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Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

Overview of attention for article published in Trials, July 2012
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Title
Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data
Published in
Trials, July 2012
DOI 10.1186/1745-6215-13-100
Pubmed ID
Authors

Daniel Strech, Jasper Littmann

Abstract

For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1) what kinds of commercial interests remain relevant after market approval has been granted, (2) what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3) what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

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Mendeley readers

The data shown below were compiled from readership statistics for 36 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 3%
United States 1 3%
Denmark 1 3%
France 1 3%
Unknown 32 89%

Demographic breakdown

Readers by professional status Count As %
Researcher 12 33%
Student > Master 3 8%
Professor 2 6%
Librarian 2 6%
Student > Ph. D. Student 2 6%
Other 6 17%
Unknown 9 25%
Readers by discipline Count As %
Medicine and Dentistry 17 47%
Social Sciences 4 11%
Philosophy 2 6%
Arts and Humanities 1 3%
Computer Science 1 3%
Other 3 8%
Unknown 8 22%