Clinical research infrastructures and networks in France: report on the French ECRIN workshop.
A meeting was organised in Paris on 13 September 2004, to provide an in-depth description of the state of the art in institutional clinical research infrastructures and their environment in France. This meeting was scheduled within the ECRIN (European Clinical Research Infrastructures Network) project, funded by the European Union (6th Framework Programme). Ten items were addressed: (i) centres and networks; (ii) funding and sponsoring of clinical research; (iii) ethics; (iv) legislation and regulation; (v) adverse-event reporting and drug dispensing; (vi) methodology, data management and data monitoring; (vii) quality management and audits; (viii) communication with investigators, sponsors and participants; (ix) transparency and registration of clinical studies; and (x) education and careers. This description, together with parallel workshops held in other countries using a similar pattern, helped prepare a comparative analysis enabling better identification of the bottlenecks for multinational research in Europe, and define the most relevant approaches to harmonisation and the services required to support the role of sponsors in transnational studies.
Demotes-Mainard
Jacques
J
Centre d'Investigation Clinique; INSERM-CHU de Bordeaux, Bordeaux, France. demotes@bordeaux.inserm.fr
Chêne
Geneviève
G
Libersa
Christian
C
Pignon
Jean-Pierre
JP
D035843:Biomedical Research / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D003625:Data Collection; D004282:Documentation; D005602:France; D006761:Hospitals; D007391:International Cooperation; D011786:Quality Control; D012109:Research Support as Topic; D013333:Student Health Services