Therapie最新文献

{"title":"Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality","authors":"Guillaume L. Martin,&nbsp;Louis Létinier","doi":"10.1016/j.therap.2025.10.001","DOIUrl":"10.1016/j.therap.2025.10.001","url":null,"abstract":"<div><div>The integration of artificial intelligence (AI), particularly large language models (LLMs), into clinical prescription practices represents a transformative shift in healthcare, promising to offer enhanced therapeutic precision, reduced errors, and personalized care. However, rapid adoption is outpacing validation and governance. This narrative review critically examines the benefits, risks, and implementation challenges of AI in pharmacology, with an emphasis on prescribing use cases, highlighting the rapid adoption driven by physician constrained time and increasing complexity of medical knowledge, yet outpaced by validation frameworks. Key benefits include optimized decision support, as suggested by real-world systems like the Penda Health AI Copilot. However, inherent risks such as hallucinations, lack of explainability, spending inflation, and clinical de-skilling pose significant threats, potentially eroding trust and patient safety. We contrast regulatory philosophies [European Union (EU) precaution under the medical devices regulation (MDR) and AI Act vs U.S. flexibility via Food and Drug predetermined change control plans (FDA PCCP)] and spotlight a persistent grey zone in which general-purpose LLMs are used clinically without medical-device oversight. To operationalize trustworthy use, we foreground rigorous evaluation and outline an “architecture of trustworthy clinical AI” (retrieval-augmented generation, structured clinical prompting with abstention/uncertainty, and hybrid LLM–rule safety layers). Finally, we propose an outcomes-first paradigm adapted from French health technologies assessment (HTA) — service rendered by AI (SR-AI) and improvement of service rendered by AI (ISR-AI), with patient outcomes and system resilience as primary endpoints — and recommend a default stance that any generative AI used in health be treated as a medical device, with general-purpose LLMs permitted only via certified clinical wrappers that close the MDR-inconsistent gap.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 2","pages":"Pages 132-139"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147555106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital pharmacological twins: Bridging multi-scale modelling and artificial intelligence for precision medicine: The DIGPHAT consortium","authors":"Jean-Baptiste Woillard ,&nbsp;Sébastien Benzekry ,&nbsp;Julie Josse ,&nbsp;Mélanie White-Koning ,&nbsp;Etienne Chatelut ,&nbsp;Emmanuelle Comets ,&nbsp;Florian Lemaitre ,&nbsp;Bénédicte Franck ,&nbsp;Matthieu Gregoire ,&nbsp;Françoise Stanke-Labesque ,&nbsp;Sarah Zohar ,&nbsp;Moreno Ursino ,&nbsp;Christophe Battail ,&nbsp;on behalf of the DIGPHAT consortium","doi":"10.1016/j.therap.2025.09.006","DOIUrl":"10.1016/j.therap.2025.09.006","url":null,"abstract":"<div><div>The advent of digital twins in pharmacology presents transformative potential for precision medicine, enabling personalized treatment optimization through dynamic computational simulations of drug interactions at molecular, cellular, and patient levels. These advanced virtual replicas of a patient's biological system are designed to predict individual therapeutic responses with high fidelity, thereby moving beyond the one-size-fits-all paradigm. This paper explores the concept of digital pharmacological twins, detailing how they can integrate heterogeneous data, including multi-omic, pharmacokinetic, pharmacodynamic, clinical, and environmental information, and employing a synergy of advanced mechanistic and machine learning models. Using illustrative examples from ongoing international initiatives, this work highlights the methodological frameworks necessary for developing and validating such comprehensive predictive tools. We underscore the critical importance of model interoperability, robust data integration strategies, and rigorous validation to ensure clinical utility. Ultimately, digital pharmacological twins promise to enhance therapeutic efficacy, minimize adverse drug reactions, and accelerate the translation of pharmacological science into tangible patient benefits.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 2","pages":"Pages 147-158"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145275979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A new chapter in pharmacology: Artificial intelligence's expanding role in pharmacokinetics, pharmacodynamics, and pharmacovigilance","authors":"Alexandre O. Gérard ,&nbsp;Romain Lombardi ,&nbsp;Diane Merino ,&nbsp;Charles Bouveyron ,&nbsp;Jean Dellamonica ,&nbsp;Milou-Daniel Drici ,&nbsp;Thibaud Lavrut ,&nbsp;Alexandre Destere","doi":"10.1016/j.therap.2025.09.002","DOIUrl":"10.1016/j.therap.2025.09.002","url":null,"abstract":"<div><div>In recent years, artificial intelligence (AI) has emerged as a powerful tool in healthcare and is becoming increasingly prevalent across all medical and paramedical disciplines. AI has numerous applications in pharmacology. This narrative review explores the increasing importance of AI in three key areas of pharmacology: pharmacokinetics (PK), pharmacodynamics (PD), and pharmacovigilance (PV), as well as pharmacology education. We conducted a literature review enhanced by the ARTIREV hybrid bibliometric tool to identify and analyze key advances, applications, and challenges with AI integration in this field. In PK, machine learning and hybrid approaches improve the prediction of individualized drug exposure, support model-informed precision dosing and handle irregular and sparse data through architectures such as recurrent neural networks and NeuralODEs. In PD, AI facilitates a shift towards an era of precision and personalized medicine by enabling the development of drug effect models and considering interindividual variability. It also makes it easier to implement adaptive dosing regimens that are tailored to various constraints. Regarding PV, AI enhances the detection of adverse drug reactions, the identification of safety signals at the population level and the assessment of preclinical toxicities through the analysis of unstructured data, particularly from electronic health records. Despite their potential, AI models face several significant limitations. These include the quality of training data, limited explainability due to the “black box” effect and a lack of external validation of the models developed. Altogether, this review emphasizes the role of AI in pharmacology and the necessity of training future professionals to ensure the safe and validated use of AI in personalized medical applications.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 2","pages":"Pages 159-170"},"PeriodicalIF":1.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145303627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accelerating recruitment in clinical trials: A strategic challenge","authors":"Dominique Deplanque ,&nbsp;Ariane Galaup ,&nbsp;Christine Trillou ,&nbsp;Philippe Barthélemy ,&nbsp;Arnaud Bayle ,&nbsp;Lionel Da Cruz ,&nbsp;Erik Domain ,&nbsp;Michael Duruisseaux ,&nbsp;Cécile Fouret ,&nbsp;Laetitia Gambotti ,&nbsp;Cécile Girault ,&nbsp;Damien Gonthier ,&nbsp;Aurélie Guérin ,&nbsp;Antoine Hommais ,&nbsp;Jean-Sébastien Hulot ,&nbsp;Dorothée Ko ,&nbsp;Marie Lang ,&nbsp;Vincent Laugel ,&nbsp;Bruno Laviolle ,&nbsp;Christophe Le Tourneau ,&nbsp;Jérémy Skrzypski","doi":"10.1016/j.therap.2025.11.008","DOIUrl":"10.1016/j.therap.2025.11.008","url":null,"abstract":"<div><div>Clinical research provides an important gateway to therapeutic innovation and, in many cases, national participation in trials can facilitate the future availability of new treatments in the country concerned. Clinical research activity in general is declining in France, especially in terms of industry-led trials; the only exception being early-phase cancer trials. There is an urgent need to boost the level of French participation in major international trials, although this will require a marked improvement in recruitment performance. Although the many factors contributing to the mediocre performance of France merit discussion, the overriding necessity is to bring forward solutions for increasing the level of participation in clinical trials going forward. It is against this background that we propose these recommendations for facilitating and increasing overall enrolment. There are a number of potential ways in which improvements could be achieved, beginning with identifying eligible patients and offering them the opportunity to take part in clinical trials, either through greater engagement by healthcare professionals or the development of decentralised trials. Other opportunities include optimising territorial coverage through inter-hospital networks or clinical trials centre networks, strengthening and improving clinical trials centre organisational structures by introducing AI-driven patient pre-screening tools, and lastly reprofiling some of the roles involved in clinical research and the provision of associated training. While some of these recommendations require regulatory changes, the majority could be implemented immediately, and would provide a rapid response to this major strategic challenge.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 31-41"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How can the level of health product education (literacy) be raised among the general public?","authors":"Clara Locher ,&nbsp;Nathalie Manaud ,&nbsp;Mathieu Molimard ,&nbsp;Catherine Cassé-Perrot ,&nbsp;Jean-Luc Cracowski ,&nbsp;Cyril Di Palma ,&nbsp;Luc Duchossoy ,&nbsp;Chantal Gatignol ,&nbsp;Anthony Goldgewicht ,&nbsp;Olivier Hertel ,&nbsp;Karine Lacombe ,&nbsp;Corentin Lacroix ,&nbsp;Philippe Moreau-Chevrolet ,&nbsp;Sylvie Quelet ,&nbsp;Priscille Rivière ,&nbsp;Marie-Claude Lagouanelle ,&nbsp;Joëlle Micallef","doi":"10.1016/j.therap.2025.11.010","DOIUrl":"10.1016/j.therap.2025.11.010","url":null,"abstract":"<div><div>Recognising the pivotal role of health products in our society, the challenges around accessing reliable information in a fast-expanding digital environment, and the essential role played by health literacy in enabling citizens to make informed choices, this round table session was convened to identify strategies for improving health product education and understanding among the general public. Having discussed the concept of health literacy and those initiatives already in place, the participants put forward ten recommendations (R) for improving health product literacy: definition of a consensus-based common core of minimum knowledge about medicines to provide a benchmark level of public understanding (R1); development of a multimodal information campaign coordinated at national, local and individual levels (R2); implementation of long-term interventions with repeated, age-appropriate, and context-sensitive messaging (R3); early introduction of health product education early in schools via lessons and health services (R4); promotion of high-quality education by embracing psychosocial skills and co-constructing messages with public contributors (R5); proactive engagement in digital environments to ensure visibility of reliable content (R6); promotion and upscaling of existing initiatives and educational content (R7); introduction of a trusted structure that centralises validated content (R8); using prescriptions to deliver personalised information (R9); and contribution to national discussions around health-related misinformation (R10).</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 99-106"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmaco-métabolomique et métabolomique : un nouvel outil en médecine de précision ?","authors":"Antonin Lamazière ,&nbsp;Erwan Werner ,&nbsp;Caroline Barau ,&nbsp;Jean-François Benoist ,&nbsp;Hélène Blasco ,&nbsp;David Bonnel ,&nbsp;Abd El Kader Ait-Tayeb ,&nbsp;Florence Castelli ,&nbsp;Benjamin Guiot ,&nbsp;Najiba Lahlou ,&nbsp;Magali Sarafian ,&nbsp;Olivier Blin ,&nbsp;Céline Verstuyft","doi":"10.1016/j.therap.2025.12.001","DOIUrl":"10.1016/j.therap.2025.12.001","url":null,"abstract":"<div><div>La médecine de précision vise à intégrer les caractéristiques individuelles des patients dans les décisions thérapeutiques. La métabolomique et la pharmaco-métabolomique permettent d’explorer directement le phénotype biologique en analysant l’ensemble des métabolites présents dans un organisme. Ces approches offrent une vision intégrative tenant compte des interactions entre génome, environnement, microbiote et mode de vie. Elles ouvrent la voie à une meilleure prédiction de l’efficacité des traitements et à une réduction des effets indésirables. Leur mise en œuvre se heurte toutefois à des défis techniques, analytiques, organisationnels et réglementaires. Les Ateliers de Giens 2025 ont réuni des experts académiques, institutionnels et industriels afin d’identifier les ambitions de la pharmaco-métabolomique et les obstacles à son développement afin de proposer des recommandations. Ces recommandations concernent la standardisation des pratiques, la formation des professionnels, l’interopérabilité des données et l’accessibilité des outils analytiques. La pharmaco-métabolomique apparaît ainsi comme un levier majeur pour l’intégration du phénotype biologique dans la médecine personnalisée à l’horizon 2030.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 1-9"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147271980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dispositif médical à usage professionnel : quelle évaluation, quel financement ?","authors":"Valéry-Pierre Riche ,&nbsp;Laure de Place ,&nbsp;Xavier Armoiry ,&nbsp;Dorothée Camus ,&nbsp;Cécile Charle-Maachi ,&nbsp;Mikael Deslandes ,&nbsp;Christian Espagno ,&nbsp;Jerome Fabiano ,&nbsp;Line Farah ,&nbsp;Mathieu Grajoszex ,&nbsp;Erin Johns ,&nbsp;Anne Josseran ,&nbsp;Adrien Michaud ,&nbsp;Louis Potel ,&nbsp;Peggy Rematier ,&nbsp;Thomas Riquier ,&nbsp;Vincent Vercamer ,&nbsp;Lou Verrier ,&nbsp;Eric Vicaut ,&nbsp;Isabelle Durand-Zaleski","doi":"10.1016/j.therap.2025.10.007","DOIUrl":"10.1016/j.therap.2025.10.007","url":null,"abstract":"<div><div>Les dispositifs médicaux à usage professionnel (DMUP) occupent une place croissante dans les systèmes de santé, portés par l’essor des technologies numériques. Ils regroupent une large gamme d’équipements allant de la chirurgie robotisée aux solutions logicielles d’aide au diagnostic. Les DMUP ne disposent pas de définition spécifique, ce qui complexifie leur intégration dans les circuits de financement. Depuis les années 2010, deux dynamiques principales ont accéléré leur diffusion : d’une part, l’innovation technologique (robotique, intelligence artificielle, télésurveillance, objets connectés) améliorant précision, efficience et qualité des soins ; d’autre part, la pression croissante sur les systèmes de santé liée au vieillissement de la population et à la démographie médicale. En France comme en Europe, les autorités de régulation reconnaissent leur potentiel, tout en soulignant les difficultés à les intégrer dans les cadres traditionnels de remboursement. En effet, le modèle français, centré sur la LPPR, s’adapte mal aux DMUP, notamment aux équipements lourds et aux DM numériques. Ceux-ci sont financés via des dotations ou intégrés aux tarifs hospitaliers, sans réelle évaluation systématique. Le règlement européen (UE) 2017/745 a renforcé les exigences cliniques, tandis que des expérimentations comme ETAPES ont ouvert la voie à des financements innovants. Néanmoins, l’évaluation des DMUP reste entravée par la difficulté à démontrer leur valeur clinique et l’insuffisante prise en compte de leur impact organisationnel. Face à ces défis, de nouvelles approches émergent : modèles centrés sur la valeur, élargissement des critères d’évaluation aux gains organisationnels et recours accru aux données en vie réelle. Dans ce contexte, les Ateliers de Giens 2025 ont consacré une table ronde à l’évaluation et au financement des DMUP, afin de proposer des recommandations adaptées aux besoins des soins, du système de santé et des industriels.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 42-55"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145896934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment améliorer le niveau d’éducation (littératie) de la population sur les produits de santé ?","authors":"Clara Locher ,&nbsp;Nathalie Manaud ,&nbsp;Mathieu Molimard ,&nbsp;Catherine Cassé-Perrot ,&nbsp;Jean-Luc Cracowski ,&nbsp;Cyril Di Palma ,&nbsp;Luc Duchossoy ,&nbsp;Chantal Gatignol ,&nbsp;Anthony Goldgewicht ,&nbsp;Olivier Hertel ,&nbsp;Karine Lacombe ,&nbsp;Corentin Lacroix ,&nbsp;Philippe Moreau-Chevrolet ,&nbsp;Sylvie Quelet ,&nbsp;Priscille Rivière ,&nbsp;Marie-Claude Lagouanelle ,&nbsp;Joëlle Micallef","doi":"10.1016/j.therap.2025.11.011","DOIUrl":"10.1016/j.therap.2025.11.011","url":null,"abstract":"<div><div>Consciente de l’importance des produits de santé dans notre société, des difficultés d’accès à une information fiable dans un contexte numérique en pleine expansion, et du rôle essentiel de la littératie en santé pour permettre aux citoyens de faire des choix éclairés, la table ronde a été organisée afin d’identifier des leviers visant à renforcer l’éducation et la compréhension des produits de santé au sein de la population. Après avoir échangé sur la définition de la littératie en santé ainsi que sur des initiatives déjà mises en œuvre, les participants ont formulé dix recommandations (R) pour améliorer la littératie sur les produits de santé : définir un socle commun de connaissances minimales sur les médicaments, validé par consensus, pour harmoniser les bases de compréhension du public (R1) ; développer une information multimodale et coordonnée aux niveaux national, local et individuel (R2) ; inscrire les interventions sur la durée, en répétant et adaptant les messages selon l’âge et le contexte (R3) ; intervenir précocement en milieu scolaire en intégrant les produits de santé dans les enseignements et le service sanitaire (R4) ; construire une éducation de qualité en prenant en compte les compétences psychosociales et en coconstruisant les messages avec le public (R5) ; occuper activement l’espace numérique pour rendre visibles des contenus fiables (R6) ; valoriser et diffuser les initiatives et contenus existants à plus grande échelle (R7) ; mettre en place une structure de confiance centralisant les contenus validés (R8) ; intégrer les ordonnances comme support d’information personnalisée (R9) ; et contribuer à la réflexion nationale sur la lutte contre la désinformation (R10).</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 91-98"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How to differentiate between clinical added value (CAV) V drugs: What are the implications, and what is the access pathway?","authors":"Clémentine Body ,&nbsp;Frédéric Chassagnol ,&nbsp;Driss Berdaï ,&nbsp;Jean-François Bergmann ,&nbsp;Isabelle Borget ,&nbsp;Carole Doré ,&nbsp;Alexandra Durr ,&nbsp;Bruno Falissard ,&nbsp;Joumana Hudry ,&nbsp;Benjamin Kowalski ,&nbsp;Philippe Maugendre ,&nbsp;Nicolas Schlumberger ,&nbsp;Elodie Wilmet ,&nbsp;Claire Le Jeunne","doi":"10.1016/j.therap.2025.10.010","DOIUrl":"10.1016/j.therap.2025.10.010","url":null,"abstract":"<div><div>Level V clinical added value (CAV) refers to a lack of CAV improvement of a new medicine, as assessed by the French Transparency Committee, compared to a standard of care therapeutic strategy. In 2024, 56% of medicines evaluated in primary registration or extended indication (excluding simplified procedures) were assigned an CAV V, compared with 44% in 2023. Obtaining an CAV V sometimes leads to the product not being available to patients, especially in the event of non-inclusion on the costly drug list for hospital products or after failure of negotiation between the drug manufacturers and the Health Products Economic Committee. The Giens workshops wished to devote a round table to the study of these drugs and analyse the different situations leading to CAV V to make proposals allowing access for patients to these drugs that are the subject of very specific CAV V situations.</div><div>Three situations could benefit from specific attention: (i) Medicinal products for which the submitted clinical data does not allow the French Health Authority (HAS), at the time of evaluation, to decide on the quantity of clinical effect; (ii) Drugs for which the clinical effect is low or for which clinical relevance is discussed; (iii) Drugs for which no added clinical benefit is demonstrated but for which non-clinical benefits (such as organisational impact on care, or long-term savings) are identifiable.</div><div>Following the analysis of these different situations and using examples, the members of the round table made eight concrete proposals to allow patients to access these products, in certain blocking situations.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 117-126"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145900871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Développer, organiser et valoriser les structures d’évaluation des technologies de santé hospitalières en France","authors":"Nicolas Martelli ,&nbsp;Christophe Roussel ,&nbsp;Anne Grumblat ,&nbsp;Philippe Lechat ,&nbsp;Romain Aubourg ,&nbsp;Pauline Beaumel ,&nbsp;Norman Bodet ,&nbsp;Albane Degrassat-Théas ,&nbsp;Fanette Denies ,&nbsp;Pascale Guerre ,&nbsp;Fatima Heniche ,&nbsp;Aurélie Lavorel ,&nbsp;Isabelle Maachi ,&nbsp;Tess Martin ,&nbsp;Benoît Salaün","doi":"10.1016/j.therap.2025.10.009","DOIUrl":"10.1016/j.therap.2025.10.009","url":null,"abstract":"<div><div>L’évaluation des technologies de santé (ETS) éclaire les décisions publiques en matière de prise en charge des innovations médicales. En France, la Haute autorité de santé (HAS) en est l’acteur central. À l’hôpital, une forme spécifique d’ETS–l’ETS hospitalière (ETS-H)–s’est développée pour évaluer les technologies dans leur contexte local, contribuant à une meilleure allocation des ressources et à une gestion raisonnée de l’innovation. Toutefois, l’ETS-H reste peu développée en France. Dans ce contexte, la table ronde n^o 4 des Ateliers de Giens, rassemblant des experts issus du monde académique, hospitalier, institutionnel et industriel, s’est penchée sur les freins et les solutions qui permettraient de développer, d’organiser et de valoriser les structures d’ETS-H en France. La table ronde a permis d’identifier plusieurs constats majeurs freinant le développement de l’ETS-H. Tout d’abord, le périmètre d’application de l’ETS-H reste limité, de même que le nombre de ses bénéficiaires potentiels. Ensuite, cette activité souffre d’un manque de reconnaissance institutionnelle et stratégique. À cela s’ajoutent une insuffisance marquée en ressources humaines, organisationnelles et financières, ainsi qu’une diffusion trop restreinte des résultats produits, tant en interne qu’en externe. Enfin, l’absence d’harmonisation des méthodes d’évaluation nuit à la lisibilité et à l’impact de ces démarches. Pour répondre à ces enjeux, la table ronde a formulé cinq recommandations structurantes : (1) étendre les usages de l’ETS-H dans l’ensemble du système de santé ; (2) valoriser son utilité afin d’en renforcer la reconnaissance ; (3) financer des centres pilotes et instaurer un financement pérenne ; (4) organiser le partage des évaluations réalisées ; et (5) promouvoir une méthodologie commune et soutenir la formation des acteurs concernés.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"81 1","pages":"Pages 70-80"},"PeriodicalIF":1.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145896895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}