No longer secret. A look at EMA's data release

[Tom Jefferson]

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.

[Christophe Kopp]

Some reservations based on our experience:

- we doubt that all that was announced in the 2010 EMA plan is accessible? Maybe on request but not online? 

- we saw no detailed agendas of monthly CHMP committees online

- we accessed a few assessment reports of variations (safety) online but nothing systematic

- there is no online access to reports of Scientific Advisory Groups who provide recommendations to CHMP

- EMA releases no data during MA or variation application procedures, including referral and review procedures

- PSURs are released but time lag between reported adverse reactions and approval of a pharmacovigilance variation by European Commisssion is too long: about 2 years

- access to suspected adverse drug reaction is very restrictive

- there are no comprehensive list of all documents held by EMA 

- total secrecy at EU Commission level about interactions between EC standing committees and  CHMP following its recommendations

- EPARs are summaries of data when you compare them with FDA reviews; we need FDA like extensive assessment reports

- EMA releases no pre-approval information whereas FDA has public committees that provide data 3-5 months before market release.

Cheers

Christophe Kopp

website:english.prescrire.org

De : Tom Jefferson <jeffer...@gmail.com>
Répondre à : "pathtodata...@googlegroups.com" <pathtodata...@googlegroups.com>
Date : mercredi 19 décembre 2012 15:17
À : "pathtodata...@googlegroups.com" <pathtodata...@googlegroups.com>
Objet : No longer secret. A look at EMA's data release