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- W3207568574 abstract "This chapter presents in detail the what, why and how of the study. It starts with the basic definitions and general aspects of clinical trials necessary for understanding the problem at issue. Next, the policy discourse and recent developments concerning access to non-summary trial data are outlined. In the EU, the controversy was intensified by the transparency policies of the European Medicines Agency (EMA), the evolving case law of the Court of Justice of the European Union (CJEU) on disclosure of clinical study reports by the EMA, the investigations of the European Ombudsman and the policy initiatives aimed to promote a data-driven economy. The Study’s objectives, questions and analytical approach are outlined against the backdrop of the legal scholarship on the subject of access to non-summary clinical trial data." @default.
- W3207568574 created "2021-10-25" @default.
- W3207568574 creator A5044321829 @default.
- W3207568574 date "2021-01-01" @default.
- W3207568574 modified "2023-09-26" @default.
- W3207568574 title "The Context and the Problem" @default.
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- W3207568574 doi "https://doi.org/10.1007/978-3-030-86778-2_2" @default.
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