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