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IQWiG, MRC and Cochrane back trial transparency campaign launches calling for all trial data to be reported supporters

A campaign calling for governments, regulators and research bodies to ensure all clinical trial results are published in full has launched and gained some heavyweight backing from the health and scientific community. has won support from a number of prominent bodies, including the UK's Medical Research Council (MRC), the German cost-effectiveness body IQWiG and research group the Cochrane Collaboration, and comes with the slogan “all trials registered, all results reported”.

It was set up by a group including Bad Pharma author and GP Dr Ben Goldacre, campaign group Sense About Science, the British Medical Journal (BMJ) and Oxford's University's Centre for Evidence-based Medicine following a series of high profile stories about clinical trial transparency during 2012.

These have been led by the controversy over Roche's decision to, so far, not release full clinical data for its influenza drug Tamiflu despite concerns it is no better than placebo, meaning the large figures governments paid for it during the swine flu pandemic could potentially have been a waste of money.

This led to a meeting hosted by the European Medicines Agency (EMA) and attended by Dr Goldacre (among others) in November last year to discuss the present situation, where Hans-Georg Eichler, the EMA's senior medical officer, said that the move towards transparency "is irreversible”.

An EMA report followed, reiterating this view, although it also considered that the exact way this can be done is still to be determined – something that is also an area of concern for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Roche has since said it is open to the idea of talking with one if its biggest critics, the Cochrane Collaboration, about setting up a multi-party advisory board, including experts from academia and industry, to review all the data behind Tamiflu.

Open access to such data still seems a long way off, however, and is hoping its campaign will both bring more attention to the cause and speed up its process.

Specific demands include:
• The publication of all results for all trials conducted – both past and future – on all treatments currently being used
• Competent legislation and regulations, with robust penalties and incentives, to ensure that this requirement is met
• All universities, ethics committees and medical bodies to recognise that under-reporting of trials is misconduct, and to police their own members to ensure compliance.

The profile of the campaign will be helped by such prominent supporter as IQWiG, which states on the website: “During the past years we have experienced that full availability of all clinical trials and all information on methods and results of these trials is essential for us to provide unbiased and meaningful assessments.

“Health technology assessment should be based on a full evidence base and thus requires registration and reporting of all trials, regardless of whether they are conducted by industry, academia, governmental organisations or others.”

There are also similar comments from the MRC and Drug and Therapeutics Bulletin, while Dr Fiona Godlee, editor of the BMJ – which announced last year it would no longer publish trials where all data is not available – said: “The evidence that much research goes unreported is overwhelming, putting patients at risk and wasting healthcare resources.”

17th January 2013

From: Research, Regulatory



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