It used to be common to hear criticism about the FDA not approving new drugs fast enough, usually something that had been 'used in Europe' without issue.

That changed in 2004 with the Clinical Trials Directive, which came into force in May of that year in order to create a harmonized framework for clinical drug research across Europe, and some academics say it will make European schools also-rans in the research community.

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. Markus Hartmann, from European Consulting and Contracting in Oncology, Trier, Germany.

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.

Because the Directive changed the standards for trial reporting, many countries had to revise their way of compiling data and, as a result, the pre- and post-implementation statistics are not fully comparable. During the pre-implementation period, most authorities did not report many details. With the Directive’s coming-into-force, the new EudraCT database, currently only accessible by the authorities, now permits detailed analysis of the status of clinical drug research in Europe. But so far only some authorities have started to release detailed figures like research per different therapeutic indication, or per different sponsorship. In order to make this valuable data more easily available to sponsors and the research community, the European Commission, national authorities and the European Medicines Agency should improve reporting and widen public access to database statistics as part of their efforts to improve transparency, said Dr. Hartmann.

For both patients and doctors, non-commercial clinical trials offer a valuable method of defining the best place of new treatment options in medical practice. Trials conducted by acknowledged non-commercial sponsor organisations also provide for independent evaluations and comparisons of drugs, and offer urgently-needed options for access to innovative medicines in many niche indications as well as in countries with limited options of access to new drugs.

“As a knowledge- and science-based society of the 21st century, Europe should not accept stagnation in an issue so relevant for biomedical competitiveness. Biomedicine is a crucial area for innovation and economic development, and policy-makers and society should have a high level of interest in promoting a competitive legal environment for medical research in line with adequate support and funding for top-level clinical research. All those involved should do their utmost to prevent a lasting cutback of interest in, commitment to, and funding for academic clinical research,” said Dr. Hartmann.

- ECCO-the European CanCer Conference