New European legislation designed to get the latest cancer therapies to patients more quickly is strangling independent research to determining which drugs work best and how they should be used, experts say. Cancer researchers gathered at the European Cancer Conference this week said the increased cost and paperwork spawned by the new regulations, which came into effect last year and are being implemented in countries now, have dramatically reduced the number of studies being conducted in Europe.
This decreases the opportunities for cancer patients to get the latest care by participating in research and slows down lifesaving scientific research advances, experts say.
Patrick Therasse of the European Organization for the Research and Treatment of Cancer presented an analysis Wednesday of the fallout from the regulations.
"For the previous 10 years, we had initiated about 30 new trials every year. Then in 2001, the year the directive was published, that dropped to 20, then 17, and so on. This year, it's down to seven," said Therasse, data director at the organization, one of the world's most prolific cancer research centers.
"It's an absolute disaster for research at all levels in Europe," said Dr. Peter Boyle, director of the International Agency for Research on Cancer, the U.N.'s cancer organization.
"The great majority of influential clinical trials in recent years have been those which have been done by academics. The directive will increase enormously the cost of doing these trials and it will take them out of the realm of feasibility of the academics on their own," Boyle said. "We risk being driven into the arms of the pharmaceutical industry more and more and we can't have the pharmaceutical industry dictating which trials we do."
"They think they are looking after the best interest of patients, but they are not because at the end of the day it stops important research from being done," said Boyle, adding that a Europe-wide collaboration of cancer researchers plans to reinvestigate the European Clinical Trials Directive and come up with an alternative.
The new regulations apply to research involving drugs and other therapies only, not to studies investigating the cause of disease or those tracking trends, according to the AP.
They aim to harmonize the standards of pharmaceutical studies across Europe, to accelerate the approval of important new drugs and protect patients by ensuring the quality of research.
Cancer specialists have been the loudest objectors. Experts say that makes sense because one-quarter of all clinical trials in Europe are cancer studies and trials initiated by universities and charities are particularly important in cancer because the complexity of the disease requires years of teasing out what treatments to use and when.
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