World Health Organisation calls for full trial transparency
pharmafile | April 14, 2015 | News story | Research and Development, Sales and Marketing | Ben Goldacre, EU, WHO, World Health Organisation, alltrials, clinical trials, sense about science, transparency
The World Health Organization has thrown its weight behind clinical trial transparency in a new statement on its position.
WHO says that researchers have an ‘ethical imperative’ to report results from clinical trials and that results should be made publicly available within 12 months of the study’s end – although it notes that it should be possible for reporting to occur in shorter timeframes in ‘most instances’.
It also says that results from previously unpublished trials should be made publicly available, and calls on organisations and governments to implement measures to achieve this.
The statement’s authors outlined the thinking behind the position in an article published in PLoS Medicine, saying: “It is unethical to conduct human research without publication and dissemination of the results of that research. In particular, withholding results may subject future volunteers to unnecessary risk.”
They add that it also affects understanding of the scientific state of the art, leads to inefficiencies in resource allocation, creates indirect costs for public and private entities – including patients paying for ‘suboptimal or harmful treatments’ – and it potentially distorts regulatory and public health decision-making.
Although WHO doesn’t have legislative power to enforce this position, its statement is a huge boost for groups such as AllTrials, who have been campaigning for transparency in all clinical studies for some time.
Síle Lane who is the director of campaigns at Sense About Science, the co-founding organisation of AllTrials, says: “Such a strong position is a fantastic acknowledgement of the thousands of patients, doctors and researchers who have been urging everyone who has a role in trial reporting to do what they can to make all clinical studies count. The WHO has stated unequivocally that the era of secrecy around clinical trial results must end.”
However Dr Ben Goldacre, also co-founder of AllTrials, is more cautiously optimistic: “This is a very positive, clear statement from WHO, and it is very welcome,” he says. “But 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. 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.”
Transparency has been on the EU’s agenda for a while now – the EU Clinical Trial Regulation was voted into law in April 2014 and states that information from clinical studies should generally not be considered commercially confidential. It will mandate pharma to release more of its clinical trial data, and comes into force in May next year.
However, its proposals have met with a mixed response and their implementation was delayed several times.
WHO’s initial position on transparency was outlined in 2005, when it called on all clinical trials to be registered in a publicly available, free to access, searchable registry before they begin. It also established the International Clinical Trials Registry Platform to help achieve this.
George Underwood
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