REAL WORLD RESEARCH IN LATIN AMERICA- OPPORTUNITIES, SOURCES AND BARRIERS
Author(s)
Gregory V1, Barbeau M1, Machnicki G2, Voko Z3, Heisel O4, Keown P4
1Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada, 2Novartis Argentina SA, Buenos Aires, Argentina, 3Syreon Research Institute, Budapest, Hungary, 4Syreon Corporation, Vancouver, BC, Canada
OBJECTIVES: Real world evidence (RWE) is critical for the assessment of health technologies. This study was conducted to define and compare the governance of, and data sources available for, real world research (RWR) in Latin America (LA) and Canada. METHODS: Systematic literature review was conducted to examine administrative and clinical data for 10 major countries ranked by population. Research terms were defined by an international team, and reports were reviewed and assessed for content, quality and bias by two investigators. Data was summarized in major and minor domains for each country. RESULTS: Governance of RWR differed between countries, both from a regulatory and an ethics committee review perspective. Regulatory review was required for non-interventional studies in 4/10 countries. Ethics review varied importantly in complexity, site (local, central) and duration (which could exceed 1 year). Administrative and clinical search terms returned over 1800 reports from LA, principally from Brazil, Mexico, Argentina and Chile, of which over 700 contained contributory information on data sources for RWE. Of these, 156 addressed international registries or databases including countries in LA, 245 reported national registries or databases within one country in LA, and 308 reported registries or databases from a single or multiple institutions within a country. Principal administrative categories included claims, prescription and economic data sources, while principal clinical categories included data sources relating to cancer, cardiology, neurology, respirology, and diabetes. In contrast, a total of over 2000 reports were obtained for Canada alone, with a similar categorical distribution to that observed in LA. CONCLUSIONS: Latin America is a region with diverse health systems, inputs and outcomes. While sources for RWE exist in several larger countries, comprehensive national or regional databases are uncommon compared with a mature public healthcare system such as Canada. Improvement of database quality and well-designed prospective population studies are critical to enhance the RWE base.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PRM43
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Multiple Diseases