Call for network of Centres of Excellence in clinical research in Europe

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Sir—Investigators and sponsors in clinical research know that there are great differences in quality between clinical investigative sites in Europe, which vary in size, expertise, and organisation. This variation will be even more apparent when Europe is enlarged to 25 states in May. We would like to put forward the idea that there should be recognised networks of centres of excellence in clinical investigation for each specialty across the whole of Europe. All clinical trials should be referred to and conducted in these specialised centres. We advocate that criteria of excellence be drawn up by a group of research specialists (investigators and others from the European Agency for the Evaluation of Medicinal Products [EMEA] with knowledge of good clinical practice [GCP] and International Conference on Harmonisation [ICH]) and that investigative sites that meet these criteria be recognised. The register of such sites should be coordinated and inspected on a Europe-wide scale by the EMEA, whose inspectors will, in any case, be reporting the results of inspections at investigative sites as part of the 2001/20/EC Directive, which comes into force in May.1Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Commun 121: 33–44.Google Scholar, 2The Lancet Who's afraid of the European Clinical Trials Directive?.Lancet. 2003; 361: 2167Summary Full Text Full Text PDF PubMed Scopus (46) Google Scholar, 3Morice AH The death of academic clinical trials.Lancet. 2003; 361: 1568Summary Full Text Full Text PDF PubMed Scopus (19) Google Scholar, 4Meunier F Lacombe D European Organisation for Research and Treatment of Cancer's point of view.Lancet. 2003; 362: 663Summary Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 5Flavell DJ Sopsamorn UF Sullivan R European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287.Lancet. 2003; 362: 1415Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar Centres of clinical research excellence would provide: (1) high standards of ethical research practices for trial patients and the production of quality data for sponsors; (2) intellectual leadership in the specialty under study as proven by publications and peer recognition of these experts; (3) more influence over multinational pharmaceutical conglomerates for investigators within the network; (4) training and certification in GCP/ICH and the specialty under study for other centres wishing to become centres of research excellence; and (5) partnerships with collaborative investigative groups for the performance of academic and therapeutic strategic studies. Of course, such networks of centres would result in even more constraints for individual investigators who must conform to the criteria of excellence and work within the recognised networks. However, if we do not take action, non-commercial academic research will not survive future administrative constraints, and centres of investigation across Europe risk becoming nothing more than subcontractors of the pharmaceutical industry.3Morice AH The death of academic clinical trials.Lancet. 2003; 361: 1568Summary Full Text Full Text PDF PubMed Scopus (19) Google Scholar, 4Meunier F Lacombe D European Organisation for Research and Treatment of Cancer's point of view.Lancet. 2003; 362: 663Summary Full Text Full Text PDF PubMed Scopus (14) Google Scholar The financing of these networks will be a big issue; however, many feel that European Union (EU) financing favours research into basic science and new technology, and that, as a consequence, clinical research has become too dependent on the pharmaceutical industry. The EU claims to support investigative centres of excellence, but in practice the political will is not apparent. This lack of enthusiasm was seen in a recent initiative to establish a network of centres of excellence in AIDS: promoters were faced with such difficulties and insufficient financing that the project was abandoned. This, in our opinion, was a missed opportunity. We think that the public authorities must now take on their responsibilities and enable clinical investigators in Europe to maintain their place as world leaders in clinical research.5Flavell DJ Sopsamorn UF Sullivan R European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287.Lancet. 2003; 362: 1415Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar