There has been expansion in the size and types of databases available; therefore, the term "big data" often is used when referring to some RWD sources.
Other uses and benefits of RWD are shown in TABLE 2.
There is no universally accepted definition of RWD. In its broadest terms, RWD refers to data obtained outside of an RCT.
(21) The collection and analysis of RWD can be costly.
The challenges presented with the limitations of RWD are a focus of active efforts by the FDA, National Institutes of Health, pharmaceutical manufacturers, and other stakeholders.
An early example of how RWD can lead to practice change involves the use of beta-blockers in patients who had experienced a myocardial infarction (MI).