Il ruolo dei Real World Data (RWD) nell’Health Technology Assessment (HTA). La lezione della filosofia della scienza e del Progetto VALIDATE

[Autom. eng. transl.] Background It is often stated that HTA owes much of its success to the link with Evidence-based Medicine (EBM), an approach to medicine that places emphasis on a particular type of "evidence", that is, the one coming from it from randomized trials (RCTs) and systematic reviews. In recent times, however, the processes of HTA they increasingly seem to incorporate data from non-randomized and Real studies into evaluations World Evidence. Is this a worrying phenomenon? Is the HTA lowering the quality of its investigations? THE HTA reports necessarily need data from RCTs and systematic reviews for be realized? Objectives of the work The goal of the work is to try to provide an answer to these questions. In particular, the goal is that of making explicit, from an epistemological point of view, the role that non-randomized studies and RWDs play they can perform in HTA processes. Work methodology The analysis will be conducted through a process of reviewing the main conclusions reached today's epistemology of science on the topic of evidence and their application to the field of HTA as part of the VALIDATE project (VAlues in Doing Assessments of healthcare Technologies). The latter is a research funded by the European Union under the Erasmus + program for the training of next generation of HTA experts. For the analysis, the authors of reference will be those who have contributed, in various ways, to the overcoming of the so-called dichotomy "facts-values" as Popper, Khun, Duhem, Quine, Gadamer, Habermas and Putman. Conclusions Randomized and RWD trials do not pose a threat to HTA. The issues accompanying the their use is not a matter of legitimacy but of relevance.