European Commission considers revisions to clinical trials directive.

T he cancer community is hoping for important revisions to how clinical trials are run in Europe as the European Commission (EC) sets about overhauling the much-criticized Clinical Trials Directive. Adopted in 2001 and implemented by all EU member states in 2004, the directive aimed to create a harmonized framework for clinical research, as well as to improve patient safety and procedures for ethics review and data recording. But from the beginning, clinicians, scientists, and patient groups have criticized the directive, saying that it negatively affects clinical trials — particularly international, non-commercial trials run under the auspices of hospitals, institutions, and cancer networks. " While the aims of the directive were laudable — to harmonize clinical trials across Europe and improve patient safety — the reality has turned out to be quite different, " said president of the European Cancer Organization and a professor at the University of Technology in Dresden. " It is generally acknowledged that the Clinical Trials Directive has had a catastrophic effect on the independent evaluation and comparison of drugs and other therapies by academic clinical researchers. " Critics cite a huge increase in bureaucratic procedures and costs, leading to a reduction in the number of investigator-led trials, particularly multinational trials, and a slowdown in the delivery of cutting-edge clinical care to patients. In 2007, the EC held a conference to address these problems, and in 2008, it launched a longitudinal study to assess the directive's effect on the number, size, and nature of clinical trials, as well as on the workload, required resources, performance, and costs (see Stat Bite). Then, last fall, the EC launched a " public consultation paper " asking for answers to specifi c questions on the functioning of the directive. The deadline for submissions was January 8, and the EC is now reviewing responses. It is expected to draft either amendments or a new regulation to replace the directive, probably sometime in the summer. Major cancer organizations in Europe responded to the consultation paper, saying that the directive has caused particular problems for international trials, substantially reduced the amount of academic clinical cancer research in Europe for all types of treatments (surgery, radiotherapy, and systemic drugs), and hit certain groups of patients particularly hard. These groups include children, patients with rare cancers, patients who would benefi t from trials that improve existing treatments (and which, therefore, do not attract commercial funding), …