patterns for testing, vaccination, and definition of outcomes are incomplete and lack detail from traditional RWD sources. With COVID-19, patients have access to at-home testing as well as testing via through public health departments, and other pop-up testing centers that don’t require any form of payment or tracking of medical and prescription insurance claims. The only way to obtain access to more comprehensive information on dates and results of COVID-19 tests and results is to ask the patient directly.
Similarly, there are challenges when trying to identify a patient’s COVID-19 vaccination history, since the first waves of boosters were primarily not captured in medical and prescription claims, as they were provided free of charge and often through mass vaccination sites that don’t contribute to traditional RWD sources. Hence, the use of RWD sources like medical and prescription claims would be incomplete in their capture of historical COVID-19 vaccinations and could cause critical flaws in studies that don’t address these challenges.
The occurrence of a COVID-19 infection may be picked up in traditional RWD if it resulted in a clinical office interaction, but there are likely a sizable portion of infections that were confirmed via home test. These patients self-quarantine at home with no provision of their infection or treatment data into an EHR or medical claim database. PGHD provides the ability to capture this information and other clinical details such as symptom presence, symptom severity, symptom resolution, and other factors. Leveraging PGHD – as we did in the CARE registry through asking thousands of participants to self-report their symptoms, symptom severity, medication usage and other factors – could assist in assessing vaccine effectiveness, the risk of breakthrough infections and COVID-19 severity in patient populations of special interest (e.g., pregnancy, immune-compromised, etc.). This is information that could not be assessed as completely and accurately via traditional core RWD sources.
Med Ad News: How is RWE being used to gain information about infectious disease outbreaks?
Reynolds: The proliferation of greater foundations for data sharing through global collaborations like that of IQVIA and the NBA, who created a comprehensive testing program in the NBA Bubble in 2020 and have continued to monitor the health and safety of players and staff have had a profound impact on our knowledge of COVID-19 and future outbreaks. This surveillance testing offered data than many other studies hadn’t, in capturing both symptomatic and asymptomatic infections. Some of the findings have had real-world implications, such as how long people can shed COVID-19 virus, if people with asymptomatic infections are less likely to transmit COVID-19 and whether boosters really work. RWE evidence platforms like this that gathered information about COVID-19 infection symptoms and vaccination symptoms in large populations have provided a greater picture of the disease’s progression, as well as a blueprint for future outbreaks.
|Maria Fontanazza is the director of content, Med Ad News and PharmaLive.com|