The patient as sub-investigator

Abstract

Abstract Empowering patients to collect their own trial data, more or less in the role of sub-investigators, offers an increasing opportunity to gather rich primary electronic source data directly, thereby displacing some of the traditional activities in trial sites for many trials. This is most obvious in chronic diseases. It should cause us to reevaluate what and how data are gathered in trials. We should start the management of change toward centralized monitoring of subjects, as well as of quality compliance. We can minimize the need for on-site monitoring and maximize business continuity during crises. We can greatly cut the cost of irrelevant activity and data that do not contribute to trial outcomes. We can start treating trial participants less as subjects and more as real stakeholders.