Dear
friends,
The European Medicines Agency (EMA) is getting a lot of attention because of
their stated intent to start making clinical
trial data public. But often overlooked is the fact that EMA has already
been releasing data -- in fact, over 1.6 million pages of documents since
November 2010, to anybody who asks for it, free of charge.
We have
completed an analysis of the first two years of this policy -- published this
week in Archives of Internal Medicine (URL) together with a linked commentary--
showing that previously secret documents as diverse as clinical study reports,
assessment reports, and periodic safety update reports (PSURs) are being
released, no strings attached, and often in large batches.
How can the FDA continue to see clinical trial data as a trade secret when its
"cousin" in Europe has opened the fire hydrant?
How can the pharmaceutical industry remain opposed to true open access to data when
it turns out that so far industry been the most frequent requestor -- and
greatest recipient -- of documents from EMA?
These are some of the questions we hope our analysis will provoke.
The
EMA's natural experiment in open access to data sharing has, in significant
ways, already begun. We will continue to watch eagerly to see how it
plays out.
Doshi P, Jefferson T. The first 2 years of the European Medicines Agency’s
policy on access to documents: Secret no Longer. Arch Intern Med. Published
online December 19, 2012. doi: http://dx.doi.org/10.1001/jamainternmed.2013.3838 (from 1600 CET).
Regards,
Peter Doshi and Tom Jefferson.