Traduction de «essai avec permutation des groupes » (Français → Anglais) :

4. If according to the protocol a clinical trial provides for the participation of specific groups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of the application for authorisation of that clinical trial on the basis of expertise in the population represented by the subjects concerned.

a description of the groups and subgroups of the subjects participating in the clinical trial, including, where relevant, groups of subjects with specific needs, for example . age, gender, participation of healthy volunteers, subjects with rare and ultra rare diseases;

the relevance of the clinical trial, including whether the groups of subjects participating in the clinical trial represent the population to be treated, or if not, the explanation and justification provided in accordance with point (y) of paragraph 17 of Annex I to this Regulation ; the current state of scientific knowledge; whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products; and, where applicable, any ...[+++] opinion formulated by the Paediatric Committee on a paediatric investigation plan in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council ;

19. Notes the approval by the Nuclear Suppliers Group of the US-India civil nuclear accord (and of country-regionplaceIndia’s unilateral declaration of its intention to abide by its non‑proliferation commitments and to uphold a voluntary moratorium on testing atomic weapons); calls on the Indian Government to transform its nuclear test moratorium into a legally binding commitment;

clinical trials on medicinal products intended for adults and on medicinal products intended for paediatric use, including at least one stage III clinical trial in which the new medicinal product is compared with previously authorised medicinal products used to treat the same or a similar condition in order to demonstrate the greater efficacy of the new medicinal product ; stage II and III clinical trials shall include a statistically sufficient number of women of all age groups concerned if the medicinal product is to be used to treat female patients; women-specific diseases and therapies shall be taken into account when designing the ...[+++] studies. The trials shall evaluate whether the medicinal product is efficacious for the respective indications, whether it is tolerated by women of all age groups, the appropriate dosage and its contra-indications and side-effects ,

(e) making an inventory and obtaining copies of existing Eco-labels, standards, test methods and studies that are relevant for the establishment of an Eco-label for the product group, taking into account the work done on related product groups, and estimating the costs of testing.