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Ces dernières années, la prise en charge de la maladie thromboembolique veineuse (MTEV), incluant les thromboses veineuses profondes (TVP) et les embolies pulmonaires (EP), tend à se modifier. Une possibilité de prise en charge ambulatoire, exclusive ou après un court séjour hospitalier (moins de 24 h), est ainsi proposée par certaines sociétés savantes, principalement les EP à faible risque (simplified pulmonary embolism severity index = 0) et certaines EP à risque intermédiaire, pour certains patients (sujet jeune, sans comorbidité, ayant compris la maladie et le traitement anticoagulant, et non socialement isolés). C'est dans ce contexte qu'un groupe de travail pluridisciplinaire, regroupant des médecins de diverses spécialités, exerçant à l'hôpital ou en ville et impliqués dans la MTEV, a été créé dans notre région (Alsace) avec pour objectif de travailler sur le parcours de soin de la MTEV, surtout sur la prise en charge ambulatoire, et de proposer des recommandations pour les médecins exerçant en ville. Ces dernières font apparaître que la prise en charge de la MTEV, outre qu'elle doit cibler un phénotype bien précis de patients, doit reposer, en cas de prise en charge ambulatoire et en ville, un parcours de soins organisé, structuré et coordonné (« optimisée » ou « optimale »). [ABSTRACT FROM AUTHOR]

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La Covid-19, due au virus Sars-CoV-2, semble prédisposer les patients aux phénomènes thrombotiques (artériels et veineux). Ces atteintes apparaissent liées à l'inflammation excessive ainsi qu'à une dysfonction plaquettaire et endothéliale. [ABSTRACT FROM AUTHOR]

Seizures are very common in the Emergency Department (ED). We present here a case of a young woman with neurocysticercosis ; a worldwide and nearly endemic cause of seizure in the southern hemisphere. Clinical manifestations are very different between patients from asymptomatic to life-threatening hydrocephalus. Diagnosis is based on a combination of clinical presentation, neuroimaging (CT and MRI) findings, history of exposure, and serologic testing., Competing Interests: Les auteurs n’ont déclaré aucun conflit d’intérêts en relation avec cet article.

Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector., (© 2015 Société Française de Pharmacologie et de Thérapeutique.)

Clinical research is of major importance to today's society, as scientific evidence is increasingly demanded as a basis for progress, whether this involves developing new healthcare products, improving clinical practice and care protocols or progress in prevention. Clinical research therefore requires professionals who are both experienced and increasingly well trained. Against this background, allied health professionals are becoming involved more and more, both as team members supporting clinical research projects and as managers or coordinators of projects in their own field. Clinical research activities provide an ideal opportunity for continuing professional development. All of this means that the professional skills of the allied health professions and clinical research support professions must be enhanced, their role promoted in the context of lecturer status and in the longer term, their status recognised by the supervisory authorities., (© 2014 Société Française de Pharmacologie et de Thérapeutique.)

In pharmacoepidemiology studies, the nature of the research question will dictate the choice of methodological approach and the conditions for optimizing the level of evidence. Thus, to document the treated population and the modes of use of a new drug in real-life prescribing conditions, a descriptive approach through cross-sectional or longitudinal studies conducted on databases, or else ad-hoc studies, will be preferred. On the other hand, evaluation of the real-life "effectiveness" of a new drug will be based on cohort, case-control or scientific modeling, depending on the drug and the disease of interest. For questions involving drug risks and safety, it is the adverse effects profile that will guide the choice of study design, both for identification of the effect (signal) and assessment of causation. In all cases, in the post-marketing authorization (MA) setting, the evidence acquired in pre-MA studies serves as the basis for generating hypotheses. Whatever the research question and the method chosen to address it, the potential biases and their impact on the results need to be identified. In certain cases, a combination of several complementary approaches may prove preferable to a single study., (© 2013 Société Française de Pharmacologie et de Thérapeutique.)

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive's dispositions could be improved, such as the definition of "investigational medicinal products" (IMP) and what should be considered as "substantial amendements", as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states. Other points in the Directive do require revision, especially those relating to: the definition of the respective roles of Ethics Committees and Competent Authorities, the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report), the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational. The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country's regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as "drug therapy strategy trials", modulating restrictions according to the "risk added by the research" would enable the trial's organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling., (© 2010 Société Française de Pharmacologie et de Thérapeutique.)