The human touch: the benefits of real world evidence

Listen to this article on the DDW Podcast: Lu Rahman looks at the growing role of real world evidence and its benefits in the fight against Covid-19. Real world evidence (RWE) is nothing new. While clinical trials have a significant part to play - and indeed remain the ultimate standard for advancing new drugs to markets - gathering observational data from clinical settings and humans in their everyday environments, has grown in importance. While it will not take the place of randomised clinical trials, the analysis and dissemination of RWE has becoming increasingly significant with the advent and rise of technology. Health / fitness devices, electronics patient records, health informatics and artificial intelligence have helped move data from person to clinician to researcher that has helped speed up the knowledge we hold on therapeutics and vaccines. And not only can RWE give us fast and accurate data on the efficacy and safety of a particular drug, but it also has potential for drug development, uncovering issues promptly, and facilitating data sharing and analysis for improved outcomes. We have seen the benefits of RWE as the Covid-19 vaccine has been rolled out globally. Thanks to a study of health care personnel, first responders, and other essential workers - who likely to be exposed to the virus because of their occupations- information was gathered that helped progress the knowledge we had on mRNA Covid-19 vaccines. This CDC study looked at the effectiveness of Pfizer-BioNTech and Moderna mRNA vaccines in preventing SARS-CoV-2 infections among 3,950 study participants in six states over a 13-week period from December 14, 2020 to March 13, 2021. Results found that following the second dose of vaccine, risk of infection was reduced by 90% two or more weeks after vaccination. Following a single dose of either vaccine, the participants’ risk of infection with SARS-CoV-2 was reduced by 80% two or more weeks after vaccination. Early on into the process, this information was valuable. The new vaccine effectiveness findings were found to consistent with those from Phase III clinical trials conducted with the vaccines before they received Emergency Use Authorizations from the FDA. Those clinical trials evaluated vaccine efficacy against Covid-19 disease, while this study evaluated vaccine effectiveness against infection, including infections that did not result in symptoms. According to CDC Director Rochelle Walensky: “The authorised mRNA Covid-19 vaccines provided early, substantial real-world protection against infection for our nation’s health care personnel, first responders, and other frontline essential workers.” Similarly, the Israel Ministry of Health (MoH), Pfizer and BioNTech also released RWE earlier this year demonstrating dramatically lower incidence rates of Covid-19 disease in individuals fully vaccinated with the Pfizer-BioNTech Covid-19 vaccine. Again, the benefit of the RWE was to underline the findings of the clinical trials. “We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase III clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to Covid-19,” said Luis Jodar, Senior Vice President & Chief Medical Officer, Pfizer Vaccines. In April this year, Ruth E Drury and Daniel O’Connor published a paper Symptom study app provides real-world data on COVID-19 vaccines1 which examined real-world data on Covid-19 vaccine “reactogenicity and SARS-CoV-2 infection in users of the COVID Symptom Study app”. Over 4·5 million UK contributors used the app to log their daily health status, test results, vaccine status, alongside demographic information and comorbidities. Users were also asked to log certain details eight days post vaccination. Among the findings was “analysis of SARS-CoV-2 test positivity in vaccinated and unvaccinated app users” which “showed that protection against SARS-CoV-2 infection appears as early as 12 days after vaccination”. This vaccine reactogenicity from use in the population was crucial information. RWE has clear benefits to the pharmaceutical sector, allowing it to understand the way a vaccine or drug may work / react in the wider population. Thanks to technology and our ability to disseminate data, these findings can be acted upon swiftly and collated with data from elsewhere on a global scale to create therapeutics and vaccines with the utmost efficacy and safety. An additional - and important benefit is that it may also help encourage vaccine uptake by those who are sceptical. Findings that come via the community may be viewed more favourably than findings from the pharma sector, even if the findings turn out to be the same. Volume 22, Issue 3 – Summer 2021 References https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00264-4/fulltext