EU clinical trials directive hampers research

2 Oct 2007

Europe wide legislation is hampering clinical drug research according to research presented by Dr Markus Hartmann, from European Consulting and Contracting in Oncology, Germany. The ‘Clinical Trials Directive’ was put into force in May 2004 to harmonise the framework for research, improve quality, and better protect patients.

Since then, many organisations and doctors have criticised the directive for the increase in administrative and financial burden that it has brought about. For example, it stipulates that an individual or organisation sponsoring a trial must take total legal and financial responsibility, including paying for the medicine under investigation while patients are on the study. Dr Hartmann said that his data, which showed stagnation in the numbers of trials and decreasing contribution of non-commercial sponsors, mirrored the new policy environment.

Six countries were assessed, by examining official trial authorisation rates both prior to and post implementation: the UK, France, Germany, The Netherlands, Italy and Spain. It was found that academic research, which represented around a quarter of all clinical trials of drugs before the directive was implemented, now represents less than one fifth of newly started trials.

For both patients and doctors, non-commercial clinical trials are an important method of defining the best place of new treatments 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 fields. They also offer important information to 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.

Hartmann’s findings echoed comments made earlier in the conference from the outgoing president of the European Cancer Organisation (Professor John Smyth) that political influence was hampering cancer treatment.