Clinical Trials Evidence Gaps: A Need for Real World Evidence Informed by Digital Technologies
Turning real-world data, a vast repository gathered from multiple sources, into usable real-world evidence requires the use of methodologies that appropriately fit the purpose. As noted by Scott Gottlieb, the US FDA Commissioner in September, “We need to close the evidence gap between the information we use to make FDA’s decisions and the evidence increasingly used by the medical community, by payers, and by others charged with making healthcare decisions,”
Thus Real World Evidence (RWE) studies are being looked at as a means to supplement data obtained in randomized controlled clinical trials by filling in critical evidence gaps surrounding how well treatment interventions work in typical health care settings. RWE will also inform tangible actions to be taken to better manage efficiency and effectiveness of health care delivery. Mobile platforms and digital technology will be an integral part of RWE strategies, as they offer the means to understand patient co-morbidities associated with disease, patient adherence and compliance to drug treatment and the differences between interventions’ performance in a broader population versus the context of clinical trials.