OBJECTIVES : A lot has been published regarding real-world data (RWD) and evidence (RWE). Yet, uncertainty remains, with variations in how it is used to aid HTA decision making and reluctance of decision makers to accept it. This uncertainty may relate to its definition, understanding which RWD sources are acceptable and when, the questions each source can answer with confidence (termed ‘pairings’) and appropriate methods for collection and analysis per pairing. Our objectives are to define and clarify these uncertainties using a Taxonomy of RWD/E which can ultimately support HTA decision-makers regarding RWD/E in Europe.

METHODS : We conducted a review of reviews to build on RWD/E reviews published to date and understand where RWD/E has been used successfully (PubMed, TRIP). This is supported by a targeted review including key RWD/E initiatives (HTA websites, EUnetHTA, Google).

RESULTS : 127 studies were included in our qualitative synthesis. The literature retrieved tends to include a lot of blanket statements about RWD being or not being valuable which is misleading and not useful for HTA decision makers without the context. Variation in RWD/E definition mainly reflects an evolution and expansion of definition/sources/questions rather than just uncertainty and lack of agreement. We compiled a Taxonomy which begins to list all potential questions, examples of appropriate sources, positive (successful pairings) and cautionary (common problems) considerations and steps to minimise challenges. We propose a new RWD/E definition to reflect its evolution. RWD/E definition will continue to evolve particularly with advances in technology, methods, and capability to link data sets. Limitations include our search restrictions; however, our next steps include building on our Taxonomy using tailored searches per pairing.

CONCLUSIONS : We compiled a first draft of a RWD/E Taxonomy which ultimately can support HTA decision making.

This abstract has been created with the support and collaboration of Novartis Region Europe.