External challenges for the acceptance of RWE

External challenges for the acceptance of RWE - Richard White

11:35 AM - 12:30 PM


The use of Real-World data (RWD) to derive real-world evidence (RWE) is not a new concept! Since already several decades, RWE is used mainly by regulators to answer safety questions, and to some extent also by Health Technology Assessment (HTA) bodies and payers. But now that the scope of possible use of RWE is expanding, there are quite some challenges to overcome if we want RWE to be accepted by different stakeholders. Below is a list that will be the basis of the presentation:
- The first hurdle is linked to the lack of randomization and the risk of bias inherent to all observational (non-randomised) studies;
- Another critical one is the quality of the RWD which are used to derive the RWE. This includes several aspects like data completeness and accuracy, but not only;
- The generalisability of the results, also linked to the representativeness of the RW population assessed, is also often perceived as one challenge;
- Finally, the transparency is a critical point to ensure robust RWE. This is also closely related to conflicting results that can be sometimes observed, coming from different studies, data sources, methods…
Many position papers from regulators, or scientific societies have been released recently that address this topic. We will give an overview as well as some recommendations that may ease the acceptance of RWE.