WHO to support OpenAccess to Clinical Trials Data

Dear Friends

Here is an excellent development in AllTrials, the international campaign that aims to transform the way scientists, universities and industries perform clinical trials.

The campaign has operated for 2 years to make the world aware of the problem in data transparency in clinical studies. Reports indicates that between 50-30% of clinical studies do not report their outcome at 12 months after their conclusion. Industry consider these data an intellectual property, slowing down the review from other researchers, and instead keeping a “private conversation” with the drug authorities.

AllTrials is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science. I talked about AllTrials extensively in this space, and I explained elsewhere why it is important, what it has achieved and why we should keep supporting it.

With the support of 80.000 signatories and over 500 organisations, the campaign already achieved important goals, like the new European Regulation for the collection and use of clinical trial data, that each EU country will transform in law by the end of 2017.

As the signatories keep growing in number, the international interest for the issue of transparency in clinical test has finally reached the World Health Organisation.

The WHO is seeking public comments on a draft statement, which you can find here.

This is potentially a really significant step. We have a chance to press the WHO to state unambiguously that the results of every trial that has taken place, as well as those from now on, must be reported.

If the statement covers past trials and timely reporting, as well as the ethical obligation to report, it will greatly assist AllTrials supporters around the world, particularly in countries where the campaign has not yet gained commitments from research funders and regulators.

So please do comment on the statement, to welcome this move by WHO and reiterate the importance of the statement for:

  • covering past trials
  • stress on a 12 month reporting deadline.

The consultation closes on 15th November. We’re working on our own response right now and will share that with you soon.

Thank you

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This post re-blogs an AllTrials newsletter, by Ian

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