Concern that new European policy on clinical trial data could be at risk

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AllTrials, the umbrella group campaigning to make all clinical trial results publicly available regardless of outcome, has written an open letter to the European Medicines Agency (EMA) expressing concern that its recently drafted policy on sharing clinical trial data could be at risk.

In April this year, the European Parliament voted for a new law to make results from clinical trials more easily available, a move that was welcomed by many as a step in the right direction. However, a further draft of the policy has introduced barriers to access to clinical trial data that, AllTrials claims, ‘would make the job of researchers who want to scrutinise it almost impossible’.

The group, which includes writer and columnist Dr Ben Goldacre, BMJ editor-in-chief Dr Fiona Godlee and Tracey Brown from Sense About Science on its steering committee, objects to terms of use which say that researchers can only access the data on screen and would be forbidden to print, share or save the data. It also would allow providers of clinical trial data to redact (edit or censor) information. AllTrials also points out that the draft policy could also add a ‘new and unpredictable risk of high legal costs into routine academic work’ by asking researchers to agree that legal action could be taken against them if the trial sponsor considers that they broke any of the conditions.

These concerns were raised with the EMA executive director Professor Guido Rasi, who responded insisting that the EMA is committed to increased transparency but at the same time aims to ‘discourage unfair commercial use of the data.’ This, he said, is why data can only be viewed onscreen and why there are restrictions on the terms of use. Furthermore, he said, each redaction will need to be agreed by the EMA.

This response has proven unsatisfactory to AllTrials, who, along with Glenis Willmott MEP, are calling for Professor Rasi to delay finalising the policy. ‘If the EMA allows its new policy to be based on out of date attitudes it risks losing the trust of patients, policy makers and healthcare professionals,’ AllTrials says. ‘We urge you to revise your policy to reflect your earlier support for the public interest in better medicine.’

AllTrials

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