European regulator gives public access to Clinical trial data for drug trials

Simon

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European regulator confirms milestone medical-data transparency rules : Nature News Blog

... the policy “sets a new standard for transparency in public health and pharmaceutical research and development” and would provide an “unprecedented level of access to clinical reports”.

This policy has been subject of fierce debate since it was first proposed, with transparency campaigners claiming the EMA was not being bold enough, ...And industry has feared that commercially sensitive information would be released, and this could compromise their long-term ability to invest in research.

A key change from earlier versions of the policy is that researchers, and other members of the public, will now be able to download data...
 

Esther12

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That actually sounds really good. It's always hard to know how things will actually be put into action, but it sounded much better than I expected.
 

Scarecrow

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Wow! I wonder how that stacks up against what Peter White said in Bristol last month:

PACE: A trial & tribulations
Prof Peter White, Barts and the London School of Medicine and Dentistry

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Prof White continued by outlining the reactions to the PACE trial from some M.E. patient activists and organisations, which have to date included formal complaints (none upheld), petitions, and a total of 168 Freedom of Information (FOI) Act individual data requests (he had to count them all because he received an FOI Act request asking for the number.)
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“The PACE trial has also played a small role in helping to amend the FOI Act for the better. From 1 October, current research will be exempt from the FOI Act so long as it can be shown that release of that data will be prejudicial to the conduct of the research."
 

Seven7

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What is different about this trial than others where the data has been released??? I am just wondering what is the reasoning to such ambiguity and secrecy, the more they resist the more curious I get.
 

Valentijn

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What is different about this trial than others where the data has been released??? I am just wondering what is the reasoning to such ambiguity and secrecy, the more they resist the more curious I get.
Shoddy methodology and a lot of spin.
 
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