Go Tell the World

Citizens of democratic societies are increasingly demanding transparency, whether in politics, public services or business. Members of Parliament in the United Kingdom now have to account for their expenses and the National Health Service has had to acknowledge its problems with standards of care in certain areas and lay out its plans to remedy these issues. In the business arena, the movement for greater transparency affects none more so than the pharmaceuticals sector. The Association of the British Pharmaceutical Industry has announced new measures to monitor compliance with its Code of Practice with regard to clinical trial registration and publishing of summary data within a year of marketing authorisation <<http://www.abpi.org.uk/media-centre/newsreleases/2013/Pages/270213.aspx>>.

Various ways of making clinical trial results publicly available, irrespective of whether data are positive or negative, are already familiar: publication in peer-reviewed journals in accordance with Good Publication Practice Guidelines, online registries such as ClinicalTrials.gov, and company initiatives such as GlaxoSmithKline’s Clinical Study Register. But what about the more fundamental idea of publishing full Clinical Study Reports (CSRs), or even full original datasets? The European Medicines Agency has been contemplating for some time making CSRs for marketed compounds available on its website as part of an open access data policy.

Roche has stated it supports the publication of CSRs by regulatory authorities <http://www.pharmatimes.com/article/13-02-27/Critics_unconvinced_as_Roche_expands_access_to_data.aspx>>. This has attracted criticism from commentators who say it does not go far enough. GlaxoSmithKline wants to make more clinical trial results publicly available, as reported in the New York Times a few months ago <<http://www.nytimes.com/2012/10/11/business/glaxo-opens-door-to-data-on-its-research.html?ref=glaxosmithklineplc&_r=0>>, and has recently backed the AllTrials campaign for full data transparency, stating it will publish CSRs for all of its medicines once they have been approved or discontinued from development <<http://www.pharmatimes.com/Article/13-02-06/GSK_backs_AllTrials_campaign.aspx>>. The AllTrials campaign, launched by the website Sense about Science in conjunction with the author Ben Goldacre and the BMJ, has also been endorsed by NICE and the British Medical Council.

If data are fully shared, it is hoped that patients may benefit from more open access to results on the medicines they are taking. Healthcare professionals and doctors will not only be able to read the full results of clinical trials, but will be able to re-analyse the data, either alone or in combination with data from other studies. The European Medical Writers Association has started looking to the future in its publication, Medical Writing, discussing standardised processes for data sharing so that interested parties can conduct secondary data analyses efficiently. It says pitfalls will need to be addressed by removing potential identifying data and ensuring metadata are included with the trial data, and indicates that online services such as the Dryad data depository can be useful in ensuring a mechanism for data sharing is available.

Only time will tell whether more pharmaceutical companies will back the call for publishing of CSRs, but it seems that the movement for transparency will continue gathering momentum, and the industry should prepare itself for change in this direction. This topic will continue to be a source of debate, as it has been claimed that the initiative may stifle innovation in drug development. Scepticism has also been expressed in some quarters as to whether the new willingness to share data will truly result in full transparency, or whether, as in the case of ClinicalTrials.gov, a proportion of registry entries will remain without results after the agreed timeline has passed. The healthcare community is hoping for benefits for patients and doctors, including more informed decisions on drug prescribing.

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