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The EMA conditions of use for clinical study data

Update, October 2014:

On 12 June 2014 the European Medicines Agency (EMA) will decide on new rules for the publication of clinical study data. In 2013 EMA had announced that in future, they would make all clinical study reports submitted to them publicly accessible and thus increase transparency with regard to the benefits and harms of drugs.

Not much remains of these plans. It became known on 20 May that researchers and other interested parties will only be allowed to view the data on screen. Essential functions for working with the study data will be forbidden:

Interested parties will not be allowed to

  • download
  • save
  • edit
  • photograph
  • print
  • distribute or
  • transfer

the information provided in the clinical study reports.

Benefit assessments of drugs, for which often thousands of pages of documents are analysed, will thus be impossible, as such assessments require data extraction, pooling and analysis. This applies all the more to meta-analyses: for this type of evaluation, in some cases research teams located around the world may require years of work to analyse over a hundred thousand pages of materials.

In addition, pharmaceutical companies are to be allowed to submit two versions of their clinical study reports to EMA: a complete one for the approval of their drugs, and an incomplete one for the public. In the latter version, study results may be deleted (e.g., results referring to the question as to whether the quality of life of patients improves or deteriorates under treatment).

What this means in practice ...

IQWiG researchers show here what their work would look like under the new EMA conditions. Can also be followed on twitter with the hashtag #screenonly.

Update 13 June 2014:

On 12 June 2014, EMA decided not to adopt the “screen only” version of the policy on publication of clinical trial data. Instead, the policy is now to include the following procedure:

  • proactive publication by EMA of trial data submitted as part of marketing authorisation applications
  • possibility to download, save and print the data for academic and non-commercial purposes

It remains to be seen in the new version of the policy whether any additional aspects have been changed. Presumably in mid-July, this version will be commented on and adopted by the members of the Management Board, before the final version will become effective from October 2014.

EMA press release from 12 June 2014:
European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments

IQWiG at Twitter: @iqwig

Blind date/a: Bracing ourselfs for EMA's #screenonly decision tomorrow.
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Back to the future. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Still practicing EMA-compliant data retrieval, in case of #screenonly decision on thursday.
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Blimey! Bad lighting conditions today. Can't check the endpoint definitions. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Take care: Working #screenonly could unbalance your mind. ;-)
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Due to arm length restrictions, the #ctdata team size had to be limited to 3.
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Would #EMA #screenonly catch the birds who are flies?
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Magic: the only data retrieval method not prohibited by EMA’s terms of use? #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

The HTA agencies soon found some fancy loopholes in EMA's #screenonly policy. 
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

EMA-compliant #screenonly working mode. The IT department is not amused. 
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

"What?! But breathing is still allowed, I presume?" #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

All data look great when you put on your exploratory endpoint redaction glasses.
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Data processing under the terms of #EMA - just like in the olden days ... #screenonly 
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

(G)EMA-Witze versteht man eh nur auf Deutsch, oder? ;-) #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Side effect: nervosity. Analysing #ctdata under a sword of Damocles. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

LtCdr #CTData was puzzled: He wanted to help. So why did they lock him in? #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

"Wait a sec: is tracing admitted or not?" HTA in a legal limbo. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Pia hated standing on a redacted pasture. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

After 16 hours of staring, Rupert felt that the data started staring back at him. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Traditional methods of data analysis are back again - thanks, #EMA! #screenonly
More Tweets:  https://twitter.com/hashtag/@iqwig?f=realtime

The dark future of health technology assessment, #EMA style. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime

Three wise monkeys - see no data, hear no data, speak no data. #screenonly
More Tweets: https://twitter.com/hashtag/@iqwig?f=realtime


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