欧洲药品管理局积极筹备临床试验报告的公开化

幸福侠侣

欧洲药品管理局近日宣布，今后凡是在欧盟市场得到批准上市的药物都需要将其临床试验的报告进行公布，这将作为药品上市的前提条件之一进行规定。欧洲药品管理局于本月12日宣布了这项规定，并且这项规定将于今年10月1日起正式实施。欧洲药品管理局是第一个做出此项规定的药品管理组织，这是药物管理透明化进程中迈出的重要一步。

这项政策的宣布将为科研提供非常完备的临床实验报告，将大大有助于学术性科学研究的发展。举例来讲，在这项政策的支持之下，科学家们可以非常容易的获取到更为全面的临床实验数据，无论是对单一的临床实验进行研究还是对不同批次的临床实验进行比较，都可以非常有效的对现有成果进行改进和提高。(生物谷Bioon.com)

详细英文报道：

The European Medicines Agency (EMA) has agreed in principle to publish clinical-trials reports on any drug that receives marketing approval in the European Union - and to do so proactively, without the need for formal freedom-of-information request. The EMA is the first major drug regulatory agency to take such a step, which it sees as a significant move towards increasing transparency in the processes involved in approving medicines. The agency made its announcement in a statement on 12 June. It said that it will publish the details of the new policy in mid-July, and that the policy will become effective on 1 October.

The policy will make it easier for academics to carry out research for non-commercial purposes - for example, to reanalyse data from a clinical trial or compare data from different trials to work out the best treatment for a particular disease. "That's a good thing," says Síle Lane from the London-based lobby group Sense About Science, which has pressed hard for transparency in a campaign called Alltrials.

But she says that her group will not relax its vigilance until the detailed policy is published. "We still don't know how the EMA will monitor and audit its redaction policy, in which some information from clinical-trial reports can be withheld," she explains. "The EMA has been very vague about this."

Privacy concerns

The policy is the result of a long consultation process launched by the EMA in May 2013 following the publication of its first draft policy. This provoked a vociferous response from scientists and patient groups, who favour publication of clinical-trial results in full, and drug companies, which remain jittery about the possibility of losing out to competitors by sharing data they generated for their own purposes. Even drug companies outside Europe would have to agree to their clinical-trial reports being published by the EMA if they want their products to be marketed in the European Union.

Last October, EMA executive director Guido Rasi and his colleagues published an article in the New England Journal of Medicine arguing that appropriately managed access to clinical-trial data - including data on individual patients whose identity is protected - would help to increase the efficiency and cost-effectiveness of drug development, improve the ability to compare the effectiveness of different therapies and reduce duplication of effort.

But the agency is restricting the scope of its new policy to clinical-trial reports that do not include data on individual patients because of concerns over privacy (Sense About Science says secure anonymization cannot yet be guaranteed). EMA spokeswoman Monika Benstetter says that, in the long run, the agency still plans to broaden the policy to include all patient data, "but there has to be a stepwise implementation".

Tensions between stake-holders increased sharply last month when the EMA circulated a second, post-consultation, draft policy proposing that data be made available in a 'read-only' mode so that they could not be downloaded or printed, apparently in deference to industry concerns about unfair competition. But an outcry from the pro-transparency side prompted the agency to backtrack on this and to allow the information to be downloaded, saved or printed for academic and non-commercial research purposes.

The second draft also referred to a "redaction policy", under which some information might be withheld. Alltrials fears that this policy would give drug companies too much room to hold back important data, Lane says. But Benstetter says that the detailed policy, yet to be thrashed out, will specify the criteria on which requests from industry for redaction would be considered, and that the decision-making process in each case will be made transparent.