On the normativity of evidence – Lessons from philosophy of science and the “VALIDATE” project

P. Refolo, D. Sacchini, B. Bloemen, J. Grin, I. Gutierrez-Ibarluzea, B. Hofmann, W. Oortwijn, C. Raimondi, L. Sampietro-Colom, L. Sandman, G.J. van der Wilt, A.G. Spagnolo

Research Center for Clinical Bioethics and Medical Humanities, Università Cattolica del Sacro Cuore, Rome, Italy. dario.sacchini@unicatt.it

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• Bioethics

“Evidence” is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation. One of the principal misunderstandings is to consider RCTs findings as isolated and self-apparent pieces of information. In other words, what has been essentially lacking was the awareness of the value-context of the evidence and, in particular, the value- and theory-ladenness (normativity) of scientific knowledge.

This paper aims to emphasize the normativity that exists in the production of scientific knowledge, and in particular in the conduct of RCTs as well as in the performance of HTA. The work is based on some lessons learned from Philosophy of Science and the European project “VALIDATE” (VALues In Doing Assessments of healthcare TEchnologies”). VALIDATE was a three-year EU Erasmus+ strategic partnerships project (2018-2021), in which training in the field of HTA was further optimized by using insights from political science and ethics (in accordance with the recent definition of HTA). Our analysis may reveal useful insights for addressing some challenges that HTA is going to face in the future.

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