Pietro Refolo, Katherine Duthie, Björn Hofmann, Michal Stanak, Neil Bertelsen, Bart Bloemen, Rosella Di Bidino, Wija Oortwijn, Costanza Raimondi, Dario Sacchini, Gert Jan van der Wilt, Kenneth Bond
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Ethical challenges for Health Technology Assessment (HTA) in the evolving evidence landscape.
Since its inception, Health Technology Assessment (HTA) has typically determined the value of a technology by collecting information derived from randomized clinical trials (RCTs), in line with the principles of evidence-based medicine (EBM). However, data from RCTs did not constitute the sole source of information, as other types of evidence (such as primary qualitative research) have often been utilized. Recent advances in both generating and collecting other types of evidence are broadening the landscape of evidence, adding complexity to the discussion of "robustness of evidence." What are the consequences of these recent developments for the methodology and conduct of HTA, the HTA community, and its ethical commitments? The aim of this article is to explore some ethical challenges that are emerging in the current evolving evidence landscape, particularly changes in evidence generation and collection (e.g., diversification of data sources), and shifting standards of evidence in the field of HTA (e.g., increasing acceptability of evidence that is thought of as lower quality). Our conclusion is that deciding how to best maintain trustworthiness is common to all these issues.