Mordin M, Castro C, Buck PM, Fernandez MM, Hollis KA, Ritchey ME. European “real-world” evidence for drugs and devices: 2017 literature reviewed. Poster presented at the 2018 ISPOR 21st Annual European Congress; November 13, 2018. Barcelona, Spain.

OBJECTIVES: We evaluated RWE publications to understand whether studies from Europe are similar to the rest of the world (ROW).

METHODS: We reviewed English language 2017 titles and abstracts in Pubmed and Embase; searching for the term “real world.” The following elements were extracted: country, therapeutic area (TA), exposure type, study design, primary outcome, and data source. Descriptive analyses were performed.

RESULTS: There were 1045 hits for “real world” publications in 2017. Of these, 315 were excluded because they lacked an abstract (n=93) or were not related to provision of health care (n=222); 730 remained. Of these, 274 did not identify country of study and were excluded from further analyses (N=456). Data were from Europe in 42.5% (n=194) of studies. Regardless of region, most studies were retrospective (72.8%) and evaluated drugs (69.7%). Data sources were similar in Europe and ROW (medical records: 39%; 32%; primary data: 25%; 23%). European studies were more likely to utilize registries (18%) while ROW used claims (23%). Top 3 TAs were similar across regions (Europe; ROW): cardiovascular (21.1%; 22.5%), oncology (21.1%; 21.4%) and infectious disease (10.8%; 16.4%). Drug studies were mostly retrospective; used medical records, primary data collection, or claims data; evaluated effectiveness or treatment patterns; and the top TA was oncology. Device studies were mostly retrospective; used a data source of medical records, registry, or primary data collection; evaluated effectiveness or safety; and top TA was cardiovascular. Compared with ROW, studies in Europe were more likely to use registries and were less likely to assess infectious disease exposures. Otherwise, RWE in Europe was similar to ROW.

CONCLUSIONS: Over 40% of RWE literature was from Europe. While there were similarities in design and exposure, differences were noted in data sources. This was due to increased reliance on registries in Europe versus claims data in ROW.

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