In a strong and surprising action, the World Health Organization (WHO) made it crystal clear that researchers have an ethical mandate to publish all clinical trial results, regardless of their outcomes. This extends to past trials as well as future, and is the latest move in the battle for full disclosure.
According to its Statement on Public Disclosure of Clinical Trials Results, the WHO is calling for:
- Results from clinical trials to be publicly reported within 12 months of the trial’s end
- Results from previously unpublished trials to be made public
- Calls on organizations and governments to implement measures to achieve this
The action may put a stop to the practice of cherry picking outcomes for public disclosure. An investigation published in March found that during the following 12 months after completion of industry funded trials, only 17% of trial outcomes had been reported.
This number increased to just 41% after five years. Results for the trials funded by the National Institutes of Health produced only 8% disclosure after 12 months, and 38% after five years. It is logical to assume that the results presented to the public were supportive of study hypotheses.
The WHO’s statement comes as welcome news for consumers of medical care, and to the doctors that treat them. It may open the door for informed decision making about procedures and treatments. As it now, people were being blindly prescribed drugs and other treatments that have been the subject of research, but the outcome of that research has been withheld.
Read: Millions Affected as Scientists Hide Medical Test Results
Dr. 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. 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.”
The WHO’s statement came after hundreds of individuals and organizations called for full disclose of clinical trial results. However, the WHO has no legislative power. It will be the purview of companies, regulators, legislators, and those providing study funding to implement what the WHO is calling for.
Richard Stephens, cancer patient and clinical trial participant, said:
“The call from the WHO for old information to be shared is hugely welcome. Patients who choose to take part in clinical trials believe that by doing so, we are helping other patients in the future. We do not expect the knowledge to be kept secret or the help for others to be denied. It is immoral to recruit patients for clinical trials and then not report or share the results. We hope the call from the WHO will be taken up by everyone who can help uncover hidden information.”
This is good news, but look for fierce opposition from much of the pharma-medical establishment before any of this becomes confirmed policy.
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