Scientists beg EU to repeal new rules for clinical trials
http://www.100md.com
《英国医生杂志》
Thousands of academics and scientists across Europe are appealing to the European Union to repeal new legislation that they fear could seriously damage the prospects of non-commercial, academically led, patient focused clinical research.
Opponents of the new rules, which are due to come into effect on 1 May, are mounting a last ditch campaign. In the space of just two weeks they have collected signatures from over 2000 medical researchers, including some 150 professors of medicine and science, across Europe and further afield.
Their criticism is directed at the description of "sponsor" in the European Union抯 good clinical practice legislation. In future, any individual or organisation in this position would have to take full legal and financial responsibility for the clinical trial. This would include covering the cost of all drugs and devices while patients are being studied.
They point out that, although the pharmaceutical industry can provide this level of funding to support commercially inspired trials while developing potentially highly profitable new drugs, charities and academic institutions cannot.
The campaign is being led by the Brussels based Breast International Group and the Irish Clinical Oncology Research Group.
Dr Brian Moulton, who is coordinating the campaign on behalf of the Irish group, maintains that cancer research in particular would be badly hit by the new definition. "Almost half of all oncology research in Europe is academic led, and the major advances that have been made in breast cancer treatment in the past 18 months have been non-commercial," he explained.
In an ironic twist, the new rules could also mean the end of a number of non-commercial trials that are currently being funded by the European Union from its multibillion pound research budget. They would also make the union a less attractive venue for research investment, damaging EU leaders?medium term objective of making Europe the world抯 most competitive, knowledge based economy by 2010.
Critics acknowledge that the legislation was not intended to place potentially insurmountable obstacles to non-commercial clinical research. But they are angry that this could be the unintended consequence as there was not wider consultation with the academic and medical communities when civil servants were drafting the legal text.
The campaigners are lobbying every single MEP and European commissioner. However, it would be unprecedented if EU governments and decision makers agreed to repeal the legislation (which is designed to ensure high quality standards in European research) before it even came into force.
But there is a glimmer of hope that the legislation might be accompanied by a guidance document that could indicate that some flexibility should be exercised when its provisions on sponsors are being implemented.
A European Commission spokesman confirmed that it was committed to the new requirement in the legislation that there be a clear chain of responsibility.
"We want one identifiable person in charge of a project. But within that it is possible for certain responsibilities to be delegated. We will listen to problems and explore with member states what can be done," he said.(Brussels Rory Watson)
Opponents of the new rules, which are due to come into effect on 1 May, are mounting a last ditch campaign. In the space of just two weeks they have collected signatures from over 2000 medical researchers, including some 150 professors of medicine and science, across Europe and further afield.
Their criticism is directed at the description of "sponsor" in the European Union抯 good clinical practice legislation. In future, any individual or organisation in this position would have to take full legal and financial responsibility for the clinical trial. This would include covering the cost of all drugs and devices while patients are being studied.
They point out that, although the pharmaceutical industry can provide this level of funding to support commercially inspired trials while developing potentially highly profitable new drugs, charities and academic institutions cannot.
The campaign is being led by the Brussels based Breast International Group and the Irish Clinical Oncology Research Group.
Dr Brian Moulton, who is coordinating the campaign on behalf of the Irish group, maintains that cancer research in particular would be badly hit by the new definition. "Almost half of all oncology research in Europe is academic led, and the major advances that have been made in breast cancer treatment in the past 18 months have been non-commercial," he explained.
In an ironic twist, the new rules could also mean the end of a number of non-commercial trials that are currently being funded by the European Union from its multibillion pound research budget. They would also make the union a less attractive venue for research investment, damaging EU leaders?medium term objective of making Europe the world抯 most competitive, knowledge based economy by 2010.
Critics acknowledge that the legislation was not intended to place potentially insurmountable obstacles to non-commercial clinical research. But they are angry that this could be the unintended consequence as there was not wider consultation with the academic and medical communities when civil servants were drafting the legal text.
The campaigners are lobbying every single MEP and European commissioner. However, it would be unprecedented if EU governments and decision makers agreed to repeal the legislation (which is designed to ensure high quality standards in European research) before it even came into force.
But there is a glimmer of hope that the legislation might be accompanied by a guidance document that could indicate that some flexibility should be exercised when its provisions on sponsors are being implemented.
A European Commission spokesman confirmed that it was committed to the new requirement in the legislation that there be a clear chain of responsibility.
"We want one identifiable person in charge of a project. But within that it is possible for certain responsibilities to be delegated. We will listen to problems and explore with member states what can be done," he said.(Brussels Rory Watson)