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Multicentre clinical trials

1999; Elsevier BV; Volume: 353; Issue: 9156 Linguagem: Inglês

10.1016/s0140-6736(05)75041-8

1474-547X

Silvio Garattini, Vittorio Bertelè,

Health Systems, Economic Evaluations, Quality of Life

C Cornu and colleagues (Jan 2, p 63)1Cornu C Cano A Pornel B Melis GB Boissel JP Could institutional trials exist in Europe?.Lancet. 1999; 353: 63-64Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar describe the difficulties and administrative hurdles of implementing a multicentre clinical trial in Europe. We fully agree that implementation of such trials is probably the utmost priority in European clinical research. An inappropriately small number of patients is one of our most frequent criticisms of non-industry-sponsored clinical trial applications at the Ethics Committee of the Vienna University Medical Faculty. Applicants are often advised to increase sample size by cooperating with other European centres to enhance recruitment capability. The concomitant increase in the administrative burden, however, often leads to long delays, sometimes to the point of aborting the trial, as was vividly illustrated by the example of Cornu and colleagues.1Cornu C Cano A Pornel B Melis GB Boissel JP Could institutional trials exist in Europe?.Lancet. 1999; 353: 63-64Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar These delays are surprising, since in an age of rapid electronic communication Europewide clinical trials should be easier to implement than ever before. What then stands in the way of a pan-European clinical research initiative? We propose that the resistance to harmonisation of research regulations and administrative procedures is largely found in the selfserving interests of national bureaucrats, ethics committees and other dignitaries for whom regional and national parochialism creates a cherished sphere of influence. These notables have little to gain and much to lose from pan-European harmonisation that would transfer powers to a supranational body. The frequently invoked “cultural differences” across Europe, purported to justify national differences in clinical trial regulations, is little more than a thinly veiled pretext for protection of group interests. How should academic clinical medicine respond? Foremost, by using influence and prestige to help dispel the myth that national differences in European research (and drug) regulations in a way benefit patients or society at large. At present, a European Directive2European Commission, Proposal for a European Parliament and Council directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.COM(97) 369 final. EC, BrusselsSept 3, 1997Google Scholar on clinical trial conduct is being considered by the European Parliament and the Council of Ministers, which proposes pan-European harmonisation of various aspects of drug research. Surprisingly, the initiative originates from Directorate General (DG) III within the European Commission, which is responsible for industrial affairs, rather than DG XII, which deals with research. In any case, this effort deserves the full support of academic medicine. However, at present, lobbying for this document has been largely left to the pharmaceutical industry. Although we recognise that big pharmacological interests are not always congruent with those of the academic medical community, academia would be well advised to support the idea of this proposal, even against the interests of local dignitaries.