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  • © 2021

Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law

Authors:

  • Provides a unique perspective on the regulation of access to clinical trial data as a case on knowledge externalities

  • Reveals limitations and inconsistencies of the current regulatory approach to access to clinical trial data

  • Proposes a legislative solution of how access to non-summary clinical trial data can be integrated

Part of the book series: Munich Studies on Innovation and Competition (MSIC, volume 16)

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  • ISBN: 978-3-030-86778-2
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Hardcover Book USD 159.99
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Table of contents (10 chapters)

  1. Front Matter

    Pages i-xviii
  2. Introduction

    • Daria Kim
    Pages 1-6
  3. Setting the Scene

    1. Front Matter

      Pages 7-7
    2. The Context and the Problem

      • Daria Kim
      Pages 9-43
  4. Back Matter

    Pages 297-300

About this book

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.

Keywords

  • Clinical trail data
  • Competition in innovation
  • Exploratory data analysis
  • Access to data
  • Drug research and development

Authors and Affiliations

  • Max Planck Institute for Innovation and Competition, Munich, Germany

    Daria Kim

About the author

Daria Kim is senior research fellow at the Max Planck Institute for Competition and Innovation (Munich), where she works on the topics related to the regulation of the data economy and life sciences. Prior to joining Max Planck Institute, she worked as a research associate at the Chinese University of Hong Kong. She holds MA (Indiana University of Pennsylvania), LLM (Munich Intellectual Property Law Center) and Dr. iur. (the University of Augsburg) degrees.

Bibliographic Information

Buying options

eBook USD 119.00
Price excludes VAT (USA)
  • ISBN: 978-3-030-86778-2
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Hardcover Book USD 159.99
Price excludes VAT (USA)