OBJECTIVES: Under right conditions Real-World-Data can support Real-World-Evidence by constituting valid scientific indication for regulatory decision-making. A literature review was conducted to determine the RWD and RWE state of art.

METHODS: Medline/PubMed database was investigated to include hints reporting the words RWD or RWE. Search string, released on 9^th January 2018, was defined to include articles published up to 2017. All retrieved articles were assessed and selected based on information included in the title/abstract. There were no restrictions on language, year of publications, and type of reference. Data were collected following an extraction plan which included: ID, first author, year, journal, affiliation, type, topic, and type of RWD source.

RESULTS: Data on 395 abstracts, published from 1991 to 2017, were collected and cleaned. Data on 381 abstracts were analyzed; 14 references using RWD/RWE as biologic or genetic term have been excluded. 38.5% articles where published in the 2017 (median 2016; interquartile range 2015-2017). First author affiliations were: 189 (49.6%) European (United Kingdom 13.1%, Italy 8.9%, Germany 6.3%), 106 (27.8%) Americans, 61 (16%) Asiatic and 6 (1.6%) Australian. Most of articles concerned drugs (clinical study 32.8%, review article 15.7%, comments/reply/editorial 10.2%) whereas 5 (1.3%) were about device. Topics of major interest were oncology (17.6%), cardiovascular (15.5%), endocrinology (9.4%). Articles were published by school/university (29.9%), sponsors (24.7%), hospital/care institute (20.5%). Information on data source is reported in 137 (63%) (electronic records 20.2%, registries 8.4%, claim data 4.2%); of these 6.6% specified more than one source database (range 1-5).

CONCLUSIONS: The usage of RWD has grown exponentially in the last 30 years thanks to the evolution of technological tools that has made this information more accessible. European researchers are the most interested. Oncology and cardiovascular drugs are the principal fields of application. Electronic medical/health records remain the main type of source used.