New EU trials database is criticised for lack of openness
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《英国医生杂志》
Experts have warned that the European Union抯 decision to restrict access to a new clinical trials database to government regulatory authorities will make it more difficult to decide whether commonly used treatments are effective.
Dr Gerd Antes, head of the German Cochrane centre and spokesman for the German Network for Evidence Based Medicine, said that the information on the new European clinical trials database (Eudract) should be made available to the general public as well as to medical researchers.
"Making clinical trial registers available to the public is a scientific, economic, and ethical duty," he told the German weekly newspaper Die Zeit.
Under the European clinical trials directive, which comes into force on 1 May, all clinical trials on medicinal products for human use that take place in the 25 member states of the European Union have to be registered.
However, the information submitted will be confidential: only national and EU regulatory authorities as well as the European Commission will be able to find out what trials are going on, when and where.
The database—which will be linked with a European database of suspected unexpected serious adverse reactions reported during trials—has been set up to ensure greater protection for trial participants and patients receiving medicinal products.
But Dr Antes said that doctors and researchers should also have access to the information so that they can form a more accurate picture about the safety, side effects, and dangers of drugs.
"Chronic overoptimism reigns because of the falsified state of the data," Dr Antes said. He said that meta-analyses of published trials might be biased because of the tendency for researchers to publish only those trials in which a positive effect of new treatments had been shown, not trials that show no benefit or that have been prematurely ended.
More than a million clinical studies are estimated to have been carried out since 1948, but the results of only half these studies have been published in medical journals.
In response to growing concerns about adverse effects of secret clinical trials, the US government has established a database of all ongoing trials that is accessible to the general public (www.clinicaltrials.gov).
Dr Antes said that the US drug industry has been quick to reap the benefits of greater openness. "They have understood that they can save millions, because they are able to recruit trial subjects more easily," he said.
However, Thomas Porstner, lawyer and spokesman for the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie), insisted that drug companies needed to protect commercially sensitive information about drug developments.
Uwe Dolderer, the spokesman from the German pharmaceutical industry association, said that pharmaceutical companies were opposed to making information about ongoing clinical trials on the European database available to the general public for two reasons: the specialist information would be incomprehensible to the general public and to patients; and also, the information would fall into the hands of competitors.
"The information is meant for authorities. It is very specialised and patients and the general public would not be able to understand it. It could even lead to misunderstandings. Also, it is important for us as a company to keep information about the development drugs confidential for commercial reasons. Otherwise, our competitors would immediately use it," he said.(Vienna Jane Burgermeister)
Dr Gerd Antes, head of the German Cochrane centre and spokesman for the German Network for Evidence Based Medicine, said that the information on the new European clinical trials database (Eudract) should be made available to the general public as well as to medical researchers.
"Making clinical trial registers available to the public is a scientific, economic, and ethical duty," he told the German weekly newspaper Die Zeit.
Under the European clinical trials directive, which comes into force on 1 May, all clinical trials on medicinal products for human use that take place in the 25 member states of the European Union have to be registered.
However, the information submitted will be confidential: only national and EU regulatory authorities as well as the European Commission will be able to find out what trials are going on, when and where.
The database—which will be linked with a European database of suspected unexpected serious adverse reactions reported during trials—has been set up to ensure greater protection for trial participants and patients receiving medicinal products.
But Dr Antes said that doctors and researchers should also have access to the information so that they can form a more accurate picture about the safety, side effects, and dangers of drugs.
"Chronic overoptimism reigns because of the falsified state of the data," Dr Antes said. He said that meta-analyses of published trials might be biased because of the tendency for researchers to publish only those trials in which a positive effect of new treatments had been shown, not trials that show no benefit or that have been prematurely ended.
More than a million clinical studies are estimated to have been carried out since 1948, but the results of only half these studies have been published in medical journals.
In response to growing concerns about adverse effects of secret clinical trials, the US government has established a database of all ongoing trials that is accessible to the general public (www.clinicaltrials.gov).
Dr Antes said that the US drug industry has been quick to reap the benefits of greater openness. "They have understood that they can save millions, because they are able to recruit trial subjects more easily," he said.
However, Thomas Porstner, lawyer and spokesman for the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie), insisted that drug companies needed to protect commercially sensitive information about drug developments.
Uwe Dolderer, the spokesman from the German pharmaceutical industry association, said that pharmaceutical companies were opposed to making information about ongoing clinical trials on the European database available to the general public for two reasons: the specialist information would be incomprehensible to the general public and to patients; and also, the information would fall into the hands of competitors.
"The information is meant for authorities. It is very specialised and patients and the general public would not be able to understand it. It could even lead to misunderstandings. Also, it is important for us as a company to keep information about the development drugs confidential for commercial reasons. Otherwise, our competitors would immediately use it," he said.(Vienna Jane Burgermeister)