Researchers and decision makers have become increasingly aware that the experimental data alone are insufficient to address decisions fully.
Real World Data help to provide a more complete picture of care and have the potential to improve quality of care, also in terms of efficacy and safety of the treatments.
Annalisa Landi, researcher of Fondazione Gianni Benzi, is actively involved in activities related to the health data. She is member of the TEDDY Network Health data Working Group (WG) and in this framework, she collaborated with the WG 3 ‘Data Sources and Multi-source Studies’ of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) on the manuscript “Different strategies to execute multi-database studies for medicines surveillance in real world setting: a reflection on the European model” that was recently published on the Clinical Pharmacology & Therapeutics Journal.
The review describes the relevant role of the of post-marketing safety studies, in particular of the multi-databases studies, in providing more useful information on medicines safety. The role of post-marketing safety studies becomes even more important for an increasing number of medicines, such as orphan drugs, that are marketed through accelerated approval procedures before sufficient evidence of efficacy and safety is available. Although post-marketing studies conducted in population-based databases often contain information on patients in the order of millions, they can still be under-powered if outcomes or exposure of interest are rare, or when the interest is in subgroups. In such cases, combining several databases serves to provide the needed statistical power. Moreover, combining different databases is often necessary to gather evidence from different countries, both to study specific patterns of utilization and to produce evidence with more robust external validity. In addition, the review defines and compares the strategies that can be adopted to conduct these studies and analyses their potential implications from an European perspective.
Discover more on this topic by reading the article that you can find here.
More evidence for more efficient and safe medicines!