Daria Kim
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law
YOU SAVE £14.17
- Condition: Brand new
- UK Delivery times: Usually arrives within 2 - 3 working days
- UK Shipping: Fee starts at £2.39. Subject to product weight & dimension
Couldn't load pickup availability
- More about Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law
This book explores the regulation of access to clinical trial data from a research and knowledge externalities perspective. It argues that mandatory data disclosure can impede innovation incentives and proposes that access to individual patient-level trial data for exploratory analysis should be prioritized. 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 with protecting economic incentives of research-based drug companies.
Format: Hardback
Length: 300 pages
Publication date: 20 October 2021
Publisher: Springer Nature Switzerland AG
This captivating book delves into a distinctive perspective on the regulation of access to clinical trial data, presenting it as a case study on research and knowledge externalities. While numerous potential benefits for medical research and public health abound, many jurisdictions have faced challenges in ensuring seamless access to clinical trial data, even when it comes to trial results. Pro-access policy initiatives have encountered strong opposition from research-based drug companies, who argue that mandatory data disclosure hinders their innovation incentives. Traditionally, access to test data has been approached from the lenses of transparency and research ethics. However, this book offers a complementary viewpoint, emphasizing the importance of access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. In the context of the data-driven economy, where digital data holds immense economic value, such an approach becomes particularly relevant. The study aims to establish guidelines for designing access rules to clinical trial data, balancing the policy objectives of maximizing the research potential of data through secondary analysis while safeguarding the economic incentives of research-based drug companies.
Overall, the book makes a compelling argument that the mainstream innovation-based justification for exclusive control over the outcomes of research and development fails to rationalize trial sponsors' control over primary data from trials. Instead, prioritizing access to such data and its rigorous analysis should be the guiding principle.
This captivating book delves into a distinctive perspective on the regulation of access to clinical trial data, presenting it as a case study on research and knowledge externalities. While numerous potential benefits for medical research and public health abound, many jurisdictions have faced challenges in ensuring seamless access to clinical trial data, even when it comes to trial results. Pro-access policy initiatives have encountered strong opposition from research-based drug companies, who argue that mandatory data disclosure hinders their innovation incentives. Traditionally, access to test data has been approached from the lenses of transparency and research ethics. However, this book offers a complementary viewpoint, emphasizing the importance of access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. In the context of the data-driven economy, where digital data holds immense economic value, such an approach becomes particularly relevant. The study aims to establish guidelines for designing access rules to clinical trial data, balancing the policy objectives of maximizing the research potential of data through secondary analysis while safeguarding the economic incentives of research-based drug companies.
Overall, the book makes a compelling argument that the mainstream innovation-based justification for exclusive control over the outcomes of research and development fails to rationalize trial sponsors' control over primary data from trials. Instead, prioritizing access to such data and its rigorous analysis should be the guiding principle.
This captivating book delves into a distinctive perspective on the regulation of access to clinical trial data, presenting it as a case study on research and knowledge externalities. While numerous potential benefits for medical research and public health abound, many jurisdictions have faced challenges in ensuring seamless access to clinical trial data, even when it comes to trial results. Pro-access policy initiatives have encountered strong opposition from research-based drug companies, who argue that mandatory data disclosure hinders their innovation incentives. Traditionally, access to test data has been approached from the lenses of transparency and research ethics. However, this book offers a complementary viewpoint, emphasizing the importance of access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. In the context of the data-driven economy, where digital data holds immense economic value, such an approach becomes particularly relevant. The study aims to establish guidelines for designing access rules to clinical trial data, balancing the policy objectives of maximizing the research potential of data through secondary analysis while safeguarding the economic incentives of research-based drug companies.
Overall, the book makes a compelling argument that the mainstream innovation-based justification for exclusive control over the outcomes of research and development fails to rationalize trial sponsors' control over primary data from trials. Instead, prioritizing access to such data and its rigorous analysis should be the guiding principle.
This captivating book delves into a distinctive perspective on the regulation of access to clinical trial data, presenting it as a case study on research and knowledge externalities. While numerous potential benefits for medical research and public health abound, many jurisdictions have faced challenges in ensuring seamless access to clinical trial data, even when it comes to trial results. Pro-access policy initiatives have encountered strong opposition from research-based drug companies, who argue that mandatory data disclosure hinders their innovation incentives. Traditionally, access to test data has been approached from the lenses of transparency and research ethics. However, this book offers a complementary viewpoint, emphasizing the importance of access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. In the context of the data-driven economy, where digital data holds immense economic value, such an approach becomes particularly relevant. The study aims to establish guidelines for designing access rules to clinical trial data, balancing the policy objectives of maximizing the research potential of data through secondary analysis while safeguarding the economic incentives of research-based drug companies.
Overall, the book makes a compelling argument that the mainstream innovation-based justification for exclusive control over the outcomes of research and development fails to rationalize trial sponsors' control over primary data from trials. Instead, prioritizing access to such data and its rigorous analysis should be the guiding principle.
Weight: 647g
Dimension: 235 x 155 (mm)
ISBN-13: 9783030867775
Edition number: 1st ed. 2021
This item can be found in:
UK and International shipping information
UK and International shipping information
UK Delivery and returns information:
- Delivery within 2 - 3 days when ordering in the UK.
- Shipping fee for UK customers from £2.39. Fully tracked shipping service available.
- Returns policy: Return within 30 days of receipt for full refund.
International deliveries:
Shulph Ink now ships to Australia, Canada, France, Ireland, Italy, Germany, Spain, Netherlands, New Zealand, United States of America, Belgium, India, United Arab Emirates.
- Delivery times: within 5 - 10 days for international orders.
- Shipping fee: charges vary for overseas orders. Only tracked services are available for international orders.
- Customs charges: If ordering to addresses outside the United Kingdom, you may or may not incur additional customs and duties fees during local delivery.
![Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law](http://shulphink.com/cdn/shop/products/1646400316705_book.jpg?v=1646993993&width=1445)