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posted by mrcoolbp on Tuesday April 28 2015, @10:01AM   Printer-friendly
from the WHO-are-you dept.

The World Health Organization (WHO) has published a statement calling for public disclosure of all clinical trial results:

Before any clinical trial is initiated (at any Phase) its details are to be registered in a publicly available, free to access, searchable clinical trial registry complying with WHO's international agreed standards. The clinical trial registry entry should be made before the first subject receives the first medical intervention in the trial.

All clinical trial registry sites are to be updated as necessary to include final enrolment numbers achieved, and the date of actual study completion (defined as the last data collection timepoint for the last subject for the primary outcome measure). If clinical trials are terminated, their status is to be updated to note the termination, and to report the numbers enrolled up to the point of termination.

It is noted that several journals allow open access publication of clinical trial findings. Some journals have an explicit policy of supporting publication of negative trials. These 12 month and 24 month timeframes represent the longest possible acceptable timeframe for reporting and shorter timeframes are strongly encouraged. It should be possible in most instances for reporting to occur in shorter timeframes.

Unreported clinical trials conducted in the past are to be disclosed in a publicly available, free to access, searchable clinical trial registry. In addition it is desirable that unreported clinical trials are published in a peer reviewed journal.

The benefit of sharing research data and the facilitation of research through greater access to primary datasets is a principle which WHO sees as important. This statement is not directed towards sharing of primary data. However WHO is actively engaged with multiple initiatives related to data sharing, and supports sharing of health research datasets whenever appropriate. WHO will continue to engage with partners in support of an enabling environment to allow data sharing to maximise the value of health research data.

Pharmaceutical companies and researchers have brushed away "negative" results in the past. In the case of Tamiflu, the UK government stockpiled £424 million worth of the drug before learning of negative results hidden by F. Hoffmann-La Roche AGM. AllTrials has published reactions from "campaigns, doctors, patients and consumer groups" to the statement. PLOS Medicine has also published a rationale of the WHO's new position.

 
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  • (Score: 2, Interesting) by rondon on Tuesday April 28 2015, @11:54AM

    by rondon (5167) on Tuesday April 28 2015, @11:54AM (#176023)

    I think this is a great idea, but what are the odds that the WHO can out-lobby the pharmaceutical companies? Maybe the EU will go to bat for this and make the world a better place?

    Also, if this is implemented effectively, I think we will see an incredible rise in the garden-variety research fraud. I know it exists already, but now the incentive will be amplified.

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  • (Score: 2) by AnonTechie on Tuesday April 28 2015, @12:52PM

    by AnonTechie (2275) on Tuesday April 28 2015, @12:52PM (#176035) Journal

    I think this is a great idea, but what are the odds that the WHO can out-lobby the pharmaceutical companies ?

    Very true. I think the pharmaceutical companies will not comply unless they are forced to do so by law. And even then, the pharmaceutical companies will try their best to avoid publishing "negative" results.

    --
    Albert Einstein - "Only two things are infinite, the universe and human stupidity, and I'm not sure about the former."