WHO calls for more trial data transparency

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The World Health Organisation has weighed into the debate about data transparency, calling for disclosure of results from clinical trials, “whatever the result”.

The agency notes that in a study that analysed reporting from large studies (more than 500 participants) registered on ClinicalTrials.gov and completed by 2009, 23% had no results reported. These unreported trials included nearly 300,000 participants. Among studies of vaccines against five diseases registered in a variety of databases between 2006-2012, only 29% had been published in a peer-reviewed journal by the WHO-recommended deadline of 24 months following study completion.

Marie-Paule Kieny, WHO assistant director-general for health systems and innovation. said that “failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions”. She added that it “creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments”.

The WHO says results should be publicly reported within 12 months of a trial’s end, calling for data from previously unpublished studies to be made publicly available. It is pushing for organisations and governments to implement measures to achieve this.

Ben Goldacre, author and co-founder of the AllTrials campaign, said “this is a very positive, clear statement from WHO and it is very welcome. But withheld trials are already in breach of multiple existing codes, declarations, and even laws: delivering change will require more than good intentions”.

He added that “we need individual accountability, from robust public audit. Only this can show us exactly which researchers, companies, institutions, funders and treatments are the best – and the worst – for withheld data. With this individually accountable data we can finally reward good practice, learn from the best performers, and ensure that those withholding information are held fully to account”.