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Mary Rice, Directive Threatens Clinical Research in Europe, Critics Say, JNCI: Journal of the National Cancer Institute, Volume 96, Issue 13, 7 July 2004, Page 984, https://doi.org/10.1093/jnci/96.13.984
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The new European Union directive on clinical trials was scheduled to be implemented in all member states by May 1. However, many countries have not fully integrated the directive into clinical practice, and several noncommercial research organizations and patient groups throughout Europe are increasingly voicing their concern for the future of academic clinical trials.
The directive, which was adopted in 2001, is supposed to simplify and harmonize clinical trials work by creating a single legal framework for drug trials in member states (see News, March 19, 2003, Vol. 95, No. 6, p. 427). But even some members of the European Commission—the body where European directives are drafted—are now unhappy with how the legislation has turned out.
The heart of the problem lies in the increased obligations that the directive imposes on the sponsor of a trial—an individual or organization who must now take total legal and financial responsibility for the clinical trial. This responsibility will include paying for all drug and device costs (even the cost of routine noninvestigational aspects of the treatment) while patients are on study. For example, an academic sponsor, rather than the health service, would have to pay for all the drugs that a patient receives, including fully licensed drugs, if even one component of the treatment is experimental.
