Traduction de «secrétariat du clinical trial » (Français → Néerlandais) :

La Division R&D (humain) participe aux réunions du groupe ad hoc de la CE et assure le secrétariat du Clinical Trial Facilitation Group (CTFG) des HMA.
De Afdeling R&D (humaan) neemt deel aan de vergaderingen van de ad-hocgroep van de EC en verzekert het secretariaat van de Clinical Trial Facilitation Group (CTFG) van de HMA.

Table 4: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical trial.pt (460563) 7 exp clinical trial/ (606505) 8 or/1-7 (718664) 9 (clinic$ adj trial$).tw (146686) 10 ((singl$ or doubl$ or treb$ or tripl$) adj (blind$3 or mask$3)).tw (105209) 11 Placebos/ (28712) 12 Placebo$.tw (125428) 13 Randomly allocated.tw (12231) 14 (allocated adj2 random).tw (654) 15 9 or 10 or 11 or 12 or 13 or 14 (312732) 16 8 or 15 (842155) 17 Case report.tw (155883) 18 Letter.pt (688664) 19 Historical article.pt (263287) 20 Review of reported cases.pt (0) 21 Review,multicase.pt (0) 22 17 or 18 or 19 or 20 or 21 (1098644) 23 16 not 22 (822810) 24 Breast/ or Breast Diseases/ (30717) 25 Neoplasms/ (216644) 26 24 and 25 (535) 27 (breast$ adj5 neoplasm$).tw (1588) 28 (breast$ adj5 cancer$).tw (135654) 29 (breast$ adj5 carcin$).tw (31778) 30 (breast$ adj5 tumo$).tw (23438) 31 (breast$ adj5 metasta$).tw (16580) 32 (breast$ adj5 malig$).tw (7361) 33 exp Breast Neoplasms/ (171606) 34 exp Carcinoma, Ductal, Breast/ (8460) 35 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 (207174) 36 mammography.mp (23598) 37 screening.mp (274211) 38 36 or 37 (288429) 39 23 and 35 and 38 (2326) 40 limit 39 to (yr=" 2008 -Current" and " all adult (19 plus years)" and (dutch or english or french)) (241) 41 from 40 keep 1-241 (241) 42 from 41 keep 1-241 (241) CENTRAL Breast neoplasms (MESH) and early detection (MESH) or 61 mammography (MESH) (manual limit 2008-2010) in title , abstracts or key words
Table 2: Search for additional RCTs Search Benefit and harms of mammography screening (40-49 y) questions Note Specific search for RCT’s Date 27/04/2010 Keywords Breast neoplasms (MESH), mass screening (or early detection) (MESH), mammography (MESH) Medline 1 Randomized controlled trials/ (66083) Medline (OVID): (OVID): 2 Randomized controlled trial.pt (289038) Filter Filter 3 Random allocation/ (67885) RCT RCT 4 Double blind method/ (105956) 5 Single blind method/ (13834) 6 Clinical trial.pt (460563) 7 exp clinical trial/ (606505) 8 or/1-7 (718664) 9 (clinic$ adj trial$).tw (146686) 10 ((singl$ or doubl$ or treb$ or tripl$) adj (blind$3 or mask$3)).tw (105209) 11 Placebos/ (28712) 12 Placebo$.tw (125428) 13 Randomly allocated.tw (12231) 14 (allocated adj2 random).tw (654) 15 9 or 10 or 11 or 12 or 13 or 14 (312732) 16 8 or 15 (842155) 17 Case report.tw (155883) 18 Letter.pt (688664) 19 Historical article.pt (263287) 20 Review of reported cases.pt (0) 21 Review,multicase.pt (0) 22 17 or 18 or 19 or 20 or 21 (1098644) 23 16 not 22 (822810) 24 Breast/ or Breast Diseases/ (30717) 25 Neoplasms/ (216644) 26 24 and 25 (535) 27 (breast$ adj5 neoplasm$).tw (1588) 28 (breast$ adj5 cancer$).tw (135654) 29 (breast$ adj5 carcin$).tw (31778) 30 (breast$ adj5 tumo$).tw (23438) 31 (breast$ adj5 metasta$).tw (16580) 32 (breast$ adj5 malig$).tw (7361) 33 exp Breast Neoplasms/ (171606) 34 exp Carcinoma, Ductal, Breast/ (8460) 35 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 (207174) 36 mammography.mp (23598) 37 screening.mp (274211) 38 36 or 37 (288429) 39 23 and 35 and 38 (2326) 40 limit 39 to (yr=" 2008 -Current" and " all adult (19 plus years)" and (dutch or english or french)) (241) 41 from 40 keep 1-241 (241) 42 from 41 keep 1-241 (241) CENTRAL Breast neoplasms (MESH) and early detection (MESH) or 61 mammography (MESH) (manual limit 2008-2010) in title , abstracts or key words

ÿ Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the princinciples that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Ÿ
" Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.‰

Soumission auprès de l’AFMPS de 131 Clinical Trial Applications (CTA) pour des médicaments oncologiques, principalement pour des études cliniques de phase II et III ;
Indiening bij het FAGG van 131 Clinical Trial Application (CTA’s) voor oncologische geneesmiddelen, voornamelijk voor fase II en III klinische studies;

L’organisation du Clinical Trials Facilitation Group (CTFG) et du Pharmacovigilance Inspector’s Working Group (PhVWP) était une initiative spécifique de l’AFMPS.
De organisatie van de Clinical Trials Facilitation Group (CTFG) en de Pharmacovigilance Inspector’s Working Group (PhVWP) waren een specifiek initiatief van het FAGG.

Le suivi et l’analyse de l’impact d’initiatives au niveau de la Commission européenne (CE) ainsi que les évolutions, en fonction de l’European Medecines Agency (EMA) et de l’Heads of Medecines Agencies (HMA), de la feuille de route restent importants à suivre, plus précisément la nouvelle Directive Clinical Trial, la Better Regulation (médicaments vétérinaires) et le Pharmaceuticals Pack (en particulier en ce qui concerne la pharmacovigilance et les médicaments falsifiés).
De opvolging en impactanalyse van initiatieven ter hoogte van de Europese Commissie (EC) en de evoluties in functie van de European Medicines Agency (EMA) en de Heads of Medicines Agencies (HMA) Roadmap blijven belangrijk om op te volgen, meer bepaald de nieuwe Clinical Trial Richtlijn, de Better Regulation (diergeneesmiddelen) en het Pharmaceuticals Pack (in het bijzonder aangaande farmacovigilantie en vervalste geneesmiddelen).

La publication d’une directive relative aux «Exploratory Clinical Trials» et les différentes présentations aux divers forums internationaux y ont certainement contribué.
De publicatie van een richtlijn met betrekking tot “Exploratory Clinical Trials” en de verschillende presentaties als gastspreker op diverse internationale fora hebben hier zeker toe bijgedragen.

Des questions de recherche nécessitant un financement d’études interventionnelles diagnostiques ou thérapeutiques (clinical trials), seront dans tous les cas exclues.
Onderzoeksvragen die een financiering van diagnostische of therapeutische interventionele studies (clinical trials) vereisen, worden in elk geval uitgesloten.

31. McKinlay S, White RA, Diethrich EB, Fogarty TJ, Zarins CK, Hopkins LN, et al. Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial.
Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial.

22. Cuzick J, Edwards R, Segnan N. Adjusting for non-compliance and contamination in randomized clinical trials.
21. Cuzick J, Edwards R, Segnan N. Adjusting for non-compliance and contamination in randomized clinical trials.