Pioneers already utilise real-world evidence actively
The results of studies based on real-world data (RWD) have convinced also people that were previously hesitant.
Years ago, some pharmaceutical companies may have tried studies based on RWD in the spur of novelty and excitement. Novelty is, however, no longer enough. Currently, pharmaceutical companies utilise real-world evidence (RWE), that is, accumulated from data retrieved from various health- and socialcare registers, in a determined manner for specifically defined purposes.
– Pioneer companies in the pharmaceutical industry utilise RWE both in market access and many phases during the life cycle of a medicinal product, tells Medaffcon’s RWE Lead Mariann Lassenius.
According to Medaffcon’s experience, some of the actors in the pharmaceutical industry were previously sceptical towards RWE. They questioned, for example, the coverage and reliability of the material and the possibilities to utilise the research results.
However, experiences in RWE projects have also convinced the sceptics.
– They have seen that RWE studies work. The data is reliable and usable from the perspective of both clinicians and authorities. Some of the sceptics have become the most vocal advocates of RWE studies, states Medaffcon’s Managing Director Jarmo Hahl.
The benefits of the studies become clear quickly
From the perspective of authorities, RWE studies complement clinical trials and support decision-making by producing knowledge about the local situation in Finland.
According to Fimea’s Head of Assessment, Vesa Kiviniemi, RWE is useful in Fimea’s assessments in situations, where one should make indirect comparisons with existing treatments or use so-called maic comparison (matching-adjusted indirect treatment comparison). RWE is also useful when data on the progression or prognosis of a disease with current treatment is needed without the assessment of a medicinal product.
Experts at Medaffcon have observed that big part of the companies that have commissioned RWE studies want to do it again.
– You sort of get addicted to RWE studies as you note that the results are important for authority decision-making and support the market access of the medicine. With the studies, companies can also provide clinicians with resources in interesting research topics, states Medaffcon’s Access & HE Lead Tatu Sainio.
High-quality and interesting RWE studies may also be a manner for a Finnish country organisation of a pharmaceutical company to demonstrate their innovativeness for the global organisation.
– The studies may contribute to demonstrating their activity and to becoming a standard-bearer within the company. The studies can constitute a whopping, forward-taking issue from the perspective of the entire organisation. An RWE study completed in Finland may result in a global organisation becoming interested in Finnish expertise and data, tells Jarmo Hahl.
Read more about Medaffcon’s RWE studies and services.