OBJECTIVES: Real World Evidence (RWE), emerging from real world data (RWD) outside clinical trials, has been under focus due to its potential role to improve quality of the results while containing health care costs. In spite of its growing interest in Latin America (LATAM), significant gaps are still being seeing, compared to other regions in the world. This research aims to describe the understanding of RWE by key stakeholders in LATAM and how RWE is being applied in the decision-making process. Finally, it wants to point opportunities and challenges for its implementation.

METHODS: This project is being conducted by the ISPOR Latin America Consortium RWE Working Group and the University of Cincinnati. A survey gathered from previous literature search was adapted and translated into Spanish and Portuguese, then was submitted through an electronic tool (Surveymonkey ®) in order to capture health systems key stakeholders and health technology assessment (HTA) organizations perception and knowledge about RWE and identify challenges and opportunities around their implementation. Additionally, a published and gray literature search of relevant HTA and economic evaluation guidelines referring to RWE/RWD in Latam will be conducted.

RESULTS: Data will be collected between May 6 and September 1, 2019. Descriptive statistics will be reported for geographic distribution, work affiliation by institution type, etc. Agreement with common RWE/RWD definitions, RWE/RWD experience and opportunities and challenges will be summarized. Open-ended questions data will be evaluated using qualitative data analysis techniques.

CONCLUSIONS: This research will yield a deeper understanding of the current landscape of RWE/RWD in Latam. This work will provide a more defined and updated view of RWE in Latin America to benefit future activities shaping RWE in the region. Findings will build momentum to continue in-depth explorations about opportunities and challenges for RWE in Latam.