Dr. Diana Brainard, Senior Vice President and Virology Therapeutic Area Head at Gilead Sciences, provides her thoughts on the role of RWE (real world evidence) during the COVID-19 pandemic and how it’s forever changed the drug development landscape. Thanks to RWE, Gilead has been able to analyze valuable data on remdesivir, adapt to these findings, and partner with other groups through the COVID-19 Evidence Accelerator, among other important moves. Dr. Brainard notes that RWE allows pharma companies to recruit diverse populations by making telemedicine possible and convenient.
Dr. Brainard remarks, “[W]e need to start educating the public about RWD analyses, pragmatic trials, and vaccine trials, and lay the groundwork now before we have results to share. Identifying eligible patients in RWD is not as straightforward as it sounds, so we should communicate the meaning of inclusion and exclusion criteria, the importance of following good clinical practice, and other factors that inform the quality of the data.” She adds, “[I]f we’re able to work as an industry to validate real-world endpoints, we can help make the data useful from a regulatory standpoint.” Read more here.
(Source: HealthVerity, 2021)