{"id":50583,"date":"2014-10-09T00:15:16","date_gmt":"2014-10-09T04:15:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=50583"},"modified":"2014-10-09T06:36:18","modified_gmt":"2014-10-09T10:36:18","slug":"anything-but-over","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/10\/09\/anything-but-over\/","title":{"rendered":"anything but over…"},"content":{"rendered":"
Tom Jefferson is a researcher\/reviewer with the Cochrane Collaboration. He was involved throughout in the Tamiflu story and the Cochrane meta-analysis of the Tamiflu Trials. He’s as good a resource as we might find for understanding what the EMA’s recent policy decision really says: <\/div>\n
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EMA’s release of regulatory data — trust but verify<\/a><\/div>\n
British Medical Journal blog <\/font><\/strong><\/div>\n
by Tom Jefferson<\/div>\n
7 Oct, 14<\/div>\n

The European Medicines Agency [EMA] has now released the final version of its policy<\/a> on the prospective release of clinical reports of trials, which are submitted by sponsors to support marketing authorisation applications [MAAs]. The agency has said that it will—at a future date—determine how to release individual participant data [IPD].<\/p>\n

Scope<\/font><\/strong>
The policy—to become effective from 1 January 2015—explains what will be released and how. Full clinical study reports will not be released. Rather, selected parts of clinical study reports will be released, including the “core report” [although this is not labelled as such in the text], the statistical analysis plan, protocol and its amendments, and a blank case report form. [To those familiar with clinical study reports, these are sections 1-15, 16.1.1, 16.1.2, and 16.1.9 of the ICH E3 guidelines<\/a>.] The policy document does not explain why full clinical study reports will not be released.<\/div>\n<\/blockquote>\n
This «core report»<\/font> for the CSR [Clinical Study Report] is what I was worried about [beyond the blind…<\/a>]. And it for sure won’t have the IPD [Individual Participant Data]. Having the «statistical analysis plan, protocol and its amendments»<\/font> is a good thing. But does it pass the Rolling Stones test?<\/div>\n