WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Tr

barbc56 · Apr 15, 2015

Haven't had a chance to read this but it looks like a step in the right direction.

On April 14, 2015, the World Health Organization (WHO) published a new statement on the public disclosure of clinical trial results (S1 Text) [1]. The WHO statement not only re-affirms the ethical imperative of clinical trial results reporting, it also defines reporting timeframes, calls for results-reporting of older but still unpublished trials, and outlines steps to improve linkages between clinical trial registry entries and their published results. This updates and expands WHO’s 2005 statement that “the registration of all interventional trials is a scientific, ethical, and moral responsibility”
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http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001819

Barb

barbc56 · Apr 15, 2015

Am wondering if this would help with releasing information from the PACE trial?

Barb

Esther12 · Apr 15, 2015

Might just be about getting some reporting of results, rather than worrying too much about how/whether results are spun.

Daisymay · Apr 16, 2015

http://www.alltrials.net/news/who-calls-for-all-clinical-trial-results-to-be-published/

"WHO calls for all clinical trial results to be published
14th April 2015

The World Health Organisation (WHO) made it unambiguously clear today that researchers have an ethical imperative to make results from all clinical trials – including past trials – publicly available. Its Statement on Public Disclosure of Clinical Trials Results:

says results from clinical trials should be publicly reported within 12 months of the trial’s end,

calls for results from previously unpublished trials to be made publicly available, and

calls on organisations and governments to implement measures to achieve this."

barbc56 · Apr 16, 2015

There's another thread here.

http://forums.phoenixrising.me/inde...sclosure-of-interventional-clinical-tr.36876/

@Kina @Sushi

Should these be merged.

@Daisymay Nice summary of important points.

Barb

JPV · Apr 19, 2015

This will never happen. The pharmaceutical industry is very powerfully and completely corrupt. They will fight against this sort of transparency tooth and nail. There's way too much money at stake for them to be honest about how useless and ineffective many of their most lucrative drugs really are...

Drug Companies & Doctors: A Story of Corruption (The New York Review of Books)

Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden. One clue was provided six years ago by four researchers who, using the Freedom of Information Act, obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. They found that on average, placebos were 80 percent as effective as the drugs. The difference between drug and placebo was so small that it was unlikely to be of any clinical significance. The results were much the same for all six drugs: all were equally ineffective. But because favorable results were published and unfavorable results buried (in this case, within the FDA), the public and the medical profession believed these drugs were potent antidepressants.
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In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors’ drugs—largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome. It is not unusual for a published paper to shift the focus from the drug’s intended effect to a secondary effect that seems more favorable.
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taniaaust1 · Apr 19, 2015

I'm thinking as JPV, its unlikely to happen as the drug companies carry too much power. They probably will some how end up with an opt out or something. It would be a massive change if 'WHO manages to get them all making the info easily available and public

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WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Tr

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