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Clinical Trial Transparency in Europe?

The regulatory body that licenses drugs for use in the European Union is devising a policy that will require the publication of some clinical trial data.

By | March 28, 2013

WIKIMEDIA, PARENTING PATCHMounting pressure for transparency in the drug approval process has led the European Medicines Agency (EMA), which is the European Union’s equivalent of the US Food and Drug Administration, to mandate the publication of clinical trial data submitted by drug companies. The EMA is expected to institute such a policy by January 1, 2014, according to Nature. Next month, UK trade groups and professional organizations will meet in London to talk about the impending increase in openness. “We should all stop discussing whether [the issue of clinical trial data transparency is] important or not and start having practical discussions about how we move forward,” Nicola Perrin, head of policy at the Wellcome Trust, told Nature.

British drug makers have faced pressure in recent years to be more forthcoming with clinical trial data that may better inform the public of the effectiveness and potential dangers associated with using the products. London-based GlaxoSmithKline and AstraZeneca, for example, have encountered legal problems regarding the concealment or misrepresentation of data pertaining to psychiatric drugs.

The particulars of the new policy are as yet unclear, and details such as how, when, where, and in what form data will be released to the public have yet to be ironed out.

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Avatar of: Joseph Ting

Joseph Ting

Posts: 1

July 14, 2013

 

I applaud the move towards raising the transparency of drug-company sponsored clinical trials and improved access to study data for independent appraisal. Selective outcome reporting leading to biased treatment and adverse effect estimates could be discerned by the re-evaluation of full outcome data that are made publicly available after publication of a clinical trial.

However it could be more efficient to use routine data monitoring committees to do this while the trial is being conducted. With their in depth understanding of study objectives and protocol, as well as access to fully disclosed results as they accumulate, these committees are well placed to gauge compliance with the collection and use of data for all prespecified outcomes from the start of a trial to its completion.  Employing these committees to review and approve the completeness of outcomes reported before publication would enhance the credibility of sponsored studies and make them less likely to be biased. It would assure that all sponsored trials are not influenced commercial imperatives that lead to biased and misleading conclusions.

The ability to monitor for selective data collection and use while the study is being conducted

improves the validity and credibility of submitted manuscripts, eliminates the need for resource

intensive post-publication re-evaluation, and averts disseminating biased estimates to journal

audiences in the first place.  It would be a shame to find that expensively acquired trial data had been manipulated after a study is published, when it is too late to apply the corrective. The tainted study is then rendered null, void , useless and disreputable.

Dr Joseph Y Ting clinical senior lecturer, Division of Anaesthesiology and Critical Care, University of Queensland, Brisbane, QLD 4067, Australia jysting@uq.edu.au

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