ABSTRACT
PURPOSE: The demand for real-world data as supportive evidence to traditional clinical studies has increased in the past few years. The present study aimed to identify worldwide generic sources of real-world data and to assess completeness and suitability of selected real-world evidence (RWE) data sources to conduct prespecified research. METHODS: A systematic literature review was conducted to identify generic (non-disease specific) sources of real-world data in Medline and Embase from January 1, 2010 to September 8, 2015. Data sources used in observational studies were identified and summarized based on their geographical distribution and the type of data. In the next step, the selected data sources were critically evaluated for their completeness. RESULTS: A total of 10,069 identified publications were screened, leading to 2635 unique data sources across 102 countries. Europe had the maximum number of data sources (n = 1163) followed by United States (n = 578), and Asia, Middle East, and African Countries (n = 374). The most common type of identified data sources across all countries was structured data sources, ie, administrative databases and registries. Of the identified data sources, 300 were selected for further investigation. From the selected databases, ~50% had confirmed information on over 60% of the investigated variables, ~61% were suitable for epidemiological research, and 60% had possibility of linkage. CONCLUSIONS: The present study applied a systematic literature review approach and identified available generic sources of real-world data worldwide, in addition to the United States and Europe, which are suitable for conducting pre-defined researches and support future RWE studies.
