PharmaTimesby Peter MansellJanuary 10, 2013The push from the UK for wholesale transparency of clinical-trial data has taken on a new dimension with the launch of the AllTrials public campaign. An accompanying petition – already
close to 3,000over 7,000 signatures at the time of writing – calls on governments, regulators and research bodies to put in place measures ensuring that “all trials past and present” are registered and “the full methods and the results” reported. The initiative follows last month’s call by the UK House of Commons Science and Technology Committee for submissions on transparency and the disclosure of study data as part of a broader inquiry into clinical trials.Among the campaign backers are some familiar names in the recent drive for clinical-data transparency: Bad Science – i.e., epidemiologist and Bad Pharma author Dr. Ben Goldacre; the BMJ; the James Lind Initiative; and the Centre for Evidence-Based Medicine. Joining them in the campaign is Sense About Science, a UK-based charitable trust that works in partnership with scientific bodies, research publishers, policymakers, the public and the media to change public discussions about science and evidence.
Sense About Science director Tracey Brown commented: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements.” Government and regulators “must listen to what the public thinks about this”, Brown insisted. “It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future”…
Who is James Lind? He’s the 18th centery British Naval Surgeon who did the first real controlled clinical trial – citrus fruits for Scurvy [he published his data and did a literature review]…
So I thought I’d go back to the Proprietary Data Act and see why they were given that right in the first place. Only I couldn’t find the Proprietary Data Act anywhere no matter what I put in Google®. That happens, so I wrote everyone I knew asking for leads. They kindly agreed to help, but they couldn’t quite recall – Was it Congress back in 1962? Just not sure. So they looked and couldn’t come up with anything either. So how am I going to mount a campaign to Repeal the Proprietary Data Act if I can’t even find it?
I finally heard from some people-in-the-know who had obviously gone on the same Hegira and found nothing either. It just happened apparently. The pharmaceutical companies had the data from the CROs they hired, and they kept it to themselves. There is no Proprietary Data Act. Never was. I guess it’s something like staking a claim in the Klondike during the gold rush or squatter’s rights. So much for my Repeal the Proprietary Data Act Movement..
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