Sponsors’ pharmacovigilance and medical affairs teams frequently gather RWD directly from medical sites for chart reviews, registries, and other observational studies. These sources have also become more attractive sources for RWD to supplement new indication applications, particularly under accelerated approval schemes for breakthrough therapies and orphan indications.5-7 The human effort and time investments for such data collection limits sponsors’ ability to conduct these studies at scale. However, the increasing global adoption of electronic medical records (EMRs) at clinical sites has prompted interest in using sites’ EMRs systematically for observational studies. The hope of sponsors is that sites can spend less time performing manual abstraction and resolving queries, leading to lower costs, faster data collection, larger sample sizes, and higher quality and accuracy.
Despite the attractiveness of EMR-based site studies, demand for such data frequently outpaces the data exchange technologies required to implement EMR data collection. Technology solutions are possible and are (at least partly) enabled by international data exchange standards implemented in most branded EMRs.8,9 However, through our experience implementing several EMR data collection studies at clinical sites, we have learned that operational issues can often pose greater barriers to EMR studies than the technology limitations. Stakeholders at clinical sites often lack knowledge and harbor reasonable apprehensions about providing access to EMR data, and their concerns have been amplified as sanctions have increased (and have been more widely publicized) following new privacy laws such as the 2018 European Union (EU) General Data Protection Regulation (GDPR). Implementing site-based EMR studies requires new collaborations and change management within clinical sites, and few have invested in changes to accommodate EMR data collection approaches. Here we present four key lessons for EMR studies that we have gathered through our experience working with sites in multiple countries.