Clinical trials directive holding back research

Hartmann says his findings confirm those of other researchers who report a decrease in the number of cancer clinical trials since the directive came in to force and said this was likely “to turn Europe into the poor relation of clinical academic medicine”.

Many sponsor organisations, both commercial and academic, have criticised the Directive for the enormous increase in administrative burdens and cost it imposes.

Under the Directive, the sponsor has to take total legal and financial responsibility for the clinical trial, including paying for the medicine under investigation while patients are on the study. “The reported data, including 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 Hartmann.

Hartmann examined the effect of the Directive in six 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. He looked at official trial authorisation rates before and after the implementation.

Comprehensive picture

Speaking at the European Cancer Conference in Barcelona, Spain, Hartmann said, “The work is a first attempt to create a comprehensive picture at EU level of the outcome of the Directive, three years after it came into force.”

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, said Hartmann, “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.”

However, latest figures reported by national authorities indicate that new clinical trial authorisations may reach pre-Directive levels 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 full details. Now the EudraCT database permits detailed analysis of the status of clinical drug research in Europe. But so far only some authorities have started to release detailed figures, such as research per different therapeutic indication, or per different sponsorship.

Hartmann said this is important information. To make the 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.

“As a knowledge- and science-based society of the 21st century, Europe should not accept stagnation in an issue so relevant for biomedical competitiveness,” said Hartmann.

“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.”