OBJECTIVES: In recent years, ‘real world evidence’ (RWE) has become an increasingly popular term, despite a lack of consensus on its definition. RWE has been adopted as a form of clinical evidence that informs how a drug is used and the benefits gained outside of clinical trials. This research aimed to assess the use of RWE across disease areas and to identify any trends in the use of RWE within the scientific literature.

METHODS: A retrospective analysis was conducted using the online database PubMed. Key search terms were used to (a) identify RWE publications dated between January 1, 2012, and May 31, 2018, within key disease areas (cancer, cardiovascular, and rare diseases), and (b) further subdivide the publications identified by type of study (pragmatic, observational, database, registry, and other).

RESULTS: The initial broad search revealed that cancer had the most publications, with a total of 1,030,609 hits, followed by cardiovascular at 395,848, and rare diseases with 91,356. In 2017, of the total publications across the three disease areas, only 0.35% (881/245,575) utilized RWE, and cardiovascular was more likely than cancer or rare diseases to feature RWE in publications (2017: 0.58% vs. 0.29% vs. 0.24%). When considering study types utilizing RWE over the period searched, the most common type for each disease area varied broadly; database was the highest for cancer, observational for rare diseases, and registry for cardiovascular. Year-on-year analysis revealed that publications utilizing RWE became more frequent across the three disease areas between 2012 and present.

CONCLUSIONS: Across all three disease areas, RWE publication over time was consistent or increasing. The number of papers reporting RWE remains low, which may be reflective of the lack of guidelines for reporting, and variability in the definition of RWE. Further consensus would aid the acceptance of RWE as supportive evidence.