The European Medicines Agency says that it will publish by the end of this week the exact procedures by which members of the public can request documentation from clinical trials, along with what information they can expect to receive and when.

Agency spokeswoman Sabine Haubenreisser, Ph.D., said in a Nov. 22 interview that “basically anybody can request a clinical trial report,” and that the agency would have 15 business days to meet the request.

If the request involves extensive documentation, the EMA will have 15 additional days to meet it. If it is truly complex, involving huge numbers of copies, Dr. Haubenreisser said, “we would have a meeting with the applicant,” and work out a cost-based fee for the documents along with a response timetable. Trial documents supporting drug marketing applications can be hundreds of times longer than the journal articles summarizing the same information.

Dr. Haubenreisser said that the EMA expects many people – researchers and lay individuals alike – to make use of the new policy: “It’s possible that there will be quite a large number,” she said. However, the EMA has not added staff to deal with the potential onslaught of requests. To avoid redundant requests, Dr. Haubenreisser said answers will be published on the agency’s Web site. In the future, she said, clinical trial data, redacted only in areas pertaining to patient privacy or commercial confidentiality, will be published immediately on the agency’s Web site, barring the need to respond to specific requests.

The EMA will also spell out its redaction policies for the trial data this week, Dr. Haubenreisser said. Importantly, no adverse reaction data will be considered redactable. Until recently, adverse reaction data was to some degree at the discretion of the agency. Now, “we would release any adverse reaction data,” Dr. Haubenreisser said.

The new EMA trial data disclosure policy follows two cases that earned it chastisement this year from the European Ombudsman and caused it to revise its disclosure procedures.

In 2007, a request by Danish researchers seeking trial submissions on two antiobesity medications, rimonabant and orlistat, was denied by the agency because, it said, the data contained trade secrets. In 2008, an Irish man whose son had committed suicide after taking isotretinoin had requested data on the drug’s adverse effects, and was denied under a policy that allowed the EMA to keep confidential adverse reaction data that could be considered misleading. Both brought their complaints to the European Ombudsman, whose office investigates allegations of maladministration by EU agencies.

The Ombudsman issued a statement about the Irish case in May, and about the Danish case in June, concluding that in both cases the EMA’s actions ran contrary to EU transparency rules.

In May, an editorial in the Lancet (Lancet 2010;375[9728]:1753) weighed in support of the European Ombudsman’s position on the isotretinoin case. The journal, citing a recent letter from a trial investigator, also raised questions about the agency’s decision to grant marketing authorization to another drug, rosuvastatin, based on data that was not the primary end point of the clinical trial reviewed by the EMA; rather, it was a post hoc subgroup analysis from the same trial that led to the drug’s licensing. With increased transparency, The Lancet argued, such decisions could be better scrutinized.

The EMA’s new disclosure guidelines come as part of a broader effort by the agency to improve transparency and reduce conflicts of interest, Dr. Haubenreisser said. In October, the agency published stricter conflict-of-policies for members of its scientific committees that will come into effect next year. “There’s a whole package in relation to becoming more transparent,” Dr. Haubenreisser said.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

欧洲药品管理局(EMA)称其将在本周末前公布详细的资料索取程序、可获取资料的类型和获取时间。公众据此程序可索取临床研究文件。

EMA发言人Sabine Haubenreisser博士在11月22日接受采访时表示，对索取申请的受理时间一般为15个工作日，如索取的资料量较大，则增加15个工作日，如索取的资料量巨大且处理起来非常复杂，EMA将与申请人会面，并针对文件计算基于成本的费用及制定响应时间表。

EMA目前并没有额外人员来应对潜在的大量索取申请，未来将在其官网及时公布仅对涉及患者隐私或商业机密进行编辑处理的临床研究资料，以避免对各种具体索取需求进行一一回应。

本周EMA还将公布其编辑政策。任何不良反应资料将不可被编辑，并向公众公开，这具有重要意义。EMA之所以修改其信息披露规程，是因为其今年因2起拒绝披露信息的案件而受到来自欧洲监察使的惩罚。一起发生在2007年，丹麦研究人员要求索取利莫那班和奥利司他这两种减肥药的试验递交材料，但被EMA以资料包含商业秘密为由拒绝。一起发生在2008年，一名爱尔兰男子因其儿子服用异维甲酸后自杀而要求索取该药不良反应资料，但被EMA以保密机密性不良反应资料为由拒绝。欧洲监察使经调查称EMA的行为违反了欧盟透明度原则。

5月份《柳叶刀》杂志上的一篇社论 (Lancet 2010;375[9728]:1753)支持欧洲监察使在异维甲酸案件上的立场，并质疑EMA基于亚组分析结果(而非主要终点结果)做出的授予瑞舒伐他汀上市许可的决定。

这一最新信息披露政策是EMA为提高透明度和降低利益冲突所做努力的一部分，EMA期望公众善加利用。

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