National Library of Medicine
Babrak L, Smakaj E, Agac T, Asprion P, Grimberg F, Van der Werf D, van Ginkel E, Tosoni D, Clay I, Degan M, Brodbeck D, Natali E, Schkommodau E, MIho E
ABSTRACT: Digital technologies are transforming the healthcare system. A large part of information is generated as real-world data (RWD). Data from electronic health records and digital biomarkers have the potential to reveal associations between the benefits and adverse events of medicines, establish new patient stratification principles, expose unknown disease correlations, and inform on preventive measures. The impact for healthcare payors and providers, the biopharmaceutical industry and governments, is massive in terms of health outcomes, quality of care and cost. However, a framework to assess preliminary quality of RWD is missing, thus hindering the conduct of population-based observational studies to support regulatory decision-making and real-world evidence (RWE).