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shawnsmith
Czech Republic
2048 Posts |
 Posted - 04/26/2010 : 16:12:08
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Here is an interesting story which may be of interest to readers here:
Safety regulations stalling clinical trials, says Canadian Medical Association
Mike Barber, Canwest News Service - April 26, 2010
http://www.nationalpost.com/news/story.html?id=2952505
The usefulness of clinical trials is threatened by cumbersome safety regulations that leave doctors swimming in paperwork, say the editors of the Canadian Medical Association Journal in the latest issue.
Dr. Paul Hebert, the journal's editor-in-chief, wrote that the current "one-size-fits-all" interpretation of the Good Clinical Practice guidelines, the international rule book that ensures safety in clinical trials, has stifled both academic and private-sector research in recent years, meaning patients "will have less access to new treatments.
"Regulations have grown so burdensome they are overwhelming the very things they are meant to support and safeguard," said Dr. Hebert. "Consequently, clinical research has been substantially decreased among industrialized countries."
The guidelines, which are interpreted for Canadian use by Health Canada, were last revised in 1996.
Dr. Hebert cited a report from Cancer Care Ontario which noted a 20-per-cent decline from 2007 to 2008 in cancer patients recruited into trials. The largest cancer research network inEurope saw the number of new trials plummet from 38 in 2001 to seven in 2005 after the introduction of the European Union's Medicine Act in 2004, while the cost of running a trial rose 85 per cent on average.
Dr. Elizabeth Eisenhauer, an oncologist at Queen's University in Kingston, Ont., and chair of the Canadian Cancer Research Alliance, said that while "on the surface you can't say it's a bad thing ... to have patients well looked after," the guidelines could afford some streamlining.
For example, clinical trials that hope to find new treatments with drugs that have been around for 30 years require the same paperwork and regulations as trials involving drugs being tested for the first time.
Further, all adverse reactions, regardless of how minor, must all be submitted for review by Health Canada. Dr. Eisenhauer said that the pure volume of harmless reactions that get reported often lead to more major ones getting lost in the mix.
The red tape is difficult enough to cut through for well funded pharmaceutical companies working on experimental drugs. But for university researchers, working with tight budgets and small staffs on projects that Dr. Hebert said are often far less riskier than private sector ones, the regulations can paralyze progress.
Dr. Eisenhauer said medical students thinking about focusing on clinical trials as a career will become increasingly dissuaded by the mountains of paperwork required and limited resources available to do so.
Dr. Hebert urged "international bodies, regulatory authorities, the academic community, and major granting agencies" to work together to "fix the system." The stakeholders should first find out what should be kept from the current guidelines, and work toward "study-specific" standards of care.
"I think there is really an opportunity for there to be a dialogue among stakeholders about what has been the good that's come from it and what we want to retain," said Dr. Eisenhauer, "but also where we need to be more evolutionary when it comes to clinical trials."
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Safety regulations stalling clinical trials
