Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law:
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, ev...
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| Beteilige Person: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
| Veröffentlicht: |
Cham
Springer International Publishing
2021
|
| Ausgabe: | 1st edition |
| Schriftenreihe: | Munich Studies on Innovation and Competition
Volume 16 |
| Schlagwörter: | |
| Links: | https://doi.org/10.1007/978-3-030-86778-2 https://doi.org/10.1007/978-3-030-86778-2 https://doi.org/10.1007/978-3-030-86778-2 |
| Zusammenfassung: | 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 |
| Umfang: | 1 Online-Ressource (XVIII, 300 Seiten) |
| ISBN: | 9783030867782 |
| DOI: | 10.1007/978-3-030-86778-2 |
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| spelling | Kim, Daria Verfasser (DE-588)124701598X aut Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law Daria Kim 1st edition Cham Springer International Publishing 2021 1 Online-Ressource (XVIII, 300 Seiten) txt rdacontent c rdamedia cr rdacarrier Munich Studies on Innovation and Competition Volume 16 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 IT Law, Media Law, Intellectual Property Medical Law European Law Biomedicine, general Statistics, general Mass media Law Medical laws and legislation Law-Europe Medicine Statistics Embryo (DE-588)4014555-4 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Schutz (DE-588)4180271-8 gnd rswk-swf Recht (DE-588)4048737-4 gnd rswk-swf Reproduktionsmedizin (DE-588)4197011-1 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf Deutschland (DE-588)4011882-4 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Deutschland (DE-588)4011882-4 g Reproduktionsmedizin (DE-588)4197011-1 s Embryo (DE-588)4014555-4 s Schutz (DE-588)4180271-8 s Forschung (DE-588)4017894-8 s Biotechnologie (DE-588)4069491-4 s DE-604 Recht (DE-588)4048737-4 s Erscheint auch als Druck-Ausgabe 978-3-030-86777-5 Erscheint auch als Druck-Ausgabe 9783030867799 Erscheint auch als Druck-Ausgabe 9783030867805 Munich Studies on Innovation and Competition Volume 16 (DE-604)BV043768297 16 https://doi.org/10.1007/978-3-030-86778-2 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Kim, Daria Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law Munich Studies on Innovation and Competition IT Law, Media Law, Intellectual Property Medical Law European Law Biomedicine, general Statistics, general Mass media Law Medical laws and legislation Law-Europe Medicine Statistics Embryo (DE-588)4014555-4 gnd Forschung (DE-588)4017894-8 gnd Schutz (DE-588)4180271-8 gnd Recht (DE-588)4048737-4 gnd Reproduktionsmedizin (DE-588)4197011-1 gnd Biotechnologie (DE-588)4069491-4 gnd |
| subject_GND | (DE-588)4014555-4 (DE-588)4017894-8 (DE-588)4180271-8 (DE-588)4048737-4 (DE-588)4197011-1 (DE-588)4069491-4 (DE-588)4011882-4 (DE-588)4113937-9 |
| title | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law |
| title_auth | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law |
| title_exact_search | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law |
| title_full | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law Daria Kim |
| title_fullStr | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law Daria Kim |
| title_full_unstemmed | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law Daria Kim |
| title_short | Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law |
| title_sort | access to non summary clinical trial data for research purposes under eu law |
| topic | IT Law, Media Law, Intellectual Property Medical Law European Law Biomedicine, general Statistics, general Mass media Law Medical laws and legislation Law-Europe Medicine Statistics Embryo (DE-588)4014555-4 gnd Forschung (DE-588)4017894-8 gnd Schutz (DE-588)4180271-8 gnd Recht (DE-588)4048737-4 gnd Reproduktionsmedizin (DE-588)4197011-1 gnd Biotechnologie (DE-588)4069491-4 gnd |
| topic_facet | IT Law, Media Law, Intellectual Property Medical Law European Law Biomedicine, general Statistics, general Mass media Law Medical laws and legislation Law-Europe Medicine Statistics Embryo Forschung Schutz Recht Reproduktionsmedizin Biotechnologie Deutschland Hochschulschrift |
| url | https://doi.org/10.1007/978-3-030-86778-2 |
| volume_link | (DE-604)BV043768297 |
| work_keys_str_mv | AT kimdaria accesstononsummaryclinicaltrialdataforresearchpurposesundereulaw |