German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad
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German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad.
In comments submitted to EMA, Beate Wieseler, head of IQWiG’s Drug Assessment Department, explained:
"The decision on which data remain confidential is more or less left up to the study sponsors. This contradicts the spirit of the EU regulation and the aim of achieving transparency in clinical research. In addition, the non-publication or long delays in the publication of study results and methods would not be compatible with the ethical principles of studies in human beings, as, for example, stipulated in the Declaration of Helsinki."
IQWiG expressed the opinion that neither the results nor the methods of clinical studies are commercially confidential information, and that the public interest in the swift and complete publication of study data and documents to allow patients to thoroughly assess their treatment options should be paramount.
It pointed out that some sections of the EMA proposal are inconsistent with this change in paradigm outlined in the new EU regulation. For example, EMA has even left a loophole for publicly funded studies by allowing study sponsors to redact information if publication of study data could affect the acquisition of further third-party funds.
The planned publication of a study in a scientific journal would also suffice to withhold data. "This example is particularly illustrative of the imbalance in EMA’s proposal,” says Wieseler. “In our opinion, a research group’s wish to publish an article that might not even be freely accessible must give way to the public interest.” Her conclusion: “The non-publication of certain information must be the absolute exception. Those wishing to redact documents must in each case provide a precise justification to EMA, and EMA must meticulously evaluate these justifications.”