Going Virtual: Evolving Real World Evidence Study Design For Speed, Flexibility, & Lower Cost

Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites. We present the elements required to conduct prospective virtual RWE studies, including online patient recruitment, e-consent, patient-centric call center support, physician oversight, online questionnaires, and local lab testing. We also cover the elements needed to conduct retrospective virtual RWE studies using electronic data that can replace the need for an expensive prospective study. Both of these models show great promise in lowering the cost and improving the efficacy of current, site-based RWE studies.