Epistemological Tensions in the EU HTA Joint Clinical Assessment: The Illusion of Judgment-Free Evaluation
Abstract
Health Technology Assessment (HTA) is shaped by moral (what makes a health technology desirable or acceptable, e.g., beneficence, justice), epistemological (how reliable knowledge is obtained and validated, e.g., evidence standards, uncertainty handling), and ontological (what effects and outcomes are considered real and relevant for assessment) commitments. The EU Joint Clinical Assessment (JCA), intended to harmonize relative effectiveness evaluation, embeds these commitments implicitly rather than explicitly, creating transparency and consistency issues. Critical concerns include: rigid reliance on the PICO framework privileging RCTs and quantifiable outcomes, proliferation of PICOs leading to infeasible evidence requirements, inadequate handling of multiplicity and post-hoc analyses, conflation of certainty and uncertainty, and exclusion of qualitative evidence and stakeholder input. Guidance documents, criticized for methodological weaknesses (e.g., outdated tools, poor external validity assessment, nominal p-values acceptance), further undermine epistemic robustness. These structural flaws risk producing assessments that are non-inclusive, reductionist, and epistemologically inconsistent. Future EU HTA frameworks should explicitly align on foundational commitments and integrate stakeholder perspectives to ensure transparency, scientific credibility, and ethical legitimacy.
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BibTeX
@article{toumi2026epistemological,
title = {{Epistemological Tensions in the EU HTA Joint Clinical Assessment: The Illusion of Judgment-Free Evaluation}},
author = {Mondher Toumi and Bruno Falissard and Asma Jouini and Imen Soussi and Steven Simoens and Maarten Postma and Laurent Boyer and Borislav Borissov and Renato Bernardini and Stefano Capri and Dávid Dankó and Frank-Urlich Fricke and Claude Dussard and Pascal Auquier},
journal = {Journal of Market Access \& Health Policy},
year = {2026},
month = jul,
doi = {10.3390/jmahp14030040},
url = {https://hal.science/hal-05748762v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Epistemological Tensions in the EU HTA Joint Clinical Assessment: The Illusion of Judgment-Free Evaluation
AU - Mondher Toumi
AU - Bruno Falissard
AU - Asma Jouini
AU - Imen Soussi
AU - Steven Simoens
AU - Maarten Postma
AU - Laurent Boyer
AU - Borislav Borissov
AU - Renato Bernardini
AU - Stefano Capri
AU - Dávid Dankó
AU - Frank-Urlich Fricke
AU - Claude Dussard
AU - Pascal Auquier
PY - 2026
DA - 2026/07/24
JO - Journal of Market Access & Health Policy
DO - 10.3390/jmahp14030040
UR - https://hal.science/hal-05748762v1
AB - Health Technology Assessment (HTA) is shaped by moral (what makes a health technology desirable or acceptable, e.g., beneficence, justice), epistemological (how reliable knowledge is obtained and validated, e.g., evidence standards, uncertainty handling), and ontological (what effects and outcomes are considered real and relevant for assessment) commitments. The EU Joint Clinical Assessment (JCA), intended to harmonize relative effectiveness evaluation, embeds these commitments implicitly rather than explicitly, creating transparency and consistency issues. Critical concerns include: rigid reliance on the PICO framework privileging RCTs and quantifiable outcomes, proliferation of PICOs leading to infeasible evidence requirements, inadequate handling of multiplicity and post-hoc analyses, conflation of certainty and uncertainty, and exclusion of qualitative evidence and stakeholder input. Guidance documents, criticized for methodological weaknesses (e.g., outdated tools, poor external validity assessment, nominal p-values acceptance), further undermine epistemic robustness. These structural flaws risk producing assessments that are non-inclusive, reductionist, and epistemologically inconsistent. Future EU HTA frameworks should explicitly align on foundational commitments and integrate stakeholder perspectives to ensure transparency, scientific credibility, and ethical legitimacy.
SN - 2001-6689
ER -