Clinical research – publicity and transparency
The EMA will publish data from clinical trials of pharmaceutical companies
ABC Magazine based on Nature News: Drug-company data vaults to be openedThe call of researchers from all over the world to pharmaceutical companies with a request to publish the results of ongoing clinical trials has been sounding louder and more often lately.
There is an opinion that the largest pharmaceutical giants may hide fundamentally important data on the safety and effectiveness of medicines. For the first time, The European Medicines Agency (EMA) has taken a step towards greater openness of this information. It proposes to assign to pharmaceutical companies the obligation to publish the results of clinical trials.
On April 19, the largest players in the UK medical community will come together to discuss practical problems that may arise in connection with the disclosure of such information. It is expected that this meeting will be attended by members of the Wellcome Trust charitable organization, the Academy of Medical Sciences, the Association of the British Pharmaceutical Industry and the Association of Medical Research. Nicola Perrin, the head of the Wellcome Trust, hopes that this meeting will help the EMA "move from words to deeds."
In the United States, there has long been a practice requiring that clinical trials of all approved drugs be published in a public online register. Similar rules exist in some other countries, but not in Europe. At the same time, European researchers fear that the key results of such studies may be hidden from the public in the interests of pharmaceutical giants, which makes it difficult to fully assess the safety of a new drug and independently recheck it.
In particular, in recent years, the London office of the pharmaceutical company Astra-Zeneca has been convicted several times of concealing information about the safety of the drug, for example, about the side effects of the antipsychotic Seroquel (quetiapine). GlaxoSmithKline, also based in London, has paid billions of dollars in fines for concealing information about the side effects of the antidiabetic drug Avandia (rosiglitazone) and the antidepressant Paxil (paroxetine). The Cochrane collaboration has long been calling on the Swiss company Roche to disclose research data on the anti-influenza drug Tamiflu (oseltamivir) in order to independently double-check the effectiveness of the drug.
If the EMA experts manage to agree with the medical community and representatives of the pharmaceutical industry on the details of the disclosure of this information, the new policy may come into force as early as January 1, 2014. First of all, experts need to clearly define what information should be disclosed, to what extent, who will control its disclosure and who will have access to this information, which may contain personal data of study participants.
Portal "Eternal youth" http://vechnayamolodost.ru05.04.2013