Clinical trial data must be opened up, EMA says

European regulators, including representatives of the EMA and the MHRA, have called for open access to clinical trial data.

Writing in the journal PLoS Medicine, the authors pointed to confusion over the clinical value of Roche’s Tamiflu as a key example of poor access to trial data.

The articles accused Roche of exploiting ‘swine flu’ panic in order to gain major sales contracts on the basis of marketing claims not backed up with evidence.

The treatment of clinical trial data as commercially confidential, the articles said, can lead to major public health decisions being manipulated by drug companies.

An article in the journal by Peter Doshi and others argued that concerns over the use of Tamiflu justified a call for better sharing of clinical trial data.

In response, an article by European regulators, including the EMA’s Executive Director Guido Rasi and Senior Medical Officer Hans-Georg Eichler as well as MHRA’s Alasdair Breckenridge, argued that clinical trial data should be made available for independent analysis and the development of public health policy.

Doshi et al noted that the EMA and the US Centers for Disease Control and Prevention both asserted Tamiflu to be effective in reducing complications in people with influenza, whereas the FDA required a statement in the drug’s label that it had not been shown to do so.

The organisations based their views on a meta-analysis of ten clinical trials involving Tamiflu published in 2003 – apart from the FDA, which used data from the trials themselves.

As a result, Tamiflu supplies were stockpiled in many countries, but their clinical value is still contested.

Using freedom of information requests, Doshi et al obtained additional sections of the clinical study reports for Tamiflu. The article claimed that Roche refused to provide the additional data for the meta-analysis, and that their reasons “kept changing, and none seemed credible”.

Eichler et al agreed that clinical trial data should not be considered commercially confidential. They suggested that patient confidentiality could be protected by the development of new standards, and also recommended the adoption of quality standards for meta-analyses.

“We welcome debate on these issues and remain confident that satisfactory solutions can be found to make complete trials data available in a way that will be in the best interest of public health,” the authors concluded.