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Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (Paperback, 1st ed. 2021)
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Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (Paperback, 1st ed. 2021)
Series: Munich Studies on Innovation and Competition, 16
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This book draws a unique perspective on the regulation of access to
clinical trial data as a case on research and knowledge
externalities. Notwithstanding numerous potential benefits for
medical research and public health, many jurisdictions have
struggled to ensure access to clinical trial data, even at the
level of the trial results. Pro-access policy initiatives have been
strongly opposed by research-based drug companies arguing that
mandatory data disclosure impedes their innovation incentives.
Conventionally, access to test data has been approached from the
perspective of transparency and research ethics. The book offers a
complementary view and considers access to individual patient-level
trial data for exploratory analysis as a matter of research and
innovation policy. Such approach appears to be especially relevant
in the data-driven economy where digital data constitutes a
valuable economic resource. The study seeks to define how the rules
of access to clinical trial data should be designed to reconcile
the policy objectives of leveraging the research potential of data
through secondary analysis, on the one hand, and protecting
economic incentives of research-based drug companies, on the other
hand. Overall, it is argued that the mainstream innovation-based
justification for exclusive control over the outcomes of research
and development can hardly rationalise trial sponsors' control over
primary data from trials. Instead, access to such data and its
robust analysis should be prioritised.
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