After a 18-month saga, the European Medicines Agency (EMA) has approved the details of a new system allowing researchers to scrutinize unpublished data from clinical trials. Scientists and transparency campaigners welcomed the decision as a great step forward, but expressed continuing concerns, especially on information that could be redacted before the clinical study reports are divided.
EMA is the "first entity in the world" to introduce such rules, executive director Guido Rasi said at an event in the European Parliament earlier this week, adding that the agency is "establishes new standards for transparency. " the plan, which was approved yesterday at a meeting of the board of management in London, "represents a real shift to ensure that research data is shared and regularly re-used effectively in the public interest," agrees Carl Heneghan , director of the Centre for Evidence Based Medicine at Oxford University and co-founder of the AllTrials campaign, in a statement released yesterday.
the decision of the EMA is part of a great battle for who has the right to view and analyze data from clinical studies of drugs, vaccines and other medical products. published newspaper articles often contain the main results of these studies, but lack of data and information detailed information on the study design, effectiveness, and safety analysis, which could shed a different light on the results when analyzed by others also, some tests are not published at all. The AllTrials campaign argued that the details of each test shall be publicly available for anyone to examine. The industry balked at the idea, although some companies have recently committed to greater openness.
The new rules apply to data presented in the context of authorization applications on the market after 1 January 2015. "Access to clinical data allow third parties to verify the analysis and original conclusions, to conduct further analysis and to examine the positions of the regulatory authority and to challenge, if necessary , "states the policy. In return, the agency expects to receive a copy of the articles resulting secondary analysis before publication, and said they should also be in the public domain.
To avoid interfering with the decisions of regulatory bodies, however, the data will be shared only after the European Commission has taken a decision on a particular application, "which implies a delay of about 18 months, "EMA said in a memorandum.
For the relief of outraged activists, the agency scrapped recent plans that allowed users to view data only on the screen. As part of the future system, scientists will be able to download, save and print searchable clinical reports "for purposes of academic and other non-commercial research," while the data will be available on the screen for all other users after a simple registration process.
However, transparency campaigners are still concerned that the conditions of use are individual researchers "vulnerable to prolonged legal battles with large companies, "and that information may be blacked out before the clinical study reports are divided. Appendix 3 lists the elements of the policy that could be redacted from the clinical study reports, as it can be considered" confidential business information " . This includes, for example, details of proprietary information on analytical methods, or so-called exploratory parameters that could provide potential off-label uses indexes for competitors.
EMA expects that about 5% of the content of a report could be removed in this way, Rasi said, adding that the last word on what will be redacted responsibility of the organization, even if the company disagrees. But "the list of factors that would justify the writing is too expansive ..." says Ilaria Passarani, head of the department of food and health for the organization of European consumers BEUC in Brussels, in an e-mail to Science Insider. "the attitude of the EMA for redaction must be independently verified to ensure overzealous approaches do not hinder access to important information," said Heneghan.
the policy will be reviewed in June 2016 and serve as a bridge until the deployment of the revamped EU regulations clinical trial provides a legal basis for the publication of clinical trial results, but will enter into force at the earliest in May 2016 . (This means that the results of the first tests under the new law will be publicly available from 2019 or 2020.) at a later stage, the BMA also plans to make available data for each patient.
0 Komentar