From Karen Shashok
Legislation in Spain, due to take effect on 1 May, will oblige drug companies to publish in scientific journals all the findings – both positive and negative – of the clinical trials they sponsor in this country. The law also states that the results of research on medications, when published, are to be accompanied by information on the funds (and their source) obtained by the authors for performing the research. Moreover, the new law establishes stricter procedures for the oversight of clinical trials by local clinical research ethics committees and a national coordinating centre.
Drug companies may be unwilling to comply with voluntary guidelines if they think that openness might hurt sales. But once patients who participate in clinical trials get used to the sort of transparency and reporting of results required by European directive 2001/20/CE, companies may be more inclined to follow voluntary ethical guidelines. Failure to do so could undermine consumers’ trust in their products.
Granada, Spain
