The World Health Organization has joined the debate about clinical transparency with a call to make all trial results publicly available.
The WHO has published a statement that indicates that says results from clinical trials should be reported within 12 months of the trial’s end, and also says results from previously unpublished trials should be made publicly available. It is the first time the agency has made a position on the issue.
“Our intention is to promote the sharing of scientific knowledge in order to advance public health,” said Dr Marie-Paule Kieny, the WHO’s assistant director-general for health systems and innovation.
“Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions.”
The health agency cites a study of large clinical trials completed before 2009 – using the ClinicalTrials.gov database – that revealed 23% had no results reported.
Similarly, a review of vaccine studies against five diseases conducted between 2006 and 2012 found that 29% were not published in a peer-reviewed journal within 24 months of completion, as recommended by the WHO.
While the WHO does not have any legislative power to back up its position, its position will carry significant weight in the ongoing debate about clinical trial transparency both in Europe – where the European Medicines Agency (EMA) recently published a long-awaited policy on disclosure – and elsewhere.
The agency wants all clinical trials to be registered on a publicly available, free-to-access database – before any patient receives treatment – with records updated promptly when they complete enrolment and are either completed or terminated.
Findings should be submitted for publication within 12 months and key outcomes added to the registry entry – or otherwise made available within 24 months via another public forum.
“WHO reaffirms the need for all clinical trials to be registered on a WHO primary clinical trial registry so that they can be accessible through the International Clinical Trials Registry platform,” said the agency in a statement.
“This will ensure transparency as to which clinical trials have occurred, and allow verification of compliance with public disclosure requirements.”
The statement was welcomed by Ben Goldacre, author and co-founder of the AllTrials campaign, although he sounded a note of caution.
“Withheld trials are already in breach of multiple existing codes, declarations, and even laws: delivering change will require more than good intentions. We need individual accountability, from robust public audit,” he said.