Therapie最新文献

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called “patient centricity in pharmacovigilance”. Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.

Les essais cliniques durent souvent plusieurs mois voire plusieurs années. Au fur et à mesure de l’avancée de l’essai, il peut être tentant de s’assurer que les données accumulées ne permettent pas déjà de répondre à la question posée par l’essai et ainsi arrêter précocement les inclusions ou le suivi. Mais de façon contre-productive, la connaissance et la prise en compte de résultats intermédiaires peuvent, dans certaines conditions, compromettre l’intégrité des résultats. C’est pour limiter ce risque – et assurer ainsi une fiable évaluation des thérapeutiques – que cette surveillance de critères de sécurité et|ou d’efficacité en cours d’étude est confiée à un comité de surveillance indépendant. À partir des résultats qui leur sont transmis de façon confidentielle, le comité de surveillance indépendant évalue la balance bénéfice-risque du traitement à l’étude et établit une recommandation quant à la poursuite, la modification ou l’arrêt de l’étude. Au travers de ces recommandations, les membres des comités de surveillance indépendants ont une responsabilité importante : une décision d’arrêt trop hâtive peut rendre l’essai non concluant et infructueux pour répondre à la question initiale et au contraire, une décision d’arrêt trop tardive peut exposer les participants à des interventions potentiellement inefficaces voire nocives. La mission confiée aux membres des comités de surveillance indépendants est donc particulièrement complexe. Dans ce contexte, la table ronde des ateliers de Giens a été l’occasion de revenir sur la justification scientifique vis-à-vis de l’organisation des comités de surveillance indépendants et de rappeler la nécessite pour les membres des comités de surveillance indépendants d’être parfaitement formés aux problématiques inerrantes aux analyses multiples, à l’obligation de confidentialité vis-à-vis des résultats et au fait que les recommandations d’arrêt doivent reposer sur des données suffisamment convaincantes pour évaluer la balance bénéfice-risque du traitement étudié.

La place croissance du numérique, des réseaux sociaux, la multiplicité des canaux et la volumétrie des informations, la place du médicament désormais objet sociétal, ainsi qu’une parole publique insuffisante et peu adaptée aux situations d’incertitude sont autant de constats ayant motivé le thème de cette table ronde. Apres avoir échangé autour de la définition de la désinformation qui ne se limite pas aux fake news, et autour des contributeurs intentionnels ou non de la désinformation, les participants de cette table ronde ont émis neuf recommandations (R) pour lutter contre la désinformation sur les produits de santé : la création d’une plateforme collaborative « information/formation sur les produits de santé », plateforme avec 5 qualités majeures : accessibilité, flexibilité, objectivités, transparence et indépendance et avec des supports adaptés aux différentes cibles (R1) ; promouvoir les connaissances de base sur les produits de santé : éducation/formation afin de restaurer l’image particulièrement dégradée du médicament et de former le public à utiliser de manière appropriée des notions de base (R2) ; renforcer la parole publique partant du constat que l’information est la principale arme contre la désinformation ; la coordination de la communication des différentes institutions doit rendre plus audible la parole publique, clarifier les messages institutionnels, les rendre les plus factuels et les hiérarchiser (R3) ; savoir communiquer avec les bons codes et outils (R4) ; développer la recherche sur la communication dans le domaine des produits de santé (R5) ; se doter d’outils d’identification précoce et de régulation (R6) ; maîtriser les contenus en développant l’esprit critique (R7) ; définir les critères de qualité des sources d’information (R8) ; identifier, évaluer et référencer les initiatives pour le public qui pourraient être implémentées sur la plateforme (R9)

Healthcare product procurement accounts for around 50% of the French healthcare system's greenhouse gas emissions. This lesson learned from the publication of the Shift Project's work in November 2021 has been a catalyst within the healthcare system, accelerating the consideration and implementation of actions aimed at reducing the environmental impact of the healthcare system, before, during and after care. In addition to their carbon footprint, healthcare products have a wide range of environmental impacts, including on water, air and soil, throughout their entire life cycle. We have chosen to divide this life cycle into four main stages: from research and development to production, distribution and market access, use and finally end-of-life management. Analysis of the regulatory framework at each stage and of existing initiatives described in the literature or by those in the field have structured and fuelled our thinking. We found that existing regulations focus exclusively on the health risk, with little or no consideration of the environmental risk, which is in itself a health risk. Furthermore, the implementation of certain structuring actions during the first 3 stages of the life cycle would make it possible to simplify or even eliminate the major problem of waste management associated with the end-of-life of healthcare products. With this in mind, we have produced 9 recommendations to ensure that the environmental impact of healthcare products is better taken into account throughout their life cycle.

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability. In France and Europe, the construction of evidence, the assessment process and evaluation methodologies with a view to purchase or reimbursement must adjust to these changes, given the specific features of these technologies. This digital leap has opened up new perspectives for healthcare, along with economic, ethical and regulatory issues. The challenge is to assess the clinical and organisational impact, reliability, safety, interoperability, efficiency and budgetary impact of DMDs in line with the requirements of new standards, guidelines and regulations. This should result in a coherent, pragmatic and proportionate evaluation, so that public decision-makers and buyers can take advantage of the potential opportunities that these digital devices offer to improve healthcare delivery. Thus, a fair and informed evaluation of DMDs would emerge, providing a solid basis to steer their inclusion into contemporary medical practices. This fundamental issue of evaluation, linked to the digital nature of these MDs, is what the round table, comprising experts from academia and/or hospitals, institutions and industry, sought to resolve. Discussions led to proposals on how DMDs should be evaluated, bearing in mind their complexity. The round table set out to identify the bottlenecks in the entire evaluation process, from the CE marking phase, compliance with French safety and interoperability requirements, through to national or local evaluation, in order to inform a purchasing policy and draw up proposals covering the entire spectrum. Ten concrete recommendations were put forward by the round table, aimed at improving the evaluation process by making it clearer and more adaptable, thus offering greater flexibility in the evaluation and decision-making stages. This well-thought-out approach is designed to facilitate a comprehensive and flexible evaluation of DMDs given the constantly evolving technological context.

Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity of the results, which is counterproductive. To minimise this risk and ensure that the treatments are assessed reliably, safety and/or efficacy criteria are monitored during the study by a Data Monitoring Committee. After receiving the results confidentially, the Data Monitoring Committee assesses the benefit/risk ratio of the study treatment and recommends that the trial be continued, modified or terminated. Data Monitoring Committee members issuing these recommendations have an important responsibility: a hasty decision to end the trial may lead to inconclusive results unable to answer the initial question and, inversely, delaying the decision to end the trial may expose the subjects to potentially ineffective or even harmful interventions. The Data Monitoring Committee's task is therefore particularly complex. With this in mind, the round table discussion at the Giens workshops was a chance to review the scientific justification for creating Data Monitoring Committees and to recall the need for their members to receive comprehensive training on the complexities of multiple analyses, confidentiality requirements applying to the results and the need for them to be aware that recommendations to end a trial must be based on data that is robust enough to assess the benefit/risk ratio of the treatment studied.