The European “Clinical Trial” Regulation; Relationship with the Jardé Act: a Giens Workshop

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency. Abbreviations: see end of article

Le règlement européen «essais cliniques» : articulation avec la loi Jardé : un atelier de Giens

Le Parlement et le Conseil de l’Union Européenne ont publié en mai 2014 un nouveau règlement relatif aux essais cliniques de médicaments, destiné à remplacer la directive 2001/20/CE. Sa mise en application n’interviendra pas avant 2016. Néanmoins, il est essentiel de se préoccuper dès à présent de l’articulation de ce texte avec la législation nationale, c’est-à-dire de la loi Jardé dont la mise en œuvre a été retardée, précisément dans l’attente de la publication du règlement européen. L’atelier de Giens a listé et étudié les différents problèmes que cette articulation ne manquera pas de poser. Ont été particulièrement abordés : les modalités d’évaluation de la méthodologie des essais, l’articulation fonctionnelle entre l’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) et les Comités de Protection des Personnes (CPP) pendant cette phase d’évaluation des demandes d’autorisation, l’évaluation des études post-autorisation/inscription des médicaments et des dispositions médicaux, la transparence des données. Abréviations : voir en fin d’article

The European “Clinical Trial” Regulation: Relationship with the Jardé Act: a Giens Workshop

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency. Abbreviations: see end of article

[Swallowing disorders, pneumonia and respiratory tract infectious disease in the elderly] : Troubles de la déglutition du sujet âgé et pneumopathies en 14 questions/réponses

International audienceSwallowing disorders (or dysphagia) are common in the elderly and their prevalence is often underestimated. They may result in serious complications including dehydration, malnutrition, airway obstruction, aspiration pneumonia (infectious process) or pneumonitis (chemical injury caused by the inhalation of sterile gastric contents). Moreover the repercussions of dysphagia are not only physical but also emotional and social, leading to depression, altered quality of life, and social isolation. While some changes in swallowing may be a natural result of aging, dysphagia in the elderly is mainly due to central nervous system diseases such as stroke, parkinsonism, dementia, medications, local oral and oesophageal factors. To be effective, management requires a multidisciplinary team approach and a careful assessment of the patient's oropharyngeal anatomy and physiology, medical and nutritional status, cognition, language and behaviour. Clinical evaluation can be completed by a videofluoroscopic study which enables observation of bolus movement and movements of the oral cavity, pharynx and larynx throughout the swallow. The treatment depends on the underlying cause, extent of dysphagia and prognosis. Various categories of treatment are available, including compensatory strategies (postural changes and dietary modification), direct or indirect therapy techniques (swallow manoeuvres, medication and surgical procedures)