The EU clinical trials directive, implemented in 2004, was intended to protect patients and improve research standards. But many investigators were worried that the labour intensive, bureaucratic, and expensive endeavour of running a clinical trial would become worse under the new rules.
In particular, academic researchers funded by grants, who have so far performed most cancer trials, were worried that their resources might no longer suffice to meet the requirements of the new directive.
An analysis of research since the directive suggests that many of those fears have been realised. For example, the number of new trials fell from 19 in 2004 to 7 in 2005 (63% decrease), and a third fewer patients were enrolled.
Simultaneously, trial costs increased by 85% and insurance costs from 70 to 140 million euros. Trial initiation was about five months slower than in 2004, while paperwork and documentation increased.
Instead of benefiting patients, the analysis suggests that the directive had hindered their access to new treatments.
"Our own experiences are in accordance with these findings," say the authors. The number of approved applications for both academic and company sponsored cancer trials in Helsinki has steadily decreased from 120 in 2002 to 70 in 2005 (42% decrease), but the workload of the ethics committee has increased.
These numbers seem to confirm the initial worries about the future of investigator initiated clinical cancer research, say the authors. Current and future patients with metastatic cancer should be worried. If research is thwarted the newest or most effective therapies may not become available rapidly, they warn.
New directives on clinical research are in preparation. Therefore, now is the time for action by physicians, patients, universities, and politicians to ensure that academic research can continue in Europe. It is in no one's interest if only commercial corporations have the resources to plan and carry out clinical trials, they conclude.