Share
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (in English)
Daria Kim
(Author)
·
Springer
· Hardcover
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (in English) - Kim, Daria
$ 132.62
$ 139.99
You save: $ 7.37
Choose the list to add your product or create one New List
✓ Product added successfully to the Wishlist.
Go to My WishlistsIt will be shipped from our warehouse between
Wednesday, June 12 and
Thursday, June 13.
You will receive it anywhere in United States between 1 and 3 business days after shipment.
Synopsis "Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (in English)"
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.
- 0% (0)
- 0% (0)
- 0% (0)
- 0% (0)
- 0% (0)
All books in our catalog are Original.
The book is written in English.
The binding of this edition is Hardcover.
✓ Producto agregado correctamente al carro, Ir a Pagar.