Institute for Quality and Efficiency in Health Care, Im Mediapark 8 (KölnTurm), Cologne, 50670, Germany.
Syst Rev. 2012 Oct 30;1:50. doi: 10.1186/2046-4053-1-50.
Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. In the case of the inhaled insulin Exubera, the manufacturer refused to cooperate and in 2007 we asked the European Medicines Agency (EMA) to provide the relevant CSRs, but EMA denied access. Other researchers have reported similar experiences.In 2010 EMA introduced a new policy on access to regulatory documents, including CSRs, and has also undertaken further steps. The new policy has already borne fruit: in 2011, by providing additional sections of relevant CSRs, EMA made an important contribution to a review of oseltamivir (Tamiflu).Unfortunately, speedy implementation of the new policy may be endangered. We define a CSR following the International Conference on Harmonisation (ICH) E3 guideline. Although this guideline requires individual patient data listings, it does not necessarily require that these listings be made available in a computer-readable format, as proposed by some regulators from EMA and other agencies. However, access to raw data in a computer-readable format poses additional problems; merging this issue with that of access to CSRs could hamper the relatively simple implementation of the EMA policy. Moreover, EMA plans to release CSRs only on request; we suggest making these documents routinely available on the EMA website.Public access to regulatory data also carries potential risks. In our view, the issue of patient confidentiality has been largely resolved by current European legislation. The risk of other problems, such as conflicts of interest (CoIs) of independent researchers or quality issues can be reduced by transparency measures, such as the implementation of processes to evaluate CoIs and the publication of methods and protocols.In conclusion, regulatory data are an indispensable source for systematic reviews. Because of EMA's policy change, a milestone for data transparency in clinical research is within reach; let's hope it is not unnecessarily delayed.
系统评价人员越来越多地试图获取监管临床研究报告（CSR），以纠正发表偏倚。例如，我们的组织，即卫生保健质量和效率研究所，通常要求制药商提供健康技术评估中考虑的研究的完整 CSR。然而，由于合作是自愿的，因此 CSR 仅可用于分析的一部分研究。就吸入型胰岛素 Exubera 而言，制造商拒绝合作，我们于 2007 年要求欧洲药品管理局（EMA）提供相关 CSR，但 EMA 拒绝提供。其他研究人员也报告了类似的经历。2010 年，EMA 出台了一项关于获取监管文件（包括 CSR）的新政策，并采取了进一步措施。新政策已经取得成果：2011 年，EMA 通过提供相关 CSR 的更多部分，为奥司他韦（Tamiflu）的审查做出了重要贡献。不幸的是，新政策的快速实施可能会受到威胁。我们按照国际协调会议（ICH）E3 指南定义 CSR。尽管该指南要求列出单个患者的数据，但不一定要求以计算机可读格式提供这些列表，EMA 和其他机构的一些监管机构提出了这一要求。然而，以计算机可读格式访问原始数据会带来其他问题；将此问题与 CSR 访问问题合并可能会阻碍 EMA 政策的相对简单实施。此外，EMA 计划仅在请求时发布 CSR；我们建议在 EMA 网站上定期提供这些文件。公开获取监管数据也存在潜在风险。在我们看来，当前的欧洲立法已经在很大程度上解决了患者保密的问题。通过透明度措施（例如实施评估利益冲突的程序以及发布方法和方案），可以降低其他问题（例如独立研究人员的利益冲突或质量问题）的风险。总之，监管数据是系统评价不可或缺的来源。由于 EMA 的政策变化，临床研究数据透明度的一个里程碑即将实现；希望它不会不必要地延迟。
