OBJECTIVES : To gain a deep understanding of the Real-World Data (RWD) landscape through characterizing and describing existing healthcare databases and identifying whether RWE is accepted for healthcare decision making in Latin America (LA).

METHODS : To identify and characterize RWD sources in nine countries targeting 18 therapy areas, three consecutive steps were undertaken: 1) comprehensive desk research using a variety of published sources and websites, 2) established and applied criteria to assess data quality, and 3) assessed the ability to address various research questions for data sources meeting pre-specified quality standards. Qualitative, in-depth interviews were conducted with payers and experts in RWD to determine ways that RWE is utilized in each country.

RESULTS : Ninety-eight high quality data sources were identified in total, including disease specific registries (26%), public surveys (16%), and electronic medical records (EMR- 16%). Brazil (17%), Chile (17%), Peru (13%), Colombia (12%), and Mexico (10%) accounted for most of these RWD sources. In general, LA countries have a fragmented RWD landscape due to different levels of healthcare systems governing RWD collection. However, there is an emergence of nationwide healthcare data management to collect and use RWD. Despite the existence of public surveys and disease specific registries across the region, the absence of sources with detailed information on patient reported outcomes is the biggest RWD gap observed. Survey respondents across most markets, indicated that RWE is used in decision-making both prior to approval of health care products, to a limited degree, and following market approval.

CONCLUSIONS : The Latin American RWD landscape is evolving. There is an increased drive to collect RWD nationally leading to greater availability of general population data sources for RWE research and to inform healthcare decision making.