Transferring Outcomes Data for National Decision Making: The Illusion of Simplicity - The whole world should use validated Swedish Data, or maybe not….
22 Oct 2019

This blog is part of our series on the issues related to the transferability of outcomes, for national decision making. You can follow this link to read our other blog posts on this topic.

The ongoing discussion about the use of Real-World Data as input into RWE studies for decision making can be summarized in these three points:

  • The data should be validated, with high quality and transparent
  • Applicable population
  • The appropriate comparator

Should this be the case, one could suggest that the whole world should be using Swedish data sources. These sources of data are quite likely to be among the best in class, in terms of quality and validity, as well as an applicable population at most times since it covers the whole population and not always the appropriate comparator.

Intuitively most of us would think that this is an ignorant proposition. What relevance would the Swedish data have for example in the US? Or maybe, even within Europe?

There are many research questions, where it is possible to transfer the results from a study in Sweden to other settings/countries. This is also recognized by FDA who use a Swedish example in their guidance document (Page 42):

Here is a listing of some of the validation / descriptive studies that exist for the national registries as well as the disease-specific registries. Frankly, there are very few datasets that can compare with this quality of data.

There are also many research questions, where the results are not transferable from a Swedish context to other countries due to the difference in health care delivery. See previous blogs on this topic.

Even though as a Swedish company, we would very much appreciate if it was that simple that the Swedish data had relevance for most types of research questions. However, we don’t think it is the case.

The richness and quality of the data deserve a much broader utilization, but the relevance to the country-specific questions from decision-makers should be carefully considered.

National Registries:

Disease-specific registries / questions