Therapie最新文献

{"title":"Éthique et recherche clinique : quelles évolutions pour les CPP et les comités d’éthique de la recherche ?","authors":"Driss Berdaï ,&nbsp;Aurélie Guérin ,&nbsp;David Pérol ,&nbsp;Cécile Girault ,&nbsp;Mathieu Molimard ,&nbsp;Philippe Amiel ,&nbsp;Hélène Beaussier ,&nbsp;Pierre-Henri Bertoye ,&nbsp;Catherine Cornu ,&nbsp;Dominique Deplanque ,&nbsp;Didier Dreyfuss ,&nbsp;Luc Duchossoy ,&nbsp;Cécile Fouret ,&nbsp;Thibaud Haaser ,&nbsp;Anne Le Louarn ,&nbsp;Soraya Rifai ,&nbsp;Jean-Pierre Thierry","doi":"10.1016/j.therap.2024.10.051","DOIUrl":"10.1016/j.therap.2024.10.051","url":null,"abstract":"<div><div>Conformément à l’esprit des Ateliers de Giens, cet article rapporte les évolutions souhaitables du fonctionnement des Comités de protection des personnes (CPP) et des Comités d’éthique de la recherche (CER) en France. Ces comités jouent un rôle crucial dans l’évaluation éthique des projets de recherche clinique, un processus devenu plus complexe compte-tenu en particulier des évolutions récentes législatives, réglementaires et méthodologiques. Le résultat de cette réflexion met en lumière les défis actuels auxquels les CPP font face, notamment la charge croissante de travail, la complexité des dossiers à traiter et le besoin d’un meilleur usage de leurs ressources. Pour y répondre, plusieurs recommandations sont proposées. Parmi celles-ci figurent l’amélioration de l’accompagnement des promoteurs avant la soumission des dossiers, la simplification des tâches administratives pour les membres des CPP et l’amélioration des outils informatiques. L’article souligne également le besoin d’évaluation continue des activités des CPP pour contribuer à la qualité et la cohérence de leurs avis, ainsi que l’importance de rendre cette activité plus attractive pour les professionnels qualifiés, en leur proposant des indemnisations et une reconnaissance professionnelle adéquates. Pour le bénéfice de l’ensemble des acteurs de la recherche en santé, il est fortement souhaité le développement d’une base documentaire unique accessible à tous et regroupant toutes les informations et modèles de documents utiles. Concernant les CER, qui agissent actuellement sans cadre juridique, il est en particulier proposé que leur développement se fasse dans des conditions de conformité à des principes essentiels de collégialité, de transparence et de gestion appropriée des liens d’intérêts. Enfin, il est apparu nécessaire que la Commission nationale des recherches impliquant la personne humaine (CNRIPH) bénéficie de ressources appropriées pour remplir efficacement ses missions incluant la coordination des CPP et l’élaboration de programmes de formation adaptés pour leurs membres. Ces recommandations visent à améliorer les conditions de fonctionnement des CPP et CER, assurant l’éthique des recherches engagées, ainsi que la qualité des résultats de ces dernières.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 135-144"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628704","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":"Attentes méthodologiques pour la démonstration de l’efficacité des produits de santé par les études observationnelles","authors":"Michel Cucherat ,&nbsp;Olivier Demarcq ,&nbsp;Olivier Chassany ,&nbsp;Claire Le Jeunne ,&nbsp;Isabelle Borget ,&nbsp;Cécile Collignon ,&nbsp;Vincent Diebolt ,&nbsp;Marion Feuilly ,&nbsp;Béatrice Fiquet ,&nbsp;Clémence Leyrat ,&nbsp;Florian Naudet ,&nbsp;Raphaël Porcher ,&nbsp;Nathalie Schmidely ,&nbsp;Tabassome Simon ,&nbsp;Matthieu Roustit","doi":"10.1016/j.therap.2024.10.052","DOIUrl":"10.1016/j.therap.2024.10.052","url":null,"abstract":"<div><div>La problématique de l’évaluation de l’efficacité des technologies de santé (médicaments, dispositifs, etc.) par les études observationnelles prend de plus en plus d’importance depuis que les agences d’enregistrement et d’accès au marché envisagent de les considérer dans leur processus d’évaluation. Dans ce contexte, les études observationnelles doivent être capables d’apporter de réelles démonstrations, d’un niveau de fiabilité comparable à celles produites par l’approche classique basée sur l’essai randomisé et contrôlé (RCT). L’objectif de la table ronde a été d’établir les critères d’acceptabilité pour qu’une étude observationnelle (« <em>non-randomized</em>, <em>non-interventional study</em> ») puisse prétendre apporter ces démonstrations, et éventuellement servir d’étude confirmatoire pour les autorités d’enregistrement et d’accès au marché, la construction des stratégies thérapeutiques ou l’élaboration des recommandations. Pour cela, l’étude doit être une véritable étude de confirmation respectant la démarche hypothético-déductive et garantissant l’absence de HARKing et de p-hacking en attestant de l’élaboration d’un protocole et d’un plan d’analyse statistique, enregistrés avant toute analyse inférentielle. Elle doit aussi s’inscrire dans une démarche formalisée d’inférence causale et montrer qu’elle permet d’identifier correctement l’estimand causal recherché. L’étude doit garantir l’absence de biais de confusion résiduelle à l’aide d’une prise en compte de tous les facteurs de confusion affectant la comparaison, ceux-ci devant être déterminés par une approche formelle (de type graphique de causalité, DAGs). Les diagnostics de biais de confusion résiduel par analyse de falsification et de nullification doivent montrer leur absence. L’étude doit être à faible risque de biais, en particulier de biais de sélection, entre autres en utilisant un design d’émulation d’essai cible. Le risque alpha global doit être strictement contrôlé. L’absence de publication sélective de résultat et de biais de sélection doit être garantie.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 33-46"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment faciliter la diffusion des tests de pharmacogénétique ?","authors":"Céline Verstuyft ,&nbsp;Dominique Dewolf ,&nbsp;Olivier Blin ,&nbsp;Virginie Florentin ,&nbsp;Laurent Mesnard ,&nbsp;Boris Chaumette ,&nbsp;Estelle Ayme-Dietrich ,&nbsp;Laure Raymond ,&nbsp;Marie Lang ,&nbsp;Antonin Lamazière ,&nbsp;Béatrice Allard ,&nbsp;Laurence Samelson ,&nbsp;Liliane Lamezec ,&nbsp;Marie-Anne Loriot ,&nbsp;Antoine Le Bozec ,&nbsp;Nicolas Picard","doi":"10.1016/j.therap.2024.11.007","DOIUrl":"10.1016/j.therap.2024.11.007","url":null,"abstract":"<div><div>La médecine des 4 P (personnalisée, préventive, prédictive, participative) connaît un essor remarquable, et la pharmacogénétique en est un élément incontournable. Cependant, plusieurs obstacles freinent son déploiement. Cette table ronde a réuni un groupe d’experts qui ont dressé un état des lieux, tout en réfléchissant aux moyens de faciliter la prescription de ces tests et la diffusion des résultats à l’échelle nationale. Les experts se sont penchés sur les modalités de prescription et de communication des données de pharmacogénétique dans le contexte actuel, mais aussi dans les prochaines années avec l’arrivée de logiciels d’intelligence artificielle. Les questions relatives au remboursement des tests, toujours d’actualité, ont également été discutées, car il s’agit d’un levier pour permettre à tous les patients d’accéder à ces tests. De nombreuses recommandations ont été formulées sur ces différents points, visant à faciliter la maîtrise de la prescription par les professionnels de santé, tout en garantissant la conservation et l’utilisation des résultats tout au long de la vie du patient. Enfin, il a été recommandé de mieux informer les patients et de renforcer l’implication des professionnels de santé ainsi que des industriels dans cette démarche, en insistant sur la formation et l’engagement nécessaires pour assurer son succès.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 93-102"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877901","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":"Données de santé : l’accès régionalisé est un défi prioritaire pour construire un patrimoine national des données de santé sécurisé, transparent et innovant","authors":"Daniel Szeftel ,&nbsp;Vianney Jouhet ,&nbsp;Gilles Duluc ,&nbsp;Cécile Charle-Maachi ,&nbsp;Thomas Sejourné ,&nbsp;Jérôme Fabiano ,&nbsp;Hélène Guimiot ,&nbsp;Aurore Gaignon ,&nbsp;Caroline Germain ,&nbsp;Quentin Demanet ,&nbsp;Emmanuel Merieux ,&nbsp;Thomas Rapp","doi":"10.1016/j.therap.2024.12.007","DOIUrl":"10.1016/j.therap.2024.12.007","url":null,"abstract":"<div><div>La France est engagée dans une transition juridique et organisationnelle depuis de nombreuses années. Elle doit adapter son cadre national avec les nécessités juridiques de protection des données personnelles, avec les ambitions européennes et la concurrence internationale. Depuis la loi Informatique et Libertés de 1978 et jusqu’à la loi de 2019 sur la transformation du système de santé, les réformes ont renforcé les exigences en matière de protection des données personnelles, tout en ouvrant la voie à des usages innovants. Les récents règlements européens, comme l’AI Act (2024) et l’Espace européen des données de santé (2024), visent à renforcer cette dynamique, en assurant un cadre sécurisé, transparent et compétitif pour le partage et l’utilisation des données de santé. Comment garantir une véritable efficacité dans la réutilisation des données issues du soin tout en respectant les droits fondamentaux des citoyens ? Comment concilier des ambitions nationales et européennes avec les réalités techniques et organisationnelles du système de santé, dans les équipes cliniques et de recherche, et au plus près des patients et des usagers dans nos territoires ? Ces questions sont essentielles car l’accès et l’usage des données de santé sont perçus comme des leviers majeurs pour améliorer la qualité des soins, soutenir l’innovation et renforcer la compétitivité du système de santé français. L’étude d’impact de la réforme de 2019 souligne que la transformation du système de santé devra reposer sur une meilleure prise en compte des besoins des patients et des professionnels, en favorisant les initiatives territoriales. Dans ce contexte, la France fait face à une priorité : instaurer une coordination renforcée entre les niveaux national et local, tout en préservant la confiance des usagers. Cette confiance si précieuse doit permettre d’assurer cette transition pour atteindre les objectifs nationaux et européens en matière de valorisation scientifique et économique des données.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 113-123"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012198","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":"Ethics and clinical research: How can the Ethics Committees (CPPs) and Committees for Research Ethics (CER) evolve?","authors":"Driss Berdaï ,&nbsp;Aurélie Guérin ,&nbsp;David Pérol ,&nbsp;Cécile Girault ,&nbsp;Mathieu Molimard ,&nbsp;Philippe Amiel ,&nbsp;Hélène Beaussier ,&nbsp;Pierre-Henri Bertoye ,&nbsp;Catherine Cornu ,&nbsp;Dominique Deplanque ,&nbsp;Didier Dreyfuss ,&nbsp;Luc Duchossoy ,&nbsp;Cécile Fouret ,&nbsp;Thibaud Haaser ,&nbsp;Anne Le Louarn ,&nbsp;Soraya Rifai ,&nbsp;Jean-Pierre Thierry","doi":"10.1016/j.therap.2024.11.006","DOIUrl":"10.1016/j.therap.2024.11.006","url":null,"abstract":"<div><div>In line with the spirit of the Giens workshops, this article reports on the recommended evolution of the Ethics Committees (CPPs) and the Committees for Research Ethics (CER) in France. These committees play a crucial role in the ethical evaluation of clinical research projects, a process that has become more complex, particularly in view of recent legislative, regulatory and methodological developments. This reflection highlights the current challenges faced by the CPPs, including the increasing workload, the complexity of the issues to be addressed and the need for better use of their resources. To address this, several recommendations are proposed. These include improving support to sponsors prior to submission, simplifying administrative tasks for CPP members and improving IT tools. The article also highlights the need for continuous evaluation of the activities of the CPPs to contribute to the quality and consistency of their opinions, as well as the importance of making this activity more attractive to qualified professionals, by offering them adequate compensation and professional recognition. For the benefit of all involved in health research, there is a strong desire to develop a single document management system accessible to all and inclusive of relevant information and document templates. Regarding the CERs, which currently operate without a legal framework, the proposition is that their development should take place under conditions of compliance with essential principles of collegiality, transparency and appropriate management of conflict of interest. Finally, it appeared necessary that the National Commission for Research Involving the Human Person (CNRIPH) be given adequate resources to carry out its tasks effectively, including the coordination of the CPPs and the development of appropriate training programs for their members. These recommendations aim to improve the operating conditions of the CPPs and CERs, ensuring the ethics of the research undertaken, as well as the quality of their results.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 145-154"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877902","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 reform of the activity-based payment system (T2A) help in financing innovative health products?","authors":"Xavier Armoiry ,&nbsp;Nejma Saidani ,&nbsp;Martine Aoustin ,&nbsp;Dorothée Camus ,&nbsp;Auriane Cano-Chancel ,&nbsp;Sophie Carlier ,&nbsp;Albane Degrassat-Théas ,&nbsp;Anne-Aurélie Epis de Fleurian ,&nbsp;Anne Grumblat ,&nbsp;Aurélie Lavorel ,&nbsp;Mégane Lesaignoux ,&nbsp;Tess Martin ,&nbsp;Adrien Michaud ,&nbsp;Jonathan Morizot ,&nbsp;Nathalie Préaubert ,&nbsp;Valery-Pierre Riche ,&nbsp;Isabelle Durand Zaleski","doi":"10.1016/j.therap.2024.10.063","DOIUrl":"10.1016/j.therap.2024.10.063","url":null,"abstract":"<div><div>In France, the short-stay activities of public and private sector healthcare facilities have been financed since 2004 by activity-based pricing (T2A). The principle is to allow for payment determined primarily by the nature and volume of activities. T2A has enabled a major transformation compared to the old financing system, chiefly for public sector facilities that used to operate under a general allocation, and convergence between payment methods in the public and private sectors. However, official reports and public pronouncements by many hospital healthcare stakeholders have also highlighted the limits of this method of financing, leading to several reform projects. With that in mind, round table 3 of the Giens Workshops, including experts from academia and/or hospitals, institutions, and industry, questioned the impact of the new T2A reforms on access to innovative health care products in hospitals. After scoping out the issue and drawing up observations, the round table proposed six general recommendations that would be avenues for improving access to innovative health care products for hospital service users.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 77-92"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health data: Regionalised access is a priority challenge for building a secure, transparent and innovative national health data repository","authors":"Daniel Szeftel ,&nbsp;Vianney Jouhet ,&nbsp;Gilles Duluc ,&nbsp;Cécile Charle-Maachi ,&nbsp;Thomas Sejourné ,&nbsp;Jérôme Fabiano ,&nbsp;Hélène Guimiot ,&nbsp;Aurore Gaignon ,&nbsp;Caroline Germain ,&nbsp;Quentin Demanet ,&nbsp;Emmanuel Merieux ,&nbsp;Thomas Rapp","doi":"10.1016/j.therap.2024.12.008","DOIUrl":"10.1016/j.therap.2024.12.008","url":null,"abstract":"<div><div>France has been engaged in a legal and organisational transition for many years. It has had to adapt its national framework to the legal requirements of personal data protection, European ambitions and international competition. From the Data Protection Act of 1978 to the Healthcare System Transformation Act of 2019, reforms have strengthened requirements in terms of personal data protection, while opening the way to innovative uses. Recent European regulations, such as the AI Act (2024) and the European Health Data Area (2024), aim to reinforce this dynamic, ensuring a secure, transparent and competitive framework for the sharing and use of health data. How can we ensure that the re-use of healthcare data is truly effective, while respecting the fundamental rights of citizens? How can we reconcile national and European ambitions with the technical and organisational realities of the healthcare system, in clinical and research teams, and as close as possible to patients and users in our territories? These questions are essential, because access to and use of health data are seen as major levers for improving the quality of care, supporting innovation and boosting the competitiveness of the French healthcare system. The impact study on the 2019 reform stresses that the transformation of the healthcare system will have to be based on taking better account of the needs of patients and professionals by encouraging local initiatives. In this context, France faces a priority to establish greater coordination between the national and local levels, while preserving the trust of users. This precious trust is essential if we are to make the transition to achieving national and European objectives for the scientific and economic use of data.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 1","pages":"Pages 125-134"},"PeriodicalIF":2.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012199","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":"Lactic acidosis with metformin accumulation in the intensive care units of the Nord Pas de Calais region: A known serious adverse event that can be better prevented.","authors":"Sophie Gautier, Julie Truong-Minh, Johana Béné, Johanna Temime, Maxime Granier, Benjamin Hennart, Sandrine Bergeron, Emmanuelle Jaillette","doi":"10.1016/j.therap.2024.12.009","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.009","url":null,"abstract":"<p><strong>Objective: </strong>Metformin-associated lactic acidosis (MALA) is a rare but serious adverse drug reaction (ADR). The aim of the study was to identify clinical situations associated with the onset of MALA in patients hospitalised in the Nord Pas de Calais regional intensive care units (ICUs), and to assess its preventability.</p><p><strong>Material and methods: </strong>We included all cases of MALA, identified by metformin accumulation >2.3mg/dL and lactate >2.2mmol/L, reported by the regional ICU physicians to the Regional Centre of Pharmacovigilance and registered in the French Pharmacovigilance Database between 1 January 2017 and 30 December 2018.</p><p><strong>Results: </strong>One hundred and ninety-eight (198) cases of MALA were included. 38 patients died in direct association with MALA (19.2%). There was a correlation between metformin plasma accumulation and acute renal failure and with the severity of MALA (P<0.0001). All patients presented an acute intercurrent event favouring MALA, dehydration for 87 (43.9%) patients, severe infection for 65 (32.8%) patients. For 172 patients (86.7%), the prescription was not adapted to the intercurrent medical situation as recommended. Seventy (40.5%) patients consulted their general practitioner for the acute intercurrent event, 1 temporarily stopped metformin and 34.3% had been referred directly to hospital. The remaining 65.7% presented to the hospital around 4 days later due to worsening symptoms. MALA was identified as preventable in 160 patients (80.8%).</p><p><strong>Conclusions: </strong>MALA in ICUs often follow acute dehydration or infection, and these high-risk situations must be signals to prevent this serious ADR. Specific education programmes for physicians and patients could also reduce this risk.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972202","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":"Adalimumab-induced myoclonus: A potential adverse drug reaction?","authors":"Yasmine Salem Mahjoubi, Israa Dahmani, Fatma Zgolli, Widd Kaabi, Sarrah Kastalli, Imen Aouintin, Sihem El Aidli","doi":"10.1016/j.therap.2024.12.006","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.006","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932453","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":"Shaping the future of pharmacoepidemiology in France: Recommendations from the SFPT Pharmacoepidemiology Working Group.","authors":"Thomas Soeiro, Marion Allouchery, Johana Bene, Julien Bezin, Charles Dolladille, Jean-Luc Faillie, Lamiae Grimaldi, Florentia Kaguelidou, Charles Khouri, Margaux Lafaurie, Bérenger Largeau, François Montastruc, Lucas Morin, Lucie-Marie Scailteux, Antoine Pariente","doi":"10.1016/j.therap.2024.12.005","DOIUrl":"https://doi.org/10.1016/j.therap.2024.12.005","url":null,"abstract":"<p><p>The drug authorization process is shifting towards a policy aimed at shortening time-to-market. While this policy facilitates early access to new treatments, it can also result in potentially insufficient knowledge of both efficacy and safety at the time of marketing. The latter is particularly true for long-term outcomes or in specific populations (e.g., children and the elderly). Yet, French pharmacoepidemiology is currently not designed to address these challenges, despite recognized expertise. In this context, we aim: (i) to define a strategy for strengthening pharmacoepidemiology in France; and (ii) to identify the associated human, technical, and financial requirements to ensure its success. In this paper, we present the French Pharmacoepidemiology Initiative (https://frenchpharmacoepi.org/), i.e. a network of independent academic teams to complement existing institutions. It will provide coordinated expertise and a workforce to meet national and regional needs for pharmacoepidemiological monitoring and drug-related decision-making. Leveraging the existing expertise of university hospital pharmacoepidemiology units would enable rapid operational deployment to inform the decisions and policies of national regulatory agencies.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873004","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}