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Access to regulatory data from the European Medicines Agency: the times they are a-changing

Overview of attention for article published in Systematic Reviews, October 2012
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  • Above-average Attention Score compared to outputs of the same age (53rd percentile)
  • Average Attention Score compared to outputs of the same age and source

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42 Mendeley
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Access to regulatory data from the European Medicines Agency: the times they are a-changing
Published in
Systematic Reviews, October 2012
DOI 10.1186/2046-4053-1-50
Pubmed ID

Beate Wieseler, Natalie McGauran, Michaela F Kerekes, Thomas Kaiser


Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. In the case of the inhaled insulin Exubera, the manufacturer refused to cooperate and in 2007 we asked the European Medicines Agency (EMA) to provide the relevant CSRs, but EMA denied access. Other researchers have reported similar experiences.In 2010 EMA introduced a new policy on access to regulatory documents, including CSRs, and has also undertaken further steps. The new policy has already borne fruit: in 2011, by providing additional sections of relevant CSRs, EMA made an important contribution to a review of oseltamivir (Tamiflu).Unfortunately, speedy implementation of the new policy may be endangered. We define a CSR following the International Conference on Harmonisation (ICH) E3 guideline. Although this guideline requires individual patient data listings, it does not necessarily require that these listings be made available in a computer-readable format, as proposed by some regulators from EMA and other agencies. However, access to raw data in a computer-readable format poses additional problems; merging this issue with that of access to CSRs could hamper the relatively simple implementation of the EMA policy. Moreover, EMA plans to release CSRs only on request; we suggest making these documents routinely available on the EMA website.Public access to regulatory data also carries potential risks. In our view, the issue of patient confidentiality has been largely resolved by current European legislation. The risk of other problems, such as conflicts of interest (CoIs) of independent researchers or quality issues can be reduced by transparency measures, such as the implementation of processes to evaluate CoIs and the publication of methods and protocols.In conclusion, regulatory data are an indispensable source for systematic reviews. Because of EMA's policy change, a milestone for data transparency in clinical research is within reach; let's hope it is not unnecessarily delayed.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 42 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 2%
Spain 1 2%
Portugal 1 2%
Unknown 39 93%

Demographic breakdown

Readers by professional status Count As %
Researcher 15 36%
Student > Master 5 12%
Student > Ph. D. Student 4 10%
Other 4 10%
Professor > Associate Professor 3 7%
Other 7 17%
Unknown 4 10%
Readers by discipline Count As %
Medicine and Dentistry 18 43%
Nursing and Health Professions 4 10%
Pharmacology, Toxicology and Pharmaceutical Science 3 7%
Social Sciences 3 7%
Agricultural and Biological Sciences 2 5%
Other 6 14%
Unknown 6 14%

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 December 2012.
All research outputs
of 12,440,173 outputs
Outputs from Systematic Reviews
of 1,005 outputs
Outputs of similar age
of 142,009 outputs
Outputs of similar age from Systematic Reviews
of 35 outputs
Altmetric has tracked 12,440,173 research outputs across all sources so far. This one is in the 44th percentile – i.e., 44% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,005 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 12.0. This one is in the 29th percentile – i.e., 29% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 142,009 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 53% of its contemporaries.
We're also able to compare this research output to 35 others from the same source and published within six weeks on either side of this one. This one is in the 45th percentile – i.e., 45% of its contemporaries scored the same or lower than it.