Fwd: EMA press release: Workshop kicks off process towards proactive publication of clinical trial data (ID:humtop)

[Peter Doshi]

Dear all (especially Trish),

Please see the final paragraph of the EMA's announcement.

Regards, Peter

-------- Original Message --------
Subject: EMA press release: Workshop kicks off process towards proactive
publication of clinical trial data (ID:humtop)
Date: Fri, 23 Nov 2012 12:52:45 +0000
From: The press group list <press...@list.ema.europa.eu>
Reply-To: pr...@ema.europa.eu
To: press...@list.ema.europa.eu <press...@list.ema.europa.eu>



23 November 2012
EMA/754763/2012
Press Office


Press release
Workshop on access to clinical-trial data and transparency kicks off
process towards proactive publication of data
Advisory groups to be formed to solve practical issues


"The European Medicines Agency is committed to proactive publication of
clinical-trial data, once the marketing-authorisation process has ended.
We are not here to decide if we publish clinical-trial data, but how",
this is how Guido Rasi, Executive Director of the Agency, opened the
workshop on access to clinical-trial data and transparency held on 22
November 2012.

This event marks the first step in the process to proactive publication
of clinical-trial data, a decision the Agency made earlier this year.
This decision aims to build trust and confidence in the system by
allowing re-analysis of clinical-trial data by stakeholders.

The Agency is aware that there are practical issues and other
considerations that need to be addressed and resolved. The workshop
allowed the Agency to gather the views, interests and concerns from a
broad range of institutions, groups and individuals.

Based on these discussions, Hans-Georg Eichler, Senior Medical Officer
at the Agency, presented the next step of the process. The Agency will
establish policies in close dialogue with its stakeholders in five
different areas identified during the workshop. These are:
* protecting patient confidentiality;
* clinical-trial-data formats;
* rules of engagement;
* good analysis practice;
* legal aspects.

Advisory groups with broad representation from all parties will be
formed and will start working on these topics in early 2013. Final
advice from each group is expected by the end of April 2013. The
proactive publication of clinical-trial data is expected to come into
force on 1 January 2014. Details about how to express interest in
participating in these advisory groups will be published shortly on the
Agency's website.

While the work on proactive disclosure is ongoing, the Agency's approach
to reactive disclosure of data remains unchanged. Since November 2010,
the Agency has released over 1.5 million pages of clinical-trial data in
response to safety-related requests.

Notes
1. This press release, together with all related documents, is available
on the Agency's website:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/11/news_detail_001662.jsp&mid=WC0b01ac058004d5c1

2. The Agenda of the workshop is available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2012/07/WC500130161.pdf
3. The Agency's decision to move towards proactive disclosure was first
outlined in the article 'Open Clinical trial Data for All? A View from
Regulators', PLoS Medicine, April 2012. This article is available at:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001202
4. Biographies of the speakers who participated in the workshop are
available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/11/WC500134994.pdf
5. More information on the work of the European Medicines Agency can be
found on its website: www.ema.europa.eu


Contact our press officer
Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: pr...@ema.europa.eu


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[PATH]

Thanks Peter - that is reassuring as far as it goes. I wish this had been set out more clearly at the meeting. A clearer remit would have resulted in a much better focussed discussion. Richard

[Trish Groves]

Good to see this press release; thanks.
But it uses the terms "proactive" (spontaneous) and "reactive" (on request) so we're still none the wiser about "prospective" and "retrospective". And I don't think we can put this down to Franglais.
bw
Trish

Dr Trish Groves
Deputy editor, BMJ
and Editor-in-chief, BMJ Open

+44 207 383 6018
bmj.com - the open access journal
bmjopen.bmj.com
BMJ Group: http://group.bmj.com
twitter @trished

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