The Clinical Trials Directive, which came into force in May 2004 in order to create a harmonised framework for clinical drug research across Europe, is still hampering such research, according to new findings presented at the European Cancer Conference (ECCO 14).
Dr. Markus Hartmann, from European Consulting and Contracting in Oncology, Trier, Germany, said that his findings confirm other observations reporting a decrease in cancer clinical trials since the introduction of the Directive, and that this was likely to turn Europe into the poor relation of clinical academic medicine.
Many sponsor organisations, commercial and non-commercial alike, have criticised the Directive for the enormous increase in administrative burdens and cost that complying with it imposes. Under the Directive, the sponsor is an individual or organisation who has to take total legal and financial responsibility for the clinical trial, including paying for the medicine(s) under investigation while patients are on the study. “The reported data – stagnation in numbers of trials conducted by all sponsors, despite the increasing numbers of new drug therapies tested around the world, as well as the decreasing contribution of non-commercial sponsors – mirror these changes in the policies environment,” said Dr. Hartmann.
Dr. Hartmann set out to examine the effect of the Directive in six of the countries that are heavyweights in clinical research with more than 500 drug trials starting each year – the UK, Germany, France, The Netherlands, Italy and Spain – by looking at official trial authorisation rates both prior and post the implementation of the Directive into national legislation. “Trial authorisations as a quantitative parameter are much easier to assess than either improved quality of trials or better patient protection, which are also both declared aims of the Directive. The work is a first attempt to create a comprehensive picture at EU level of the outcome of the Directive three years after its coming into force,” he said.
“Because the follow-up time is quite short, it is still difficult to report final outcome figures, particularly given that some countries, such as France and The Netherlands, did not fully implement the Directive until 2006. But the data for non-commercial clinical research in general confirms that academic research, which represented around a quarter of all clinical trials of drugs before implementation, lost ground and represents now less than one fifth of newly started trials.”
Although the size of the effect is below initially reported estimates from different sponsor organisations, the current trend remains negative. However, latest figures reported by national authorities indicate that the pre-implementation level for new clinical trial authorisations may be achieved again in the coming 12 months, at least for commercial trials.