RESUMEN
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.
Asunto(s)
Ensayos Clínicos como Asunto/legislación & jurisprudencia , Acceso a la Información/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Seguridad Computacional/legislación & jurisprudencia , Comités de Ética Clínica/legislación & jurisprudencia , Comités de Ética Clínica/organización & administración , Comités de Ética Clínica/normas , Comités de Ética en Investigación/legislación & jurisprudencia , Comités de Ética en Investigación/organización & administración , Comités de Ética en Investigación/normas , Unión Europea , Francia , Agencias Gubernamentales , Experimentación Humana/legislación & jurisprudencia , Humanos , Lenguaje , Legislación de Dispositivos Médicos , Estudios Observacionales como Asunto/legislación & jurisprudencia , Proyectos de Investigación/normasRESUMEN
OBJECTIVE: Cyamemazine is an original phenothiazine derivative which showed similar efficacy and tolerability to lorazepam during ethanol withdrawal in mice. This study investigated cyamemazine for its efficacy and tolerability in alcohol-dependent patients electing an alcohol withdrawal procedure, in comparison with diazepam. METHOD: A multicenter, randomized, double-blind study in 89 alcohol-dependent patients (CIWA-Ar score between 10 and 30), electing an alcohol withdrawal procedure, was used to find effective doses of cyamemazine and to compare it with diazepam for efficacy and tolerability. On day 1 (D(1)), cyamemazine or diazepam (50 mg and 10 mg capsule, respectively) were administered at hourly intervals to reduce CIWA-Ar = 5, up to a maximum of eight administrations. Starting from D(2), the compounds were given twice a day in progressively decreasing doses during a maximum period of 13 days (D(end)). RESULTS: At h(8) (8 h after the first treatment of D(1)), therapeutic success (CIWA-Ar score