title: Access to regulatory data from the European Medicines Agency: the times they are a-changing.
abstract: 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.
authors.affiliation: Institute for Quality and Efficiency in Health Care, Im Mediapark 8 (KölnTurm), Cologne, 50670, Germany. beate.wieseler@iqwig.de
authors.forename: Beate
authors.initials: B
authors.lastname: Wieseler
authors.forename: Natalie
authors.initials: N
authors.lastname: McGauran
authors.forename: Michaela F
authors.initials: MF
authors.lastname: Kerekes
authors.forename: Thomas
authors.initials: T
authors.lastname: Kaiser
mesh_terms: D002986:Clinical Trials as Topic; D003219:Confidentiality; D016265:Conflict of Interest; D017277:Drug Approval; D004341:Drug Evaluation; D004345:Drug Industry / Q000592:standards*; D005060:Europe; D019317:Evidence-Based Medicine; D006291:Health Policy; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing; D017594:Publication Bias; D011786:Quality Control; D058028:Research Report / Q000592:standards*; D012196:Review Literature as Topic
chemical_list: D004364:Pharmaceutical Preparations