Real-life data and evidence in health technology assessment: when are they complementary, substitutes or the only source of data compared with clinical trials? - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Therapies Année : 2023

Real-life data and evidence in health technology assessment: when are they complementary, substitutes or the only source of data compared with clinical trials?

Résumé

Within the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process.

Dates et versions

hal-04194590 , version 1 (03-09-2023)

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Citer

Gerard De Pouvourville, Xavier Armoiry, Aurelie Lavorel, Pascal Bilbault, Philippe Maugendre, et al.. Real-life data and evidence in health technology assessment: when are they complementary, substitutes or the only source of data compared with clinical trials?. Therapies, 2023, 78 (1), pp.81-94. ⟨10.1016/j.therap.2022.11.001⟩. ⟨hal-04194590⟩
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